Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease
START-CKD
1 other identifier
interventional
756
2 countries
249
Brief Summary
A phase 3, multicenter, randomized, double-blind, parallel group study. Anemic subjects with chronic kidney disease (CKD) and not on dialysis will be randomized 1:1 to 1 of 2 dosing strategies to evaluate the proportion of subjects receiving at least one red blood cell (RBC) transfusion. In the haemoglobin (Hb)-based titration group, darbepoetin alfa doses will be titrated to maintain Hb ≥ 10.0 grams/deciliter (g/dL). In the fixed dose group, subjects will receive a fixed dose of darbepoetin alfa. Treatment group, darbepoetin alfa doses, and protocol specified Hb concentrations will be blinded. Subjects will be followed for approximately 2 years from the date of randomization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2012
Longer than P75 for phase_3
249 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
July 30, 2012
CompletedStudy Start
First participant enrolled
July 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2017
CompletedResults Posted
Study results publicly available
November 8, 2018
CompletedSeptember 21, 2022
September 1, 2022
5.2 years
June 7, 2012
October 11, 2018
September 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants in Receipt of 1 or More RBC Transfusions
The percentage of participants receiving at least 1 RBC transfusion during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach).
From randomization until the end of study, up to week 101.
Secondary Outcomes (4)
Mean Number of Units of RBC Transfused
From randomization until the end of study, up to week 101.
Time to First RBC Transfusion
From randomization until the end of study, up to week 101.
Mean Achieved Hb Concentration While Receiving Investigational Product
From week 13 until the end of study, up to week 101.
Geometric Mean Cumulative Dose of Darbepoetin Alfa Per 4 Weeks
From randomization until the end of study, up to week 101.
Study Arms (2)
Hb-Based Titration Group
ACTIVE COMPARATORParticipants received darbepoetin alfa as a subcutaneous (SC) injection once every 4 weeks (Q4W) for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb rate of rise (ROR), and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 micrograms/kilogram (mcg/kg) and the protocol specified doses ranged from 10 to 300 mcg.
Fixed Dose Group
EXPERIMENTALParticipants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96 week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was \> 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to \< 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Interventions
Darbepoetin alfa was presented as single use prefilled syringes (PFS). Investigational product was administered SC Q4W for the duration of the treatment period.
Placebo was presented as single use PFS. Participants received a SC placebo injection in place of darbepoetin alfa therapy when the dose of study drug was withheld per the dosing algorithm for the duration of the treatment period.
Eligibility Criteria
You may qualify if:
- Clinical history of advanced CKD not on dialysis with at least 1 historic estimated glomerular filtration rate (eGFR) \< 45.0 mL/mi)/1.73 m2 at least 12 weeks prior to screening
- Not currently receiving dialysis with an eGFR \< 45.0 mL/min/1.73m2, per the central laboratory during screening
- Chronic anemia due to renal failure
- Two Hb concentrations \< 10.0 g/dL, at least 2 weeks apart during screening using the modified Hb point of care (POC) device
- Iron replete, defined as a transferrin saturation (TSAT) ≥ 20% and a ferritin ≥ 100 ng/mL, per the central laboratory during screening
- Vitamin B12 and folate replete, defined as a vitamin B12 level \> 180 pg/mL and a folate concentration \> 7 nmol/L, per the central laboratory during screening
- Clinically stable in the opinion of the investigator
- Subject has provided written informed consent
You may not qualify if:
- Systemic hematologic disease (eg, sickle cell anemia, myelodysplastic syndrome, hematologic malignancy)
- Current or prior malignancy within 5 years of screening, with the exception of non-melanoma skin cancers and cervical intraepithelial neoplasia
- Treatment for any malignancy (eg, radiation, chemotherapy, hormone therapy, or biologics) within 5 years of screening, with the exception of locally excised non-melanoma skin cancer or cervical intraepithelial neoplasia
- Female subject not willing to use highly effective methods of birth control during treatment and for 4 weeks after the end of treatment
- Subject is pregnant or breast feeding, or might become pregnant during the study or within 4 weeks after the end of treatment
- Currently receiving intravenous (IV) antibiotics for treatment of an active infection
- Known Human Immunodeficiency Virus (HIV) positive
- Currently receiving systemic immunosuppressive therapy with the exception of prednis(ol)one ≤ 10 mg per day (or the steroid equivalent)
- History of any organ transplant
- Currently enrolled in another interventional study (eg, studies which require medical device use or drug therapy or with protocol required procedures), or less than 4 weeks since ending another interventional study(s) or receiving investigational agent(s)
- Known neutralizing anti-erythropoietic protein antibodies
- Known sensitivity to any of the products to be administered during dosing
- Previously enrolled in this study
- Not expected to be available for protocol required study visits or procedures to the best of the subject and investigator's knowledge
- Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with all required study procedures
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (249)
Research Site
Anniston, Alabama, 36207, United States
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Birmingham, Alabama, 35235, United States
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Huntsville, Alabama, 35801, United States
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Mobile, Alabama, 36608, United States
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Mobile, Alabama, 36617, United States
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Montgomery, Alabama, 36106, United States
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Goodyear, Arizona, 85395, United States
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Peoria, Arizona, 85381, United States
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Phoenix, Arizona, 85004, United States
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Phoenix, Arizona, 85012, United States
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Phoenix, Arizona, 85032, United States
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Tempe, Arizona, 85284, United States
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Little Rock, Arkansas, 72204, United States
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Alhambra, California, 91801, United States
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Anaheim, California, 92805, United States
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Azusa, California, 91702, United States
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Bakersfield, California, 93301, United States
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Bakersfield, California, 93309, United States
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Bell Gardens, California, 90201, United States
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Beverly Hills, California, 90211, United States
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Cerritos, California, 90703, United States
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Chula Vista, California, 91910, United States
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Cudahy, California, 90201, United States
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El Centro, California, 92243, United States
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Fountain Valley, California, 92708, United States
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Fullerton, California, 92835, United States
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Garden Grove, California, 92844, United States
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Glendale, California, 91204, United States
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Granada Hills, California, 91344, United States
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Huntington Beach, California, 92648, United States
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Inglewood, California, 90301, United States
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La Jolla, California, 92037, United States
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La Mesa, California, 91942, United States
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Laguna Hills, California, 92653, United States
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Lakewood, California, 90712, United States
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Lancaster, California, 93534, United States
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Lomita, California, 90717, United States
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Long Beach, California, 90813, United States
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Los Angeles, California, 90015, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90022, United States
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Los Angeles, California, 90025, United States
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Lynwood, California, 90262, United States
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Mission Hills, California, 91345, United States
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Modesto, California, 95350, United States
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Northridge, California, 91324, United States
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Northridge, California, 91325, United States
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Orange, California, 92868, United States
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Rancho Mirage, California, 92270, United States
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Redondo Beach, California, 90277, United States
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Riverside, California, 92505, United States
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Sacramento, California, 95825, United States
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San Dimas, California, 91773, United States
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Whittier, California, 90602, United States
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Whittier, California, 90603, United States
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Yuba City, California, 95991, United States
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Arvada, Colorado, 80002, United States
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Westminster, Colorado, 80031, United States
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Middlebury, Connecticut, 06762, United States
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New Haven, Connecticut, 06511, United States
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North Haven, Connecticut, 06473, United States
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Washington D.C., District of Columbia, 20037, United States
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Boynton Beach, Florida, 33472, United States
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Coral Springs, Florida, 33071, United States
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Daytona Beach, Florida, 32117, United States
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DeLand, Florida, 32720, United States
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Fort Lauderdale, Florida, 33308, United States
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Hollywood, Florida, 33021, United States
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Hudson, Florida, 34667, United States
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Jacksonville, Florida, 32216, United States
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Jacksonville Beach, Florida, 32250, United States
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Lauderdale Lakes, Florida, 33313, United States
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Melbourne, Florida, 32901, United States
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Melbourne, Florida, 32935, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33150, United States
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Miami, Florida, 33166, United States
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Miami, Florida, 33173, United States
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Miami Beach, Florida, 33140, United States
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Naples, Florida, 34110, United States
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New Port Richey, Florida, 34652, United States
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New Port Richey, Florida, 34653, United States
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Orlando, Florida, 32804, United States
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Pembroke Pines, Florida, 33028, United States
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Port Charlotte, Florida, 33952, United States
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Summerfield, Florida, 34491, United States
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Tampa, Florida, 33603, United States
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Tampa, Florida, 33612, United States
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Tampa, Florida, 33614, United States
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Atlanta, Georgia, 30342, United States
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Augusta, Georgia, 30909, United States
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Canton, Georgia, 30114, United States
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Macon, Georgia, 31217, United States
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Newnan, Georgia, 30265, United States
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Honolulu, Hawaii, 96817, United States
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Meridian, Idaho, 83642, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60616, United States
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Chicago, Illinois, 60637, United States
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Evanston, Illinois, 60201, United States
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Peoria, Illinois, 61603, United States
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Quincy, Illinois, 62301, United States
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Columbus, Indiana, 47201, United States
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Michigan City, Indiana, 46360, United States
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Ames, Iowa, 50010, United States
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Kansas City, Kansas, 66160, United States
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Wichita, Kansas, 67214-2998, United States
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Lexington, Kentucky, 40504, United States
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Paducah, Kentucky, 42003, United States
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Baton Rouge, Louisiana, 70808, United States
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Lafayette, Louisiana, 70503, United States
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Metairie, Louisiana, 70006, United States
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Natchitoches, Louisiana, 71457, United States
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New Orleans, Louisiana, 70112, United States
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Ruston, Louisiana, 71270, United States
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Shreveport, Louisiana, 71101, United States
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Rockport, Maine, 04856, United States
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Bethesda, Maryland, 20814, United States
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Oxon Hill, Maryland, 20745, United States
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Framingham, Massachusetts, 01702, United States
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Plymouth, Massachusetts, 02360, United States
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Springfield, Massachusetts, 01107, United States
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Flint, Michigan, 48504, United States
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Grand Rapids, Michigan, 49525, United States
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Kalamazoo, Michigan, 49007, United States
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Midland, Michigan, 48640, United States
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Pontiac, Michigan, 48341, United States
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Royal Oak, Michigan, 48073, United States
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Southgate, Michigan, 48195, United States
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Columbus, Mississippi, 39705, United States
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Gulfport, Mississippi, 39501, United States
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City of Saint Peters, Missouri, 63376, United States
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Kansas City, Missouri, 64111, United States
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Kansas City, Missouri, 64114, United States
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Lincoln, Nebraska, 68510, United States
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North Platte, Nebraska, 69101, United States
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Henderson, Nevada, 89052, United States
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Las Vegas, Nevada, 89106, United States
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Eatontown, New Jersey, 07724, United States
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Livingston, New Jersey, 07039, United States
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Toms River, New Jersey, 08755, United States
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Voorhees Township, New Jersey, 08043, United States
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Albany, New York, 12208, United States
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Brooklyn, New York, 11203, United States
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Buffalo, New York, 14215, United States
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Flushing, New York, 11355, United States
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Great Neck, New York, 11021, United States
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Mineola, New York, 11501, United States
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New York, New York, 10037, United States
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Orchard Park, New York, 14127, United States
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Rochester, New York, 14642, United States
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Rosedale, New York, 11422, United States
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The Bronx, New York, 10461, United States
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Asheville, North Carolina, 28801, United States
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Chapel Hill, North Carolina, 27599, United States
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Durham, North Carolina, 27704, United States
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Greensboro, North Carolina, 27408, United States
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Greenville, North Carolina, 27834, United States
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Kinston, North Carolina, 28504, United States
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Mooresville, North Carolina, 28117, United States
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New Bern, North Carolina, 28562, United States
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Statesville, North Carolina, 28625, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
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Winston-Salem, North Carolina, 27157, United States
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Fargo, North Dakota, 58103, United States
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Fargo, North Dakota, 58122, United States
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Grand Forks, North Dakota, 58201, United States
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Columbus, Ohio, 43210, United States
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Columbus, Ohio, 43215, United States
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Marion, Ohio, 43302, United States
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Poland, Ohio, 44514, United States
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Toledo, Ohio, 43606, United States
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Willoughby Hills, Ohio, 44094, United States
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Oklahoma City, Oklahoma, 73116, United States
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Tulsa, Oklahoma, 74120, United States
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Portland, Oregon, 97210, United States
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Portland, Oregon, 97213, United States
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Roseburg, Oregon, 97471, United States
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Beaver, Pennsylvania, 15009, United States
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Bethlehem, Pennsylvania, 18017, United States
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Doylestown, Pennsylvania, 18901, United States
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Duncansville, Pennsylvania, 16635, United States
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Philadelphia, Pennsylvania, 19102, United States
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Philadelphia, Pennsylvania, 19118, United States
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Philadelphia, Pennsylvania, 19140, United States
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Anderson, South Carolina, 29621, United States
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Columbia, South Carolina, 29203, United States
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Greenville, South Carolina, 29605, United States
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Orangeburg, South Carolina, 29118, United States
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Bristol, Tennessee, 37620, United States
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Columbia, Tennessee, 38401, United States
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Dyersburg, Tennessee, 38024, United States
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Franklin, Tennessee, 37064, United States
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Jackson, Tennessee, 38305, United States
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Kingsport, Tennessee, 37660, United States
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Knoxville, Tennessee, 37923, United States
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Memphis, Tennessee, 38163, United States
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Arlington, Texas, 76015, United States
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Austin, Texas, 78705, United States
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Austin, Texas, 78751, United States
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Austin, Texas, 78758, United States
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Corsicana, Texas, 75110, United States
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Dallas, Texas, 75390, United States
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Edinburg, Texas, 78539, United States
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El Paso, Texas, 79905, United States
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Fort Worth, Texas, 76104, United States
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Frisco, Texas, 75035, United States
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Greenville, Texas, 75402, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77008, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77031, United States
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Houston, Texas, 77036, United States
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Houston, Texas, 77054, United States
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Houston, Texas, 77057, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77099, United States
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Lubbock, Texas, 79430, United States
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Lufkin, Texas, 75904, United States
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McAllen, Texas, 78503, United States
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McKinney, Texas, 75069, United States
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San Antonio, Texas, 78205, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78224, United States
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San Antonio, Texas, 78228, United States
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San Antonio, Texas, 78229, United States
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Temple, Texas, 76502, United States
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Burlington, Vermont, 05401, United States
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Alexandria, Virginia, 22304, United States
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Chesapeake, Virginia, 23320, United States
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Fairfax, Virginia, 22030, United States
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Fairfax, Virginia, 22033, United States
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Hampton, Virginia, 23666, United States
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Manassas, Virginia, 20110, United States
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Mechanicsville, Virginia, 23116, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23219, United States
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Richmond, Virginia, 23229, United States
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Richmond, Virginia, 23298-0160, United States
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Silverdale, Washington, 98383, United States
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Bluefield, West Virginia, 24701, United States
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Milwaukee, Wisconsin, 53226, United States
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Caguas, 00725, Puerto Rico
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Ponce, 00716, Puerto Rico
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Ponce, 00717, Puerto Rico
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Rio Piedras, 00935, Puerto Rico
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San Juan, 00909, Puerto Rico
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San Juan, 00918, Puerto Rico
Related Publications (1)
Toto R, Petersen J, Berns JS, Lewis EF, Tran Q, Weir MR. A Randomized Trial of Strategies Using Darbepoetin Alfa To Avoid Transfusions in CKD. J Am Soc Nephrol. 2021 Feb;32(2):469-478. doi: 10.1681/ASN.2020050556. Epub 2020 Dec 7.
PMID: 33288629BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2012
First Posted
July 30, 2012
Study Start
July 30, 2012
Primary Completion
October 19, 2017
Study Completion
October 19, 2017
Last Updated
September 21, 2022
Results First Posted
November 8, 2018
Record last verified: 2022-09