Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis

NCT00434330 | Completed Phase 2 Results

• 2 other identifiers: AFX01-072006-002815-28
• Study Type: interventional
• Target: 91
• Locations: 3 countries
• Sites: 15

Brief Summary

The purpose of this study was to determine the dose ranges of peginesatide administered intravenously or subcutaneously that maintained hemoglobin in participants on dialysis whose hemoglobin values were stable on epoetin (alfa or beta).

Conditions

Anemia; Chronic Kidney Disease; Chronic Renal Failure

Keywords

anemia; chronic kidney disease; CKD; chronic renal failure; CRF; dialysis; erythropoietin; EPO; erythropoiesis stimulating agent; ESA; Hematide™; hemodialysis; hemoglobin; Hb; Hgb; Omontys; peginesatide; red blood cell; red blood cell production

Outcome Measures

Primary Outcomes (1)

• Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial.

  The Baseline hemoglobin was the mean of the four most recent mid- or end-of-week predialysis hemoglobin values collected prior to study start. Study start was the date of the first dose of peginesatide injection in participants who did not have a one-week transition period, or the date when Epoetin treatment was first withheld in participants who did have a one-week transition period.

  Baseline and Weeks 2-29

Other Outcomes (3)

• Proportion of Participants With Hemoglobin Within 1.0 g/dL Below Baseline to 1.5 g/dL Above Baseline Throughout the Trial (Weeks 2-29)

  Weeks 2 to 29

• Proportion of Participants Who Maintained Hemoglobin Within 10 to 12.5 g/dL Throughout the Trial

  Weeks 2 to 29

• Proportion of Participants Who Maintain Hemoglobin Within 9.5 to 13.0 g/dL Throughout the Trial

  Weeks 2 to 29

Study Arms (6)

Cohort 1, Q4W, SC, No Transition

EXPERIMENTAL

Drug: peginesatide

Cohort 2, Q4W, IV, No Transition

EXPERIMENTAL

Drug: peginesatide

Cohort 3, Q4W, SC, Transition

EXPERIMENTAL

Drug: peginesatide

Cohort 4, Q4W, IV, Transition

EXPERIMENTAL

Drug: peginesatide

Cohort 5, Q4W, SC, Transition

EXPERIMENTAL

Drug: peginesatide

Cohort 6, Q4W, IV, Transition

EXPERIMENTAL

Drug: peginesatide

Interventions

peginesatide DRUG

Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.

Also known as: Omontys, Hematide, AF37702 Injection

Cohort 1, Q4W, SC, No Transition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines
• Males or females ≥ 18 years of age. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 4 weeks prior to study start, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug
• Clinically stable on hemodialysis for ≥ 3 months prior to study start
• Epoetin (alfa or beta) maintenance therapy, ≥ 50 and ≤ 200 Units/kg/week, at the same dosing frequency, continuously prescribed for 8 weeks prior to study start
• Three mid- or end-of-week hemoglobin values of ≥ 10.0 and ≤ 12.5 grams per deciliter (g/dL) in the 4 weeks prior to study start, with ≤ 1.2 g/dL difference between any of the three values
• One transferrin saturation (TSAT) \> 20% within 4 weeks prior to study start
• One ferritin level ≥ 100 ng/mL within 4 weeks prior to study start
• One serum or red cell folate level ≥ lower limit of normal during the 4 weeks prior to study start
• One vitamin B12 level ≥ lower limit of normal during the 4 weeks prior to study start
• One C-reactive protein (CRP) level ≤ 30 mg/L within 4 weeks prior to study start
• Urea clearance/volume (Kt/V) ≥ 1.2 within 4 weeks prior to study start
• One white blood cell count (WBC) ≥ 3.0 x 10\^9/L within 4 weeks prior to study start
• One platelet count ≥ 100 x 10\^9/L and ≤ 500 x 10\^9/L within 4 weeks prior to study start

You may not qualify if:

• Pregnant or breast-feeding participants
• Known intolerance to any erythropoiesis stimulating agent, parenteral iron supplementation or pegylated molecules
• History of antibodies to any erythropoiesis stimulating agent or history of pure red cell aplasia (PRCA)
• Known bleeding or coagulation disorder
• Known hematologic disease (e.g., homozygous sickle-cell disease, thalassemia of all types, multiple myeloma, hemolytic anemia)
• Uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.)
• Known history of seizure disorder or received anti-epileptic medication within the previous 6 months
• Uncontrolled or symptomatic secondary hyperparathyroidism, per Investigator's clinical judgment
• Poorly controlled hypertension within 4 weeks prior to study start, per Investigator's clinical judgment
• Chronic congestive heart failure of New York Heart Association class III or IV
• High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric, or neurological abnormalities, liver disease including active hepatitis B or C, active HIV disease, or any other clinically significant medical diseases or conditions in the prior 6 months that may, in the Investigator's opinion, interfere with safety, assessment, or follow-up of the participant)
• Life expectancy \< 12 months
• Temporary (untunneled) dialysis access catheter
• Anticipated elective surgery during the study period, that may be expected to lead to significant blood loss, including vascular access surgery such as an arteriovenous fistula or graft, or a scheduled kidney transplant
• Red blood cell or whole blood transfusion within 12 weeks prior to study start

Sponsors & Collaborators

• Affymax: lead

Study Sites (15)

Research Facility

Burgas, 8000, Bulgaria

Location

Research Facility

Pleven, 5800, Bulgaria

Location

Research Facility

Plovdiv, 4003, Bulgaria

Location

Research Facility

Rousse, 7002, Bulgaria

Location

Research Facility

Sofia, 1527, Bulgaria

Location

Research Facility

Sofia, 1606, Bulgaria

Location

Research Facility

Sofia, 1709, Bulgaria

Location

Research Facility

Varna, 9010, Bulgaria

Location

Research Facility

Veliko Tarnovo, 5000, Bulgaria

Location

Research Facility

Arad, 310017, Romania

Location

Research Facility

Bacau, 600114, Romania

Location

Research Facility

Bucharest, Romania

Location

Research Facility

Iași, 700503, Romania

Location

Research Facility

Timișoara, 300736, Romania

Location

Research Facility

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

peginesatide; hematide

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Notable issues with some documentation occurred at some of the study sites. In general, overall results excluding the sites with issues were comparable to results based on the full population.

Results Point of Contact

• Title: Vice President, Clinical Development
• Organization: Affymax

info@affymax.com

650-812-8700

Study Officials

• Vice President, Clinical Development

  Affymax, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2007
• First Posted: February 13, 2007
• Study Start: December 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 29, 2012
• Results First Posted: May 28, 2012

Record last verified: 2012-06

Locations

BU (9); GB (1); RO (5)