NCT00093015

Brief Summary

The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular events, and (2) progression to end-stage renal disease or death, in subjects with chronic kidney disease and type 2 diabetes mellitus. Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,038

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2004

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 2, 2010

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

4.6 years

First QC Date

September 28, 2004

Results QC Date

August 6, 2010

Last Update Submit

November 4, 2022

Conditions

Kidney DiseaseDiabetes MellitusAnemia

Outcome Measures

Primary Outcomes (2)

  • Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)

    Time from randomization to the first confirmed composite event. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.

    Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first

  • Time to All-cause Mortality or End Stage Renal Disease (ESRD)

    Time from randomization to first event of all-cause mortality or ESRD. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.

    Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first

Secondary Outcomes (9)

  • Time to All-cause Mortality

    Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first

  • Time to Cardiovascular Mortality

    Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first

  • Time to Myocardial Infarction

    Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first

  • Time to Cerebrovascular Accident

    Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first

  • Time to Congestive Heart Failure

    Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first

  • +4 more secondary outcomes

Study Arms (2)

Active

ACTIVE COMPARATOR
Drug: darbepoetin alfa

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

Volume and dose frequency changes resembling dosing in the active treatment group

Placebo
darbepoetin alfaDRUG

Starting dose : 0.75 mcg/kg subcutaneous (SC) every two weeks (Q2W); subsequent doses titrated to achieve hemoglobin (Hb) target of 13.0 g/dL

Active

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemoglobin less than or equal to 11 g/dL
  • History of Chronic Kidney Disease
  • eGFR (estimated glomerular filtration rate) greater than or equal to 20 mL/min/1.73 m2 and less than or equal to 60 mL/min/1.73 m2
  • Tsat (transferrin saturation) greater than 15%

You may not qualify if:

  • Uncontrolled hypertension
  • Erythropoietic protein use within 12 weeks of randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Lewis EF, Pfeffer MA, Feng A, Uno H, McMurray JJ, Toto R, Gandra SR, Solomon SD, Moustafa M, Macdougall IC, Locatelli F, Parfrey PS; TREAT Investigators. Darbepoetin alfa impact on health status in diabetes patients with kidney disease: a randomized trial. Clin J Am Soc Nephrol. 2011 Apr;6(4):845-55. doi: 10.2215/CJN.06450710. Epub 2011 Jan 6.

    PMID: 21212421BACKGROUND

  • McMurray JJ, Uno H, Jarolim P, Desai AS, de Zeeuw D, Eckardt KU, Ivanovich P, Levey AS, Lewis EF, McGill JB, Parfrey P, Parving HH, Toto RM, Solomon SD, Pfeffer MA. Predictors of fatal and nonfatal cardiovascular events in patients with type 2 diabetes mellitus, chronic kidney disease, and anemia: an analysis of the Trial to Reduce cardiovascular Events with Aranesp (darbepoetin-alfa) Therapy (TREAT). Am Heart J. 2011 Oct;162(4):748-755.e3. doi: 10.1016/j.ahj.2011.07.016.

    PMID: 21982669BACKGROUND

  • Mix TC, Brenner RM, Cooper ME, de Zeeuw D, Ivanovich P, Levey AS, McGill JB, McMurray JJ, Parfrey PS, Parving HH, Pereira BJ, Remuzzi G, Singh AK, Solomon SD, Stehman-Breen C, Toto RD, Pfeffer MA. Rationale--Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): evolving the management of cardiovascular risk in patients with chronic kidney disease. Am Heart J. 2005 Mar;149(3):408-13. doi: 10.1016/j.ahj.2004.09.047.

    PMID: 15864229BACKGROUND

  • Pfeffer MA, Burdmann EA, Chen CY, Cooper ME, de Zeeuw D, Eckardt KU, Feyzi JM, Ivanovich P, Kewalramani R, Levey AS, Lewis EF, McGill JB, McMurray JJ, Parfrey P, Parving HH, Remuzzi G, Singh AK, Solomon SD, Toto R; TREAT Investigators. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med. 2009 Nov 19;361(21):2019-32. doi: 10.1056/NEJMoa0907845. Epub 2009 Oct 30.

    PMID: 19880844BACKGROUND

  • Solomon SD, Uno H, Lewis EF, Eckardt KU, Lin J, Burdmann EA, de Zeeuw D, Ivanovich P, Levey AS, Parfrey P, Remuzzi G, Singh AK, Toto R, Huang F, Rossert J, McMurray JJ, Pfeffer MA; Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) Investigators. Erythropoietic response and outcomes in kidney disease and type 2 diabetes. N Engl J Med. 2010 Sep 16;363(12):1146-55. doi: 10.1056/NEJMoa1005109.

    PMID: 20843249BACKGROUND

  • Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

    PMID: 37651553DERIVED

  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

    PMID: 36791280DERIVED

  • Lewis EF, Claggett B, Parfrey PS, Burdmann EA, McMurray JJ, Solomon SD, Levey AS, Ivanovich P, Eckardt KU, Kewalramani R, Toto R, Pfeffer MA. Race and ethnicity influences on cardiovascular and renal events in patients with diabetes mellitus. Am Heart J. 2015 Aug;170(2):322-9. doi: 10.1016/j.ahj.2015.05.008. Epub 2015 May 22.

    PMID: 26299230DERIVED

  • Bello NA, Pfeffer MA, Skali H, McGill JB, Rossert J, Olson KA, Weinrauch L, Cooper ME, de Zeeuw D, Rossing P, McMurray JJ, Solomon SD. Retinopathy and clinical outcomes in patients with type 2 diabetes mellitus, chronic kidney disease, and anemia. BMJ Open Diabetes Res Care. 2014 Apr 6;2(1):e000011. doi: 10.1136/bmjdrc-2013-000011. eCollection 2014.

    PMID: 25452859DERIVED

  • Skali H, Parving HH, Parfrey PS, Burdmann EA, Lewis EF, Ivanovich P, Keithi-Reddy SR, McGill JB, McMurray JJ, Singh AK, Solomon SD, Uno H, Pfeffer MA; TREAT Investigators. Stroke in patients with type 2 diabetes mellitus, chronic kidney disease, and anemia treated with Darbepoetin Alfa: the trial to reduce cardiovascular events with Aranesp therapy (TREAT) experience. Circulation. 2011 Dec 20;124(25):2903-8. doi: 10.1161/CIRCULATIONAHA.111.030411. Epub 2011 Nov 21.

    PMID: 22104547DERIVED

  • Pfeffer MA, Burdmann EA, Chen CY, Cooper ME, de Zeeuw D, Eckardt KU, Ivanovich P, Kewalramani R, Levey AS, Lewis EF, McGill J, McMurray JJ, Parfrey P, Parving HH, Remuzzi G, Singh AK, Solomon SD, Toto R, Uno H; TREAT Investigators. Baseline characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). Am J Kidney Dis. 2009 Jul;54(1):59-69. doi: 10.1053/j.ajkd.2009.04.008. Epub 2009 Jun 5.

    PMID: 19501439DERIVED

  • Pfeffer MA; TREAT Executive Committee. An ongoing study of anemia correction in chronic kidney disease. N Engl J Med. 2007 Mar 1;356(9):959-61. doi: 10.1056/NEJMc066568. No abstract available.

    PMID: 17329707DERIVED

Related Links

MeSH Terms

Conditions

Kidney DiseasesDiabetes MellitusAnemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Limitations and Caveats

4047 subjects were enrolled, but before unblinding, all information from 9 subjects was excluded from two sites (3 and 6 subjects, respectively) that did not adhere to Good Clinical Practice guidelines. 4038 subjects were analyzed and reported.

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2004

First Posted

September 29, 2004

Study Start

August 1, 2004

Primary Completion

March 1, 2009

Study Completion

July 1, 2009

Last Updated

November 8, 2022

Results First Posted

September 2, 2010

Record last verified: 2022-11