Clinical trial NCT00093015: Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT)
Official title: Trial to Reduce Cardiovascular Events With Aranesp® Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Disease
Diabetes Mellitus
Anemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-09-29
Enrollment: 4038
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

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

Primary outcomes:
measure: 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)
timeFrame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first
measure: Time to All-cause Mortality or End Stage Renal Disease (ESRD)
timeFrame: 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:
measure: Time to All-cause Mortality
timeFrame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first
measure: Time to Cardiovascular Mortality
timeFrame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first
measure: Time to Myocardial Infarction
timeFrame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first
measure: Time to Cerebrovascular Accident
timeFrame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first
measure: Time to Congestive Heart Failure
timeFrame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first
measure: Time to End Stage Renal Disease
timeFrame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first
measure: Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) Relative to Baseline
timeFrame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first
measure: Change in Patient Reported Fatigue Relative to Baseline at Week 25
timeFrame: Baseline and week 25
measure: Time to Hospitalization Due to Acute Myocardial Ischemia
timeFrame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.