Phase 3 Completed N=4,038 Randomized Quadruple-blind Treatment

Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT)

Chronic Kidney Disease · Diabetes · Anemia

Source: ClinicalTrials.gov NCT00093015 ↗

Enrolled (actual)

4,038

Serious AEs

61.0%

Results posted

Sep 2010

Primary outcomePrimary: 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) — 602; 632 Participants — p=0.41

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

Outcome Measures

Outcome	Result	p-value
PRIMARY 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)	602; 632	0.41
PRIMARY Time to All-cause Mortality or End Stage Renal Disease (ESRD)	618; 652	0.29
SECONDARY Time to All-cause Mortality	395; 412	0.48
SECONDARY Time to Cardiovascular Mortality	250; 259	0.61
SECONDARY Time to Myocardial Infarction	129; 124	0.73
SECONDARY Time to Cerebrovascular Accident	53; 101	<0.001 sig
SECONDARY Time to Congestive Heart Failure	229; 205	0.24
SECONDARY Time to End Stage Renal Disease	330; 338	0.83
SECONDARY Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) Relative to Baseline	-1.89; -1.30	0.54
SECONDARY Change in Patient Reported Fatigue Relative to Baseline at Week 25	2.8; 4.2	<0.001 sig
SECONDARY Time to Hospitalization Due to Acute Myocardial Ischemia	49; 41	0.40

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00093015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.