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

Amgen

Status and phase: Completed; Phase 3

Conditions: Anemia; Diabetes Mellitus; Kidney Disease

Treatments: Drug: darbepoetin alfa; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00093015

TREAT

20010184

Details and patient eligibility

About

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

Enrollment: 4,038 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,038 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Treatment:

Drug: darbepoetin alfa

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo