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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4038 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-01

Study Completion Date

2009-07-01

Brief Summary

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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

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Detailed Description

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Conditions

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Kidney Disease Diabetes Mellitus Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

Group Type ACTIVE_COMPARATOR

darbepoetin alfa

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

darbepoetin alfa

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

Intervention Type DRUG

Eligibility Criteria

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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%