NCT00093015

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

Trial to Reduce Cardiovascular Events With Aranesp® Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,038 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Kidney Disease
• Diabetes Mellitus
• Anemia

Interventions

Type	Name	Description
DRUG	Placebo	Volume and dose frequency changes resembling dosing in the active treatment group
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

Timeline

• Start date: 2004-08-01
• Primary completion: 2009-03-01
• Completion: 2009-07-01
• First posted: 2004-09-29
• Last updated: 2022-11-08
• Results posted: 2010-09-02