Trial intelligence / Profile preview

TREAT: Aranesp in CKD and Type 2 Diabetes

NCT00093015Phase 3

Key facts

Status: Completed
Start: Aug 2004
Primary completion: Mar 2009
Sponsor: Amgen
Modality: Erythropoietins, Colony Stimulating Factors

Drugs: darbepoetin alfa
Conditions: anemia

Overview

Phase 3, randomised, double-blind trial of darbepoetin alfa in anemia (2 arms), sponsored by Amgen. Primary endpoints: Time to All-cause Mortality or Cardiovascular (CV) Events and Time to All-cause Mortality or End Stage Renal Disease (ESRD). Started Aug 2004; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Active
Darbepoetin alfa 0.75 mcg/kg Q2W titrated to Hb 13.0 g/dL
Placebo
Placebo matching dosing frequency

Endpoints

Primary

Time to All-cause Mortality or Cardiovascular (CV) EventsUntil event or 28 March 2009
Time to All-cause Mortality or End Stage Renal Disease (ESRD)Until event or 28 March 2009

Secondary

Time to All-cause MortalityUntil event or 28 March 2009
Time to Cardiovascular MortalityUntil event or 28 March 2009
Time to Myocardial InfarctionUntil event or 28 March 2009
Time to Cerebrovascular AccidentUntil event or 28 March 2009
Time to Congestive Heart FailureUntil event or 28 March 2009
Time to End Stage Renal DiseaseUntil event or 28 March 2009
Rate of Decline in Estimated Glomerular Filtration Rate (eGFR)Until event or 28 March 2009
Change in Patient Reported FatigueWeek 25

Results

Not all primary endpoints met

Beyond the preview

Go deeper on NCT00093015.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00093015.