Study Complete
Sponsor ID
20030237

Study for Subjects with Chronic Kidney Disease(CKD) Not Receiving Dialysis

Sponsor ID
20030237
Clinicaltrials.gov ID
NCT00112008
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The proposed study is designed to test a novel dosing paradigm

that would facilitate the treatment of anemia in CKD patients not on

dialysis. Anemic patients who are not currently receiving ESA therapy will be dosed with darbepoetin alfa Q2W for 18 weeks.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
None (Open Label)
Enrollment
100
Additional Study Details

Protocol Summary

Primary Outcome Measures

The proportion of subjects achieving a Hb ≥ 11.0 g/dL

Timeframe: Entire Study

Secondary Outcome Measures

Hb values over the duration of the study

Timeframe: Entire Study

Darbepoetin alfa doses over the duration of the study

Timeframe: Entire Study

Frequency, severity, and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure

Timeframe: Entire Study

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.