Study to Assess Darbepoetin Alfa in Subjects with Chronic Kidney Disease

Sponsor ID

20040180

Clinicaltrials.gov ID

NCT00093977

EUCTIS ID

N/A

EudraCT ID

N/A

Study Details

The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.

Additional Study Details

Phase

Phase 3

Product

darbepoetin alfa

Type

Interventional

Masking

None (Open Label)

Enrollment

1100

Additional Study Details

Protocol Summary

Primary Outcome Measures

To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile

Timeframe: Entire Study

Secondary Outcome Measures

To characterize laboratory parameters in subjects with CKD

Timeframe: Entire Study

Study Documents

Study Synopsis

Available Language(s): English

Download Document(s)

Locations

No locations found.