Cohort Study to Determine the Long-Term Safety and Efficacy of Biogeneric Epoetin Treatment for Renal Anemia

NCT00238043 Phase 3 UNKNOWN

The purpose of this study is to establish the long-term safety and efficacy of Biogeneric Epoetin, the attainability of therapeutic target for anaemia management, and the impact of Epoetin treatment on long-term health outcome and its cost effectiveness.

Details

Lead sponsor	Ministry of Health, Malaysia
Phase	Phase 3
Status	UNKNOWN
Enrolment	2000
Start date	2005-08
Completion	2011-04

Conditions

• Chronic Kidney Disease
• End-Stage Renal Failure
• Anaemia

Interventions

• Biogeneric Epoetin

Primary outcomes

• To investigate the Hb levels at each every 3 months follow up visit and the incidence of lack anticipated Hb response or loss of response to Biogeneric Epoetin. To monitor the occurrence of PRCA and other immunogenicity related adverse event.

Countries

Malaysia