Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

2,000

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Aug 2005

Longer than P75 for phase_3

Geographic Reach

1 country

14 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.7 years study duration

Study Start

First participant enrolled

August 1, 2005

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed

5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed

Last Updated

June 17, 2008

Status Verified

October 1, 2005

First QC Date

October 12, 2005

Last Update Submit

June 12, 2008

Conditions

Chronic Kidney Disease End-Stage Renal Failure Anaemia

Keywords

Biogeneric Epoetin treatmentRenal anaemiaChronic Kidney DiseasePure Red Blood Cell AplasiaHemodialysis

Outcome Measures

Primary Outcomes (1)

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.

Secondary Outcomes (1)

Mortality, quality of life and cost during the 6 years study treatment.

Interventions

Biogeneric EpoetinDRUG

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient who has Chronic Kidney Disease with anaemia for which Epoetin treatment is indicated.
Patient without known hypersensitivity to the mammalian cell-derived product or human albumin products.

Contact the study team to confirm eligibility.