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NCT00238043 Clinical Trial

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

Chronic Kidney Disease Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00238043
Other study ID # CT 05-17
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received October 12, 2005
Last updated June 12, 2008
Start date August 2005
Est. completion date April 2011

Study information
Verified date October 2005
Source Ministry of Health, Malaysia
Contact n/a
Is FDA regulated No
Health authority Malaysia: Ministry of Health
Study type Interventional

Clinical Trial 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.

Description:

This study protocol is an elaboration of the original study protocol titled "A Randomized, Multi-center, Open label trial to establish the therapeutic equivalence between Biogeneric Epoetin and Eprex and to determine the long term safety profile of Biogeneric Epoetin in patients on Hemodialysis".

In the first stage, a biogeneric Epoetin shall be evaluated by a randomized trial designed to demonstrate therapeutic equivalence (TE) versus an innovator product (Eprex), the efficacy clinical end-point being Hb at 6 to 12 weeks on treatment.

When preliminary evidence of efficacy is established from above stage 1 TE trial, the product may proceed to be evaluated in a stage 2 single group cohort study designed to establish the long term safety, with particular emphasis on surveillance for occurrence of Pure Red Cell Aplasia (PRCA) and other immunogenicity related adverse event. To establish the long term efficacy, its emphasis on the potential impact of batch to batch variation in product content and potency (bioactivity) on Hb response.

This practical trial also designed to investigate the cost-effectiveness by estimating the optimal dosage for combination of Epoetin and Iron sucrose to achieve Hb target under unconstrained prescriptionas, and hence the budgetary requirement can be estimated to meet therapeutic target in this dialysis population under various pricing scenario in the presence of generic competition.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2000
Est. completion date April 2011
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Biogeneric Epoetin

Locations
Country Name City State
Malaysia The Kidney Dialysis Centre KL Wilayah Persekutuan
Malaysia SP Menon Dialysis Centre Klang Selangor
Malaysia Aiman Dialysis Centre Kuala Lumpur Wilayah Persekutuan
Malaysia Ampang Putri Specialist Hospital Kuala Lumpur Wilayah Persekutuan
Malaysia Cheras Dialysis Centre Kuala Lumpur Wilayah Persekutuan
Malaysia Gleneagles Intan Medical Centre Kuala Lumpur Wilayah Persekutuan
Malaysia Pantai Medical Centre Kuala Lumpur Wilayah Persekutuan
Malaysia Smartcare Dialysis Centre Kuala Lumpur Wilayah Persekutuan
Malaysia The Kidney Dialysis Centre Kuala Lumpur Wilayah Persekutuan
Malaysia Pahang Buddhist Association Kuantan Pahang
Malaysia Pusat Hemodialisis Islam Makmur Kuantan Pahang
Malaysia Tan Medical Renal Clinic Petaling Jaya Selangor
Malaysia SP Menon Dialysis Centre PJ Selangor
Malaysia Klinik Pakar Dialysis Subang Jaya Selangor
Malaysia Sunway Medical Centre Subang Jaya Selangor

Sponsors (1)
Lead Sponsor Collaborator
Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Mortality, quality of life and cost during the 6 years study treatment.
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