Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Ministry of Health, Malaysia |
---|---|
Information provided by: | Ministry of Health, Malaysia |
ClinicalTrials.gov Identifier: | NCT00238043 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Kidney Disease End-Stage Renal Failure Anaemia |
Drug: Biogeneric Epoetin |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 2000 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | April 2011 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Malaysia, Pahang | |
Pusat Hemodialisis Islam Makmur | |
Kuantan, Pahang, Malaysia | |
Pahang Buddhist Association | |
Kuantan, Pahang, Malaysia | |
Malaysia, Selangor | |
SP Menon Dialysis Centre | |
PJ, Selangor, Malaysia | |
Tan Medical Renal Clinic | |
Petaling Jaya, Selangor, Malaysia | |
SP Menon Dialysis Centre | |
Klang, Selangor, Malaysia | |
Sunway Medical Centre | |
Subang Jaya, Selangor, Malaysia | |
Klinik Pakar Dialysis | |
Subang Jaya, Selangor, Malaysia | |
Malaysia, Wilayah Persekutuan | |
Aiman Dialysis Centre | |
Kuala Lumpur, Wilayah Persekutuan, Malaysia | |
The Kidney Dialysis Centre | |
Kuala Lumpur, Wilayah Persekutuan, Malaysia | |
Gleneagles Intan Medical Centre | |
Kuala Lumpur, Wilayah Persekutuan, Malaysia | |
Cheras Dialysis Centre | |
Kuala Lumpur, Wilayah Persekutuan, Malaysia | |
Smartcare Dialysis Centre | |
Kuala Lumpur, Wilayah Persekutuan, Malaysia | |
Ampang Putri Specialist Hospital | |
Kuala Lumpur, Wilayah Persekutuan, Malaysia | |
Pantai Medical Centre | |
Kuala Lumpur, Wilayah Persekutuan, Malaysia | |
The Kidney Dialysis Centre | |
KL, Wilayah Persekutuan, Malaysia |
Principal Investigator: | Dato' Dr. Zaki Morad Mohamad Zaher, MRCP, FRCP | Department of Nephrology, Kuala Lumpur Hospital |
Study ID Numbers: | CT 05-17 |
Study First Received: | October 12, 2005 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00238043 History of Changes |
Health Authority: | Malaysia: Ministry of Health |
Biogeneric Epoetin treatment Renal anaemia Chronic Kidney Disease Pure Red Blood Cell Aplasia Hemodialysis |
Epoetin Alfa Renal Insufficiency Urologic Diseases Hematologic Diseases Renal Insufficiency, Chronic |
Anemia Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Renal Insufficiency Urologic Diseases Hematologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Anemia Kidney Diseases Kidney Failure |