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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Ministry of Health, Malaysia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ministry of Health, Malaysia
ClinicalTrials.gov Identifier:
NCT00238043
First received: October 12, 2005
Last updated: June 12, 2008
Last verified: October 2005
  Purpose

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 3

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

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Malaysia:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Mortality, quality of life and cost during the 6 years study treatment.

Estimated Enrollment: 2000
Study Start Date: August 2005
Estimated Study Completion Date: April 2011
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238043

Locations
Malaysia
Pusat Hemodialisis Islam Makmur
Kuantan, Pahang, Malaysia
Pahang Buddhist Association
Kuantan, Pahang, Malaysia
SP Menon Dialysis Centre
Klang, Selangor, Malaysia
Tan Medical Renal Clinic
Petaling Jaya, Selangor, Malaysia
SP Menon Dialysis Centre
PJ, Selangor, Malaysia
Sunway Medical Centre
Subang Jaya, Selangor, Malaysia
Klinik Pakar Dialysis
Subang Jaya, Selangor, Malaysia
The Kidney Dialysis Centre
KL, 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
Aiman Dialysis Centre
Kuala Lumpur, Wilayah Persekutuan, Malaysia
Sponsors and Collaborators
Ministry of Health, Malaysia
Investigators
Principal Investigator: Dato' Dr. Zaki Morad Mohamad Zaher, MRCP, FRCP Department of Nephrology, Kuala Lumpur Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00238043     History of Changes
Other Study ID Numbers: CT 05-17
Study First Received: October 12, 2005
Last Updated: June 12, 2008
Health Authority: Malaysia: Ministry of Health

Keywords provided by Ministry of Health, Malaysia:
Biogeneric Epoetin treatment
Renal anaemia
Chronic Kidney Disease
Pure Red Blood Cell Aplasia
Hemodialysis

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014