Clinical trial NCT00238043: Cohort Study to Determine the Long-Term Safety and Efficacy of Biogeneric Epoetin Treatment for Renal Anemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Kidney Disease
End-Stage Renal Failure
Anaemia
Keywords: Biogeneric Epoetin treatment
Renal anaemia
Chronic Kidney Disease
Pure Red Blood Cell Aplasia
Hemodialysis
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
First posted: 2005-10-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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.

Primary outcomes:
measure: 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:
measure: Mortality, quality of life and cost during the 6 years study treatment.
Other outcomes:
Locations:
city: Kuantan
country: Malaysia
facility: Pahang Buddhist Association
state: Pahang
city: Kuantan
country: Malaysia
facility: Pusat Hemodialisis Islam Makmur
state: Pahang
city: Klang
country: Malaysia
facility: SP Menon Dialysis Centre
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Tan Medical Renal Clinic
state: Selangor
city: PJ
country: Malaysia
facility: SP Menon Dialysis Centre
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Klinik Pakar Dialysis
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Sunway Medical Centre
state: Selangor
city: KL
country: Malaysia
facility: The Kidney Dialysis Centre
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Aiman Dialysis Centre
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Ampang Putri Specialist Hospital
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Cheras Dialysis Centre
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Gleneagles Intan Medical Centre
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Pantai Medical Centre
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Smartcare Dialysis Centre
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: The Kidney Dialysis Centre
state: Wilayah Persekutuan
Study officials:
affiliation: Department of Nephrology, Kuala Lumpur Hospital
name: Dato' Dr. Zaki Morad Mohamad Zaher, MRCP, FRCP
role: PRINCIPAL_INVESTIGATOR
References: