Chronic Kidney DiseasePhase 3NCT00238043
Cohort Study to Determine the Long-Term Safety and Efficacy of Biogeneric Epoetin Treatment for Renal Anemia
A Phase 3 study testing Biogeneric Epoetin in people with Chronic Kidney Disease and End-Stage Renal Failure, run by Ministry of Health, Malaysia at 14 sites in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, End-Stage Renal Failure, Anaemia
- What is being tested?
- Biogeneric Epoetin
- How many people
- 2,000 participants
- Where
- 14 sitesMalaysia
- Study dates
- Aug 2005to Apr 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Malaysia14 sites
SP Menon Dialysis Centre
Klang, Selangor
Aiman Dialysis Centre
Kuala Lumpur, Kuala Lumpur
Ampang Putri Specialist Hospital
Kuala Lumpur, Kuala Lumpur
Cheras Dialysis Centre
Kuala Lumpur, Kuala Lumpur
Gleneagles Intan Medical Centre
Kuala Lumpur, Kuala Lumpur
Pantai Medical Centre
Kuala Lumpur, Kuala Lumpur
Smartcare Dialysis Centre
Kuala Lumpur, Kuala Lumpur
The Kidney Dialysis Centre
Kuala Lumpur, Kuala Lumpur
Pahang Buddhist Association
Kuantan, Pahang
Pusat Hemodialisis Islam Makmur
Kuantan, Pahang
SP Menon Dialysis Centre
Petaling Jaya, Selangor
Tan Medical Renal Clinic
Petaling Jaya, Selangor
Klinik Pakar Dialysis
Subang Jaya, Selangor
Sunway Medical Centre
Subang Jaya, Selangor
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Disease, End-Stage Renal Failure, Anaemia
- Being tested
- Biogeneric Epoetin
- Keywords
- Biogeneric Epoetin treatment, Renal anaemia, Chronic Kidney Disease, Pure Red Blood Cell Aplasia, Hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biogeneric EpoetinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startAug 2005
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Investigators
- Dato' Dr. Zaki Morad Mohamad Zaher, MRCP, FRCP, Principal investigator, Department of Nephrology, Kuala Lumpur Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238043
- Sponsor's protocol ID
- CT 05-17
- Status last verified
- Oct 2005
- First submitted
- 12 Oct 2005
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study to Determine the Long-Term Safety and Efficacy of Biogeneric Epoetin Treatment for Renal Anemia
- ClinicalTrials.gov ID
- NCT00238043
- Acronym / sponsor ID
- CT 05-17
- Conditions
- Chronic Kidney Disease, End-Stage Renal Failure, Anaemia
- Keywords
- Biogeneric Epoetin treatment, Renal anaemia, Chronic Kidney Disease, Pure Red Blood Cell Aplasia, Hemodialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Study start
- Aug 2005
- Study completion
- Apr 2011 (estimated)
- First posted
- 13 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biogeneric Epoetin | Drug | – |
Primary outcome
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.
1 secondary outcome
Mortality, quality of life and cost during the 6 years study treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2008.
- the link is an academic research organisation for the trialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dato' Dr. Zaki Morad Mohamad Zaher, MRCP, FRCP principal investigator
Department of Nephrology, Kuala Lumpur Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biogeneric Epoetin in people with Chronic Kidney Disease and End-Stage Renal Failure, run by Ministry of Health, Malaysia at 14 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2008.