Anti-r-HuEpo Associated PRCA SubjectsPhase 3NCT01288131
Study of Anti-r-HuEpo Associated Pure Red Cell Aplasia (PRCA) Treatment
A Phase 3 study testing Cyclosporine combine with mycophenolate mofetil and Cyclophosphamide + pred in people with Anti-r-HuEpo Associated PRCA Subjects, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Recombinant human erythropoietin (r-HuEpo) has been used to treat renal anemia and improve morbidity and mortality in chronic kidney disease. Subcutaneous use of r-HuEpo causes immunogenicity and develops anti-r-HuEpo associated pure red cell aplasia (PRCA). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anti-r-HuEpo Associated PRCA Subjects
- What is being tested?
- Cyclosporine combine with mycophenolate mofetil and Cyclophosphamide + pred
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2009to Jan 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age more than 18 years old
- CKD patient with anti-r-huEpo associated PRCA
Who cannot join
- Pregnancy or lactating women
- Receiving immunosuppression
- Active infection
- Previous history of allergic reaction to cyclosporine, mycophenolate mofetil, cyclophosphamide, prednisolone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Study of Anti-r-HuEpo Associated PRCA Treated by Cyclosporine and Mycophenolate Mofetil (MMF) Compared With Cyclophosphamide and Prednisolone
Recombinant human erythropoietin (r-HuEpo) has been used to treat renal anemia and improve morbidity and mortality in chronic kidney disease. Subcutaneous use of r-HuEpo causes immunogenicity and develops anti-r-HuEpo associated pure red cell aplasia (PRCA). The treatment of anti-r-HuEpo associated pure red cell aplasia is controversial. The investigators aim to evaluate the treatment for anti-r-HuEpo associated pure red cell aplasia in this study.
Read the detailed description
Recombinant human erythropoietin was the first biotherapeutic medicinal product derived from recombinant DNA technology for the treatment of anemia in patients with chronic kidney disease (CKD). Although r-HuEpo raises hemoglobin levels in CKD and improves morbidity associated with anemia in CKD patients, the adverse immunological effect of r-HuEpo administered subcutaneously can result in anti-r-HuEpo associated PRCA. We aim to evaluate the effectiveness of two treatment protocol, cyclosporine combined with mycophenolate mofetil and cyclophosphamide combined with prednisolone for treatment of anti-r-HuEpo associated PRCA.
- Conditions
- Anti-r-HuEpo Associated PRCA Subjects
- Being tested
- Cyclosporine combine with mycophenolate mofetil, Cyclophosphamide + pred
- Keywords
- Anti-r-HuEpo antibody, Anti-r-HuEpo associated PRCA, Treatment, Absolute reticulocyte count
- Medical subject headings
- AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine combine with mycophenolate mofetilDrug
Also called Neoral, Cellcept
Cyclosporine 100 mg BID and mycophenolate mofetil 750 mg BID for 24 weeks
Cyclophosphamide + predDrug
Also called Endoxan
Cyclophosphamide 100 mg QD combine with prednisolon 1.0 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| CSA+MMF | Active comparator | Cyclosporine 100 mg BID combine with Mycophenolate mofetil 750 mg BID for 24 weeks Receives: Drug: Cyclosporine combine with mycophenolate mofetil |
| Cyclophosphamide + pred | Active comparator | Cyclophosphamide 100 mg QD and prednisolone 1.0 mg/kg/day Receives: Drug: Cyclophosphamide + pred |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-r-HuEpo antibody
The anti-r-HuEpo antibody titer at day 0 (before treatment) and month 6 (6th month after treatment) of each arm will be compared
Measured: Day 0 and month 6
Secondary outcomes (1)
Absolute reticulocyte count
The Absolute reticulocyte count at day 0 (before treatment) and month 6 (6th month after treatment) of each arm will be compared
Measured: Day 0 and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJan 2009
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: We observed \>90 % efficacy in cyclophosphamide and Prednisolone group for treatment of anti-i-HuEpo associated PRCA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-r-HuEpo Associated PRCA SubjectsStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kearkiat Praditpornsilpa, Chulalongkorn University
- Investigators
- Kearkiat Praditpornsilpa, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288131
- Sponsor's protocol ID
- 2011/01_Medicine
- Status last verified
- Jan 2014
- First submitted
- 1 Feb 2011
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Study of Anti-r-HuEpo Associated PRCA Treated by Cyclosporine and Mycophenolate Mofetil (MMF) Compared With Cyclophosphamide and Prednisolone
- ClinicalTrials.gov ID
- NCT01288131
- Acronym / sponsor ID
- 2011/01_Medicine
- Conditions
- Anti-r-HuEpo Associated PRCA Subjects
- Keywords
- Anti-r-HuEpo antibody, Anti-r-HuEpo associated PRCA, Treatment, Absolute reticulocyte count
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We observed \>90 % efficacy in cyclophosphamide and Prednisolone group for treatment of anti-i-HuEpo associated PRCA
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Feb 2011 (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.
Recombinant human erythropoietin (r-HuEpo) has been used to treat renal anemia and improve morbidity and mortality in chronic kidney disease. Subcutaneous use of r-HuEpo causes immunogenicity and develops anti-r-HuEpo associated pure red cell aplasia (PRCA). The treatment of anti-r-HuEpo associated pure red cell aplasia is controversial. The investigators aim to evaluate the treatment for anti-r-HuEpo associated pure red cell aplasia in this study.
Detailed description
Recombinant human erythropoietin was the first biotherapeutic medicinal product derived from recombinant DNA technology for the treatment of anemia in patients with chronic kidney disease (CKD). Although r-HuEpo raises hemoglobin levels in CKD and improves morbidity associated with anemia in CKD patients, the adverse immunological effect of r-HuEpo administered subcutaneously can result in anti-r-HuEpo associated PRCA. We aim to evaluate the effectiveness of two treatment protocol, cyclosporine combined with mycophenolate mofetil and cyclophosphamide combined with prednisolone for treatment of anti-r-HuEpo associated PRCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSA+MMF | Active comparator | Drug: Cyclosporine combine with mycophenolate mofetilCyclosporine 100 mg BID combine with Mycophenolate mofetil 750 mg BID for 24 weeks |
| Cyclophosphamide + pred | Active comparator | Drug: Cyclophosphamide + predCyclophosphamide 100 mg QD and prednisolone 1.0 mg/kg/day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age more than 18 years old
- CKD patient with anti-r-huEpo associated PRCA
Key exclusion criteria (4 listed)
- Pregnancy or lactating women
- Receiving immunosuppression
- Active infection
- Previous history of allergic reaction to cyclosporine, mycophenolate mofetil, cyclophosphamide, prednisolone
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 |
|---|---|---|
| Cyclosporine combine with mycophenolate mofetilAlso: Neoral, CellceptCyclosporine 100 mg BID and mycophenolate mofetil 750 mg BID for 24 weeks | Drug | CSA+MMF |
| Cyclophosphamide + predAlso: EndoxanCyclophosphamide 100 mg QD combine with prednisolon 1.0 mg/kg/day | Drug | Cyclophosphamide + pred |
Primary outcome
anti-r-HuEpo antibody
Time frame: Day 0 and month 6
The anti-r-HuEpo antibody titer at day 0 (before treatment) and month 6 (6th month after treatment) of each arm will be compared
1 secondary outcome
Absolute reticulocyte count
Time frame: Day 0 and month 6
Results and safety
The study was stopped early (reason given: We observed \>90 % efficacy in cyclophosphamide and Prednisolone group for treatment of anti-i-HuEpo associated PRCA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
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.
Kearkiat Praditpornsilpa, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclosporine combine with mycophenolate mofetil and Cyclophosphamide + pred in people with Anti-r-HuEpo Associated PRCA Subjects, run by Chulalongkorn University at 1 site in Thailand.
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 4 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: stopped early, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
The study was stopped early (reason given: We observed \>90 % efficacy in cyclophosphamide and Prednisolone group for treatment of anti-i-HuEpo associated PRCA). 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?
anti-r-HuEpo antibody (time frame: Day 0 and month 6). 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 29 Jan 2014.