De Novo Kidney TransplantPhase 3NCT00284921
MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive
A Phase 3 study testing Enteric-coated Mycophenolate sodium (EC-MPS) in people with De Novo Kidney Transplant, run by Novartis Pharmaceuticals.
Trial summary
To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- De Novo Kidney Transplant
- What is being tested?
- Enteric-coated Mycophenolate sodium (EC-MPS)
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Aug 2006
- 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 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patients hepatitis C positive (serology test within the last 12 months and determined by third-generation assay).
- Recipients of heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with basiliximab and CsA-ME as primary immunosuppression.
Who cannot join
- Multi-organ recipients (e.g. double kidney, kidney and pancreas or kidney and liver) or previous transplant with any other organ.
- Kidneys from non-heart beating donors.
- ABO incompatibility against the donor.
- Patients with panel reactive antibodies of >50% at most recent assessment prior to transplantation and /or prior graft lost due to immunological reasons in the first six months post-transplantation or patients who are considered to be at increased risk of acute rejection by the principal investigator Additional protocol defined inclusion/exclusion criteria may apply.
About this study
Official title: A Twelve-month, Randomized, Multicenter, Open-label, Exploratory Study to Investigate the Clinical Outcomes of an Immunosuppressive Regimen of Basiliximab, Cyclosporine Microemulsion (CsA-ME) and Enteric-coated Mycophenolate Sodium (EC-MPS) Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients Who Are Hepatitis C Positive
To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment.
- Conditions
- De Novo Kidney Transplant
- Being tested
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Keywords
- kidney transplant, hepatitis C, enteric-coated mycophenolate sodium
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteric-coated Mycophenolate sodium (EC-MPS)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic function tests (ALT/AST) after 12 months treatment.
Secondary outcomes (9)
Acumulative incidence of biopsy proven acute rejection after 3 and 12 months.
Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment.
Glomerular filtration rate and by proteinuria after 12 months treatment.
Graft survival after 12 months.
Incidence of AEs and SAEs after 3 and 12 months.
Blood pressure, lipids and glucose profiles after 3 and 12 months.
Percentage of patients free of steroids at 12 months between the two investigational groups.
Viral load (HCV RNA) between both groups at 12 months.
Bone density at 12 months in both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startApr 2004
- Primary completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for De Novo Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284921
- Sponsor's protocol ID
- CERL080AES02
- Status last verified
- Nov 2011
- First submitted
- 30 Jan 2006
- Last updated
- 2 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve-month, Randomized, Multicenter, Open-label, Exploratory Study to Investigate the Clinical Outcomes of an Immunosuppressive Regimen of Basiliximab, Cyclosporine Microemulsion (CsA-ME) and Enteric-coated Mycophenolate Sodium (EC-MPS) Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients Who Are Hepatitis C Positive
- ClinicalTrials.gov ID
- NCT00284921
- Acronym / sponsor ID
- CERL080AES02
- Conditions
- De Novo Kidney Transplant
- Keywords
- kidney transplant, hepatitis C, enteric-coated mycophenolate sodium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Aug 2006 (actual)
- First posted
- 1 Feb 2006 (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.
To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients hepatitis C positive (serology test within the last 12 months and determined by third-generation assay).
- Recipients of heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with basiliximab and CsA-ME as primary immunosuppression.
Key exclusion criteria (4 listed)
- Multi-organ recipients (e.g. double kidney, kidney and pancreas or kidney and liver) or previous transplant with any other organ.
- Kidneys from non-heart beating donors.
- ABO incompatibility against the donor.
- Patients with panel reactive antibodies of >50% at most recent assessment prior to transplantation and /or prior graft lost due to immunological reasons in the first six months post-transplantation or patients who are considered to be at increased risk of acute rejection by the principal investigator Additional protocol defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| Enteric-coated Mycophenolate sodium (EC-MPS) | Drug | – |
Primary outcome
Hepatic function tests (ALT/AST) after 12 months treatment.
9 secondary outcomes
Acumulative incidence of biopsy proven acute rejection after 3 and 12 months.
Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment.
Glomerular filtration rate and by proteinuria after 12 months treatment.
Graft survival after 12 months.
Incidence of AEs and SAEs after 3 and 12 months.
Blood pressure, lipids and glucose profiles after 3 and 12 months.
Percentage of patients free of steroids at 12 months between the two investigational groups.
Viral load (HCV RNA) between both groups at 12 months.
Bone density at 12 months in both groups.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
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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.
Novartis study director
Novartis
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enteric-coated Mycophenolate sodium (EC-MPS) in people with De Novo Kidney Transplant, run by Novartis Pharmaceuticals.
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 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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. 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?
Hepatic function tests (ALT/AST) after 12 months treatment.. 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 2 Nov 2011.