Kidney Transplant RecipientsPhase 3NCT00239044
An Open Label Study to Evaluate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Maintenance Renal Transplant Recipients
A Phase 3 study testing Enteric-coated Mycophenolate sodium (EC-MPS) in people with Kidney Transplant Recipients, run by Novartis Pharmaceuticals.
Trial summary
To evaluate whether maintenance renal transplant patients on micophenolate mofetil (MMF) can be safely converted to EC-MPS, based on adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Transplant Recipients
- What is being tested?
- Enteric-coated Mycophenolate sodium (EC-MPS)
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Jul 2005
- 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 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Males and females aged between 18 and 80 years.
- Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant at least 6 months after transplantation.
- Patients currently receiving CsA-ME with MMF , with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months prior to Screening.
- Patients receiving MMF at reduced dose prior to study entry
- Patients in a stable condition in terms of graft function (serum creatinine not above 2.3 mg/dL (=204 µmol/L) at screening and at baseline, or not increased by more than 20% at baseline compared to values obtained at screening), no change of immunosuppressive regimen due to graft malfunction, and any known clinically significant physical and/or laboratory changes for at least 2 months prior to enrollment.
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to or at screening. Effective contraception must be used during the trial, and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
- Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
Who cannot join
- Multi-organ patients (e.g., kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed)
- Evidence of graft rejection or treatment of acute rejection within two months prior to Screening.
- Patients with any known hypersensitivity to EC-MPS or other components of the formulation (e.g., lactose)
- Patients with thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<2,500/mm3), and/or hemoglobin <6.0 g/dL prior to enrollment.
- Patients who have received an investigational drug within two weeks prior to Screening (i.e., before Day -14 of run-in period).
- Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
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- Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
- Presence of clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that would interfere with the appropriate conduct of the study.
- Known positive HIV and/or Hepatitis B surface antigen positive.
- Evidence of drug and/or alcohol abuse.
About this study
To evaluate whether maintenance renal transplant patients on micophenolate mofetil (MMF) can be safely converted to EC-MPS, based on adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen.
- Conditions
- Kidney Transplant Recipients
- Being tested
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Keywords
- Kidney transplant recipients; Enteric-coated Mycophenolate sodium (EC-MPS)
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.
Adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen .
Secondary outcomes (3)
Pharmacokinetic profiles of MMF and EC-MPS.
Patient and graft survival, graft function
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startDec 2002
- Primary completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RecipientsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT00239044
- Sponsor's protocol ID
- CERL080A2405NL01
- Status last verified
- Nov 2011
- First submitted
- 12 Oct 2005
- 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
- An Open Label Study to Evaluate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Maintenance Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00239044
- Acronym / sponsor ID
- CERL080A2405NL01
- Conditions
- Kidney Transplant Recipients
- Keywords
- Kidney transplant recipients; Enteric-coated Mycophenolate sodium (EC-MPS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jul 2005 (actual)
- First posted
- 14 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.
To evaluate whether maintenance renal transplant patients on micophenolate mofetil (MMF) can be safely converted to EC-MPS, based on adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females aged between 18 and 80 years.
- Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant at least 6 months after transplantation.
- Patients currently receiving CsA-ME with MMF , with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months prior to Screening.
- Patients receiving MMF at reduced dose prior to study entry
- Patients in a stable condition in terms of graft function (serum creatinine not above 2.3 mg/dL (=204 µmol/L) at screening and at baseline, or not increased by more than 20% at baseline compared to values obtained at screening), no change of immunosuppressive regimen due to graft malfunction, and any known clinically significant physical and/or laboratory changes for at least 2 months prior to enrollment.
Key exclusion criteria (10 listed)
- Multi-organ patients (e.g., kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed)
- Evidence of graft rejection or treatment of acute rejection within two months prior to Screening.
- Patients with any known hypersensitivity to EC-MPS or other components of the formulation (e.g., lactose)
- Patients with thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<2,500/mm3), and/or hemoglobin <6.0 g/dL prior to enrollment.
- Patients who have received an investigational drug within two weeks prior to Screening (i.e., before Day -14 of run-in period).
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
Adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen .
3 secondary outcomes
Pharmacokinetic profiles of MMF and EC-MPS.
Patient and graft survival, graft function
Safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Kidney Transplant Recipients, 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 7 inclusion and 10 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen .. 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.