Maintenance Renal TransplantationPhase 3NCT00239057
Study of Enteric-coated Mycophenolate Sodium Maintenance Therapy in Patients With Renal Transplant Receiving Cyclosporine Microemulsion and Steroids,
A Phase 3 study testing Enteric-Coated Mycophenolate Sodium in people with Maintenance Renal Transplantation, run by Novartis.
Trial summary
The aim of this study is to evaluate if the addition of EC-MPS to CsA-ME allows the safe withdrawal of the concomitant corticosteroid therapy in long-term maintenance renal allograft recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maintenance Renal Transplantation
- What is being tested?
- Enteric-Coated Mycophenolate Sodium
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Jan 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 1. Male or female, 18 years of age or older. 2. Recipients of first or secondary cadaver, living related or unrelated donor kidney transplant performed at least 6 month before screening (Visit 1) 3. Patients currently receiving CsA-ME and corticosteroids (at least 5 mg of prednisone equivalents) for at least 3 months prior to Screening, with or without Mycophenolate mofetil or azathioprine.
- 4. Serum creatinine levels < 2.3 mg/dL (=204 µmol/L) at screening and at baseline 5. Stable kidney function, i.e. increase in serum creatinine less than 20% in the last 3 months before screening and at baseline (baseline value as compared to the value obtained at screening) Exclusion Criteria
- Multi-organ recipients (e.g., kidney and pancreas, double kidneys) or previous transplant with any other organ different from kidney
- Patients whit a second transplant who rejected the first one for immunological reasons or because of the relapse of the autoimmune disease which leaded to the end-stage renal failure
- Histological evidence of acute rejection or treatment for acute rejection within the three months prior to Screening, or histological signs or clinical signs of chronic rejection (as significant proteinuria, i.e. > 300 mg/24 hours.
- Patients with maintenance steroid therapy for other diseases (i.e. autoimmune diseases, Lupus).
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- 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 (<4,000/mm3), and/or anemia (hemoglobin <9.0 g/dL) prior to Screening visit.
- Patients who have received an investigational drug within two weeks prior to Screening visit.
- Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
- 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.
- Any changes of immunosuppressive regimen due to graft malfunction, or any known clinically significant physical and/or laboratory changes in the 2 months prior to Screening visit.
- Known positivity for HIV, HBsAg
- Active viral hepatitis, as shown by liver function tests (AST or ALT) higher than twice the upper limit of normality
- Evidence of drug and/or alcohol abuse Other inclusion/exclusion criteria may apply
Who cannot join
None listed.
About this study
Official title: Enteric-Coated Mycophenolate Sodium (EC-MPS) Administration in Maintenance Renal Transplant Patients Receiving Cyclosporine Microemulsion (CsA-ME) and Steroids, for the Withdrawal of Concomitant Steroid Therapy: a Prospective, Open-label, Exploratory Study
The aim of this study is to evaluate if the addition of EC-MPS to CsA-ME allows the safe withdrawal of the concomitant corticosteroid therapy in long-term maintenance renal allograft recipients.
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.
- Conditions
- Maintenance Renal Transplantation
- Being tested
- Enteric-Coated Mycophenolate Sodium
- Keywords
- Renal transplantation, EC-MPS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteric-Coated Mycophenolate SodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of biopsy prove acute rejection requiring treatment within six months of the start of the study.
Secondary outcomes (3)
Assessment of the changes in body-weight, blood pressure, serum lipid levels, renal function, glaciated hemoglobin, dermatological condition and quality of life six months after the start of the study
Safety and tolerability
Pharmacokinetics of MPA and MPAG in the patient subgroup that was receiving MMF (screening period) before the start of the study and two weeks after the start of the administration of EC-MPS.
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 startMay 2002
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maintenance Renal TransplantationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239057
- Sponsor's protocol ID
- CERL080A2405IT03
- Status last verified
- Jan 2011
- First submitted
- 12 Oct 2005
- Last updated
- 31 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteric-Coated Mycophenolate Sodium (EC-MPS) Administration in Maintenance Renal Transplant Patients Receiving Cyclosporine Microemulsion (CsA-ME) and Steroids, for the Withdrawal of Concomitant Steroid Therapy: a Prospective, Open-label, Exploratory Study
- ClinicalTrials.gov ID
- NCT00239057
- Acronym / sponsor ID
- CERL080A2405IT03
- Conditions
- Maintenance Renal Transplantation
- Keywords
- Renal transplantation, EC-MPS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 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.
The aim of this study is to evaluate if the addition of EC-MPS to CsA-ME allows the safe withdrawal of the concomitant corticosteroid therapy in long-term maintenance renal allograft recipients.
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1. Male or female, 18 years of age or older. 2. Recipients of first or secondary cadaver, living related or unrelated donor kidney transplant performed at least 6 month before screening (Visit 1) 3. Patients currently receiving CsA-ME and corticosteroids (at least 5 mg of prednisone equivalents) for at least 3 months prior to Screening, with or without Mycophenolate mofetil or azathioprine.
- 4. Serum creatinine levels < 2.3 mg/dL (=204 µmol/L) at screening and at baseline 5. Stable kidney function, i.e. increase in serum creatinine less than 20% in the last 3 months before screening and at baseline (baseline value as compared to the value obtained at screening) Exclusion Criteria
- Multi-organ recipients (e.g., kidney and pancreas, double kidneys) or previous transplant with any other organ different from kidney
- Patients whit a second transplant who rejected the first one for immunological reasons or because of the relapse of the autoimmune disease which leaded to the end-stage renal failure
- Histological evidence of acute rejection or treatment for acute rejection within the three months prior to Screening, or histological signs or clinical signs of chronic rejection (as significant proteinuria, i.e. > 300 mg/24 hours.
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 |
|---|---|---|
| Enteric-Coated Mycophenolate Sodium | Drug | – |
Primary outcome
Incidence of biopsy prove acute rejection requiring treatment within six months of the start of the study.
3 secondary outcomes
Assessment of the changes in body-weight, blood pressure, serum lipid levels, renal function, glaciated hemoglobin, dermatological condition and quality of life six months after the start of the study
Safety and tolerability
Pharmacokinetics of MPA and MPAG in the patient subgroup that was receiving MMF (screening period) before the start of the study and two weeks after the start of the administration of EC-MPS.
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 31 Jan 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 in people with Maintenance Renal Transplantation, run by Novartis.
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 16 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: finished, as of the sponsor's last update on 31 Jan 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?
Incidence of biopsy prove acute rejection requiring treatment within six months of the start of the study.. 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 31 Jan 2011.