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
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: October 12, 2005
Last updated: November 1, 2011
Last verified: November 2011
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.
Kidney Transplant Recipients
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||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
Primary Outcome Measures:
- Adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen .
Secondary Outcome Measures:
- Pharmacokinetic profiles of MMF and EC-MPS.
- Patient and graft survival, graft function
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||July 2005 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
- 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.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00239044
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 12, 2005
||November 1, 2011
||Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Keywords provided by Novartis:
Kidney transplant recipients; Enteric-coated Mycophenolate sodium (EC-MPS)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 19, 2014
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs