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

NCT00239044 | Completed Phase 3

• 1 other identifier: CERL080A2405NL01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Kidney Transplant Recipients

Keywords

Kidney transplant recipients; Enteric-coated Mycophenolate sodium (EC-MPS)

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Enteric-coated Mycophenolate sodium (EC-MPS) DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 14, 2005
• Study Start: December 1, 2002
• Primary Completion: July 1, 2005
• Last Updated: November 2, 2011

Record last verified: 2011-11