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

Kidney Transplant Recipients Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239044
• Other study ID #: CERL080A2405NL01
• Status: Completed
• Phase: Phase 3
• First received: October 12, 2005
• Last updated: November 1, 2011
• Start date: December 2002

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: July 2005
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria

1. Males and females aged between 18 and 80 years.

2. Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant at least 6 months after transplantation.

3. 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.

4. Patients receiving MMF at reduced dose prior to study entry

5. 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.

6. 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.

7. Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion Criteria

1. Multi-organ patients (e.g., kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed)

2. Evidence of graft rejection or treatment of acute rejection within two months prior to Screening.

3. Patients with any known hypersensitivity to EC-MPS or other components of the formulation (e.g., lactose)

4. 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.

5. Patients who have received an investigational drug within two weeks prior to Screening (i.e., before Day -14 of run-in period).

6. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.

7. 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

8. 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.

9. Known positive HIV and/or Hepatitis B surface antigen positive.

10. Evidence of drug and/or alcohol abuse.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplant Recipients

Intervention

Drug:
• Enteric-coated Mycophenolate sodium (EC-MPS)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen .
Secondary	Pharmacokinetic profiles of MMF and EC-MPS.
Secondary	Patient and graft survival, graft function
Secondary	Safety