A Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)

Renal Transplantation Clinical Trial

Official title:

A 6-month, 1-arm, Open-label Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238979
• Other study ID #: CERL080ADE03
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2005
• Last updated: November 1, 2011
• Start date: January 2003

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: February 2005
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• Recipients of first or secondary cadaveric heart-beating, living unrelated or living related kidney transplant.

• Currently receiving 1, 1.5, or 2 g MMF/day, tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months.

• In a stable condition in terms of graft function.

Exclusion criteria:

• Patients who had taken an investigational drug within four weeks prior to study entry

• History of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.

• 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

• Clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, evidence of severe liver disease, HIV or Hepatitis B surface antigen positive.

Other protocol-defined inclusion/exclusion criteria may apply.

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

• Renal Transplantation

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	Tolerability based on adverse events within 6 months after switch from MMF to an optimized enteric-coated mycophenolate sodium regimen.
Secondary	Safety based on renal function within 6 months after medication switch.
Secondary	Pharmacokinetics of enteric-coated mycophenolate sodium in combination with tacrolimus in a subpopulation at baseline, week 2, month 3
Secondary	Influence of enteric-coated mycophenolate sodium on the activity of an enzyme at baseline, week 2, month 3
Secondary	Incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.
Secondary	Graft survival and patient survival 6 months post medication switch.