Pharmacokinetic interactions between probenecid and the combination mycophenolate mofetil - cyclosporine/tacrolimus in stable renal allograft recipients
- Conditions
- Renal transplant recipients treated with mycophenolate mofetil and tacrolimus.
- Registration Number
- EUCTR2005-000012-27-BE
- Lead Sponsor
- Department of Nephrology and Renal Transplantation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
stable renal transplant recipients treated with mycophenolate mofetil and tacrolimus
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- use of other immunosuppressive drug therapy
- use of durgs known to interact with rifampicin
- combined organ transplants
- documented non-compliance
- acute rejection in the last 3 months
- severely impaired renal function
- hypoalbuminemia
- liver disease
- chronic diarrhea
- pregnancy
- fertile female patients of childbearing age
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate an interaction between mycophenolate mofetil and probenecid in renal allograft recipients;Secondary Objective: /;Primary end point(s): The observation of a significant influence of probenecid on mycophenolate mofetil pharmacokinetics
- Secondary Outcome Measures
Name Time Method