An open study to investigate the effect of 4 instead of 2 daily dosing mycophenolate mofetil (MMF) in renal transplant patients on diarrhea - 4xMMF

• Conditions: Diarrhea in renal transplanted patients which use Cellcept®; MedDRA version: 9.1Level: LLTClassification code 10021176Term: Iatrogenic diarrhea; MedDRA version: 9.1Level: LLTClassification code 10023438Term: Kidney transplant; MedDRA version: 9.1Level: LLTClassification code 10054980Term: Immunosuppressant drug therapy

• Registration Number: EUCTR2007-000033-19-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Male or female > 18 years old
Renal transplantation > 6 months with stable renal function (serum creatinine < 250 mumol/L)
Use of MMF (Cellcept®) 2 times daily
History of diarrhea (> 1 month = 3 times a day loose/ watery stool in at least 75% of the cases)
Willing and capable to give written informed consent
Able to communicate and cooperate with the investigators

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

Usage of morfinomimetics, anti-diarretics, laxans or other drugs that are known to induce diarrhea.
Recent use of antibiotics (< 4 weeks before study)
Gastro-intestinal infections (Yersinea, Campylobacter, Shigella, Salmonella, Clostridium difficile toxin, CMV)
Known gastro-intestinal diseases or recent major gastro-intestinal surgery

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure.;Secondary Objective: Increasing the quality of life and effect on intestinal permeability.;Primary end point(s): - Stool frequency and faeces weight<br>- Incidence of acute graft rejection (according to BANFF 1997 criteria)