An open study to investigate the effect of 4 instead of 2 daily dosing mycophenolate mofetil (MMF) in renal transplant patients on diarrhea
Phase 4
Completed
- Conditions
- transplantatie geneeskundeRenal transplantation
- Registration Number
- NL-OMON30619
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Stool frequency and faeces weight<br /><br>- Incidence of acute graft rejection (according to BANFF 1997 criteria)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Quality of life as measured by the SF36 questionnaire<br /><br>- Renal function as measured by serum creatinine and creatinine clearance<br /><br>(Cockcroft-Gault formula)<br /><br>- Intestinal permeability as measured by the intestinal permeability<br /><br>lactulose-mannitol test<br /><br>- Comparison of the 2 hours MMF-AUC (0, 30, 60, 90 and 120 min) between a 2 and<br /><br>4 times daily schedule<br /><br>- Faeces bacterial profile<br /><br>- Incidence of adverse events<br /><br>- Co-medication used during the study will be analyzed </p><br>