Effect of mild diarrhea on tacrolimus exposure
Phase 4
Recruiting
- Conditions
- renal transplantation10038430
- Registration Number
- NL-OMON32863
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1. Recipient of a renal graft
2. Age: 18 years or older
3. Informed consent
4. At least 2 months after renal transplantation
5. Treatment with the combination of tacrolimus and MMF
6. Tacrolimus trough levels within the target range (5-10 ng/ml) at two subsequent occasions.
Cases: Average stool frequency 2-3 times/day OR unbound stools during last two weeks prior to inclusion.
Controls: Average stool frequency 1 time/day or less AND normal consistency of stools during last two weeks prior to inclusion.
Exclusion Criteria
1. History of bowel resection
2. Severe diarrhea (> 3 stools per day)
3. Rectal blood loss
4. Signs of active CMV infection
5. Change in tacrolimus dosage within one week prior to inclusion
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Difference in the ratio AUC:trough level of tacrolimus between subjects with<br /><br>mild diarrhea and controls. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Correlation between two measurements of ratio AUC:trough level of tacrolimus in<br /><br>the same subject.</p><br>