Effect of mild diarrhea on tacrolimus exposure

Effect of mild diarrhea on tacrolimus exposure - Diarrhea and tacrolimus exposure

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32863

Enrollment

Registered

2009-09-08

Start date

2010-05-25

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal transplantation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Difference in the ratio AUC:trough level of tacrolimus between subjects with mild diarrhea and controls.	—

Secondary

Measure	Time frame
Correlation between two measurements of ratio AUC:trough level of tacrolimus in the same subject.	—

Countries

Netherlands

Outcome results