A clinical trial to adjust the dose of Tacrolimus in renal transplant patients with fast liver metabolism
Not Applicable
- Conditions
- Health Condition 1: N186- End stage renal diseaseHealth Condition 2: N186- End stage renal diseaseHealth Condition 3: N186- End stage renal diseaseHealth Condition 4: N186- End stage renal diseaseHealth Condition 5: N186- End stage renal disease
- Registration Number
- CTRI/2023/02/049758
- Lead Sponsor
- IQRAA INTERNATIONAL HOSPITAL AND RESEARCH CENTER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
First objective- All pre and post-renal transplant patients willing to participate in the study.
Second objective- patients found to be extensive metabolizer for tacrolimus on genotyping.
Exclusion Criteria
Patients not willing/cooperative for the study. Patients who are on other drugs which interfere with the tacrolimus level. Patients with abnormal LFT and patients who are not available for follow up.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of pharmacokinetic, and pharmacodynamic actions of the drug among extensive metabolizers <br/ ><br>Timepoint: Between two patient visits with an interval of one month.
- Secondary Outcome Measures
Name Time Method Tacrolimus maximum blood levelsTimepoint: will be measured 1.5 hours after the dose administration.