Tacrolimus disposition in the patients before renal transplantatio
Not Applicable
- Conditions
- Health Condition 1: N186- End stage renal disease
- Registration Number
- CTRI/2018/10/016099
- Lead Sponsor
- Dr Ashish Sharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with ESRD who are planned to undergo renal transplantation
Exclusion Criteria
1. Patients undergoing multi- organ transplantation
2. Patients harboring HIV, Hepatitis B or C infections
3.Patients suffering from any acute systemic infections within 30 days prior to enrollment
4.Patients who had received any investigational drug within past 6
months
5. Pregnant, nursing mothers or women of childbearing potential without an effective method of birth control
6. Use of medications known to affect tacrolimus pharmacokinetics
7. Not willing to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between pre-transplant whole blood concentration of tacrolimus (single dose) at 2,5,8 or 12 hours (C2, C5, C8, C12) with the first trough(C0) of tacrolimus <br/ ><br>obtained after transplantation day 2, 5, 8, 15 and 30. <br/ ><br>Timepoint: Pre-Transplant: 0, 0.5, 2, 5,8,12 hours after the dose <br/ ><br>Post-transplant: day 2,5,8,15,30
- Secondary Outcome Measures
Name Time Method Correlation of the pharmacogenomic determinants of tacrolimus to pre-transplant AUC and post-transplant dose requirementTimepoint: Pre-Transplant: 0, 0.5, 2, 5,8,12 hours after the dose <br/ ><br>Post-transplant: day 2,5,8,15,30;To build a pharmacokinetic model for finding the <br/ ><br>starting dose of tacrolimus required for attaining <br/ ><br>therapeutic concentration based on the <br/ ><br>pharmacokinetic data of tacrolimus and other <br/ ><br>demographic characteristics of the patientsTimepoint: Pre-Transplant: 0, 0.5, 2, 5,8,12 hours after the dose <br/ ><br>Post-transplant: day 2,5,8,15,30