Health Condition 1: N186- End stage renal disease
Conditions
Interventions
Intervention1: tacrolimus: 0.1mg/kg single dose (only once), 4-7 days prior to renal transplantation surgery
Control Intervention1: Not applicable: Not applicable
Sponsors
Dr Ashish Sharma
Eligibility
Inclusion criteria
Inclusion criteria: Patients with ESRD who are planned to undergo renal transplantation
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 obtained after transplantation day 2, 5, 8, 15 and 30. Timepoint: Pre-Transplant: 0, 0.5, 2, 5,8,12 hours after the dose Post-transplant: day 2,5,8,15,30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Post-transplant: day 2,5,8,15,30;To build a pharmacokinetic model for finding the starting dose of tacrolimus required for attaining therapeutic concentration based on the pharmacokinetic data of tacrolimus and other demographic characteristics of the patientsTimepoint: Pre-Transplant: 0, 0.5, 2, 5,8,12 hours after the dose Post-transplant: day 2,5,8,15,30 | — |
Countries
India
Contacts
Public ContactDr Ashish Sharma
Post Graduate Institute Of Medical Education and Research
Outcome results
None listed