Health Condition 1: N186- End stage renal disease
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
InvestigatorInitiated Study
Eligibility
Inclusion criteria
Inclusion criteria: 1. Renal transplant recipients aged 18-50 years 2. Treated with Tacrolimus as a part of the standard triple immunosuppression regimen 3. Willing to comply with the study procedures, study visit schedule and other protocol requirements
Exclusion criteria
Exclusion criteria: 1. Known case of diabetes mellitus 2. Re-transplantation, combined transplantation eg Simultaneous Pancreas Kidney 3. Patients harbouring HIV, hepatitis B, or C infection 4. Suffering from any malignancy 5. Patients suffering from any acute systemic infection within 30 days before enrolment 6. Patients who had received any investigational drug within the past 6 months 7. Pregnant or nursing mothers 8. Use of medications CYP inducers or inhibitors or others known to affect the tacrolimus blood concentration. 9. Participation in other interventional clinical trials (inclusive of the Follow-up period) 10. Patients with known non-adherence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The proportion of participants with deranged OGTT before and after 45 days of transplantation on immediate-release tacrolimus for CYP3A5 expressers and non-expressersTimepoint: 45 days | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be compared between the CYP3A5 expressors / non-expressors genotypes: 1.The proportion of participants with PTDM on immediate-release tacrolimus for CYP3A5 expressers and non-expressers within 12 months 2. Exposure to tacrolimus in one dosing interval (AUC 0-12) at one-month post-transplantation 3. Change in biomarkers (Fasting insulin, OGTT insulin, C-peptide in the pre-transplant period and post-transplant period (45 days). 4. Time to reach the therapeutic window, length of hospital stay, acute rejection rates, lipid profile (Triglyceride) and graft outcome (eGFR & urinary albumin)Timepoint: 3-12 months | — |
Countries
India
Contacts
Public ContactSmita Pattanaik
PostGraduate Institute of Medical Education & Research, Chandigarh
Outcome results
None listed