Health Condition 1: N185- Chronic kidney disease, stage 5
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Genotype guided Tacrolimus dosing: The intervention group will receive Tacrolimus in the following doses based on their CYP3A5 genotype.
CYP3A5*1/*1 : 0.25mg/kg
Sponsors
It is an investigator initiated trial
Eligibility
Inclusion criteria
Inclusion criteria: Age more than or equal to 18 years planned to undergo live related donor de novo renal transplantation Participants are willing to comply to the study protocol and provide written informed consent.
Exclusion criteria
Exclusion criteria: Cadaveric renal allograft transplantations Any history of allergy to tacrolimus Patients undergoing multi-organ transplantation Patients harbouring HIV, hepatitis B or C infection Suffering from any malignancy requiring recent surgery Ongoing chemotherapy or radiation Patients suffering from any acute systemic infection within 30 days prior to enrollment Patients who had received any investigational drug within past 6 months Pregnant, nursing mothers or women of childbearing potential without an effective method of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of biopsy-proven acute rejections (BPAR), clinical rejections treated with anti-rejection therapy, delayed graft function, biopsy evidence of CNI toxicity, re-hospitalization due to secondary rise of creatinine or infections, incidence of infections and post-transplant diabetes mellitus (PTDM)Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to reach the recommended therapeutic window (days) in the first 6 weeks of post-transplantation period in both the groups 2. Proportion of patients in the therapeutic window in the post-transplantation period by the end of week 1,2, 3, 4 and 6 weeks in both the groups 3. Time in Therapeutic Range (TIR) in the first 6 weeks of transplantation in both the groups 4. Time to reach baseline creatinine in patients in both the groups 5. Incidence of delayed graft function in both the groups 6. Graft function as measured by eGFR by MDRD formula at discharge and 6 weeks in both the groups 7. Length of hospital stay in both the groups 8. Episodes of BPAR in both the groups 9. The composite of clinical events as mentioned in primary outcome will be assessed at 6, 9 and 12 months. 10. The total cost of treatment in both the groups Timepoint: 6 months, 9 months and 1 year | — |
Countries
India
Contacts
Public ContactSmita Pattanaik
Post Graduate Institute of Medical Education & Research
Outcome results
None listed