Health Condition 1: N19- Unspecified kidney failure
Conditions
Interventions
None listed
Sponsors
Post graduate institute of medical education and research
Eligibility
Inclusion criteria
Inclusion criteria: Aged above 18 years planned to undergoing renal transplantation. Patients willing to participate in the study.
Exclusion criteria
Exclusion criteria: Patients undergoing multi-organ transplantation Patients harboring 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 Use of medications known to affect the tacrolimus pharmacokinetics. Patient refusal from participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To characterize the differences in NFAT-RGE in post-transplant period compared to pre-transplant period in patients with renal transplant.Timepoint: 1. Pre-transplant Period. 2. Post-operative day 7 3. 1 month 4. 3months 5. 6months 6. 12 months 7. in case of any clinical event (rejection and infection) | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. To correlate the change in NFAT-RGE with the time matched tacrolimus C0, pharmacogenetic determinants (CYP3A5 and ABCB1) and clinical events in post-transplantation period. 3. To determine the dose response relationship of tacrolimus for the inhibition of NFAT in-vitro and compare with the response in-vivo. 4. To compare the T and B cell gene expression array in patients with favorable and unfavorable clinical outcome response. Timepoint: Pre-transplant Period. 2. Post-operative day 7 3. 1 month 4. 3months 5. 6months 6. 12 months 7. in case of any clinical event (rejection and infection) | — |
Countries
India
Contacts
Public ContactDr Smita Pattanaik
PGIMER, Chandigarh
Outcome results
None listed