Evaluation of pharmacodynamics biomarkers in patients undergoing renal transplantation and their impact on the outcome
Not Applicable
- Conditions
- Health Condition 1: N19- Unspecified kidney failure
- Registration Number
- CTRI/2023/03/050824
- Lead Sponsor
- Post graduate institute of medical education and research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Aged above 18 years planned to undergoing renal transplantation.
Patients willing to participate in the study.
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>2. Post-operative day 7 <br/ ><br>3. 1 month <br/ ><br>4. 3months <br/ ><br>5. 6months <br/ ><br>6. 12 months <br/ ><br>7. in case of any clinical event (rejection and infection)
- Secondary Outcome Measures
Name Time Method 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. <br/ ><br> <br/ ><br>3.To determine the dose response relationship of tacrolimus for the inhibition of NFAT in-vitro and compare with the response in-vivo. <br/ ><br>4. To compare the T and B cell gene expression array in patients with favorable and unfavorable clinical outcome response. <br/ ><br> <br/ ><br>Timepoint: Pre-transplant Period. <br/ ><br>2. Post-operative day 7 <br/ ><br>3. 1 month <br/ ><br>4. 3months <br/ ><br>5. 6months <br/ ><br>6. 12 months <br/ ><br>7. in case of any clinical event (rejection and infection)