Health Condition 1: Z482- Encounter for aftercare followingorgan transplant
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Dr Avinash Ramani
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male, Female & Other gender patients aged 18 years and above. 2. Patients with End-stage Renal Disease (ESRD), who have undergone kidney transplant surgery for the first time, from either a living or a cadaveric donor within 24 hours. 3. Patients / Legally Acceptable Representative who are willing to provide written informed consent. 4. Patients who are willing and able to comply with study procedures and follow-up assessments.
Exclusion criteria
Exclusion criteria: 1. Patients with history of prior renal transplantation. 2. Patients with combined transplants of two organs. 3. Patients having transplant from a monozygotic/identical twin. 4. Patients with other clinical conditions and co-morbidities viz., malignancy, previous or active graft failure or active infection etc., which as per the investigator would jeopardize the outcome of the trial. 5. Patients currently participating in another clinical/investigational study. 6. Patients who, in the opinion of the investigator, are unlikely to comply with the study protocol or follow-up requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Diagnostic Test Measures like Sensitivity, specificity, Positive and Negative predictive values of the Trunome assay in detecting graft rejection as confirmed by biochemical assays and conventional tissue biopsy will be provided along with 95 percent confidence interval. ROC curves will be used to compare the diagnostic abilities of Trunome assay and conventional tissue biopsy. Timepoint: Visit 1- Baseline (after 24 hours), Visit 2- (Day 3), Visit 3-(Day 7), Visit 4(Day 30), Visit 5 (Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| ROC curves will be used to compare the diagnostic abilities of the cfDNA, ddcfDNA & T-Cell Apoptotic marker levels against serum creatinine levels in patients with stable graft function Vs patients experiencing graft rejection. Spearmans correlation with biopsy, exclusively in patients undergoing biopsy, will be provided along with 95percent confidence interval.Timepoint: Visit 1- Baseline (after 24 hours), Visit 2- (Day 3), Visit 3-(Day 7), Visit 4(Day 30), Visit 5 (Day 90) | — |
Countries
India
Contacts
Public ContactBrindha Arumugam
iDD Research Solutions Pvt. Ltd.
Outcome results
None listed