Skip to content

TAADIM LDLT , Trial comparing Tacrolimus based immunosupression in living donor liver transplantation

A single blinded prospective randomised controlled trial on Tacrolimus Vs Advagraf immunosuppression in adult live donor liver transplantation.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/016913
Enrollment
150
Registered
2019-01-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: sustained release tacrolimus given once daily: sustained release tacrolimus given once daily compared against conventional twice daily tacrolimus, Sustained release Tacrolimus 1 mg OD

Sponsors

Amrita Institute of medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients above 18 years 2. Patients who are recipient of primary liver allografts from a living donor. 3. Patients who are capable of understanding and giving written informed consent to be a part of the study.

Exclusion criteria

Exclusion criteria: 1. Deceased donor liver transplant recepients 2. Multiorgan transplants 3. ABO incompatible grafts 4. Recent chemotherapy before transplantation 5. Intolerance to study medications 6. Pediatric transplant

Design outcomes

Primary

MeasureTime frame
1. The primary endpoint is eGFR estimated by CKD-EPI and cystatin clearance at 1,3 and 6 monthsTimepoint: 1,3 and 6 months

Secondary

MeasureTime frame
Biopsy proven acute cellular rejectionTimepoint: Within 6 months post transplant;New onset diabetes mellitus,New onset systemic hypertension and Hypercholesterolemia. Timepoint: Within 6 months post transplant;Post transplant graft function , Patient survival and graft survival, Post transplant infectious complications, Post transplant hospital stay, Post transplant biliary or vascular complications, Incidence of tremor and neurotoxicityTimepoint: Within 6 months post transplant;Serum tacrolimus levels attainedTimepoint: Measured twice weekly in first month, then once in two weeks for next two months and then monthly

Countries

India

Contacts

Public ContactGuhan V

Amrita institute of medical sciences

sudhi@aims.amrita.edu9388623851

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026