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Study of two different tacrolimus based medicines to see which better prevents liver graft rejection in adults who have received a living donor liver transplant.

Prospective randomized comparative study of graft rejection between Prolonged Release Tacrolimus and Azathioprine vs. Immediate Release Tacrolimus and Mycophenolate Mofetil in Living Donor Liver Transplant recipients - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100127
Enrollment
168
Registered
2026-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: K720- Acute and subacute hepatic failure

Interventions

Intervention1: Prolonged Release Tacrolimus plus Azathioprine : Prolonged release tacrolimus with target trough levels as per institutional liver transplant protocol, in combination with azathioprine

Sponsors

Dr Subhash Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients aged 18 years and above undergoing LDLT. 2. All patients should be receiving Liver from first degree relatives only (grandparents, parents, siblings or children, grandchildren). 3. All patients in which immunosuppression could be commenced within 24 hours of transplant according to study protocol.

Exclusion criteria

Exclusion criteria: 1. All patients with a past history of malignancy other than Liver tumours 2. Simultaneously receiving other organ transplants 3. Serological evidence of HIV positivity 4. ABO incompatible transplants 5. ACLF grade 3 6. Patients with Chronic Kidney Disease planned for sequential or combined kidney transplant 7. Not willing to give consent.

Design outcomes

Primary

MeasureTime frame
Incidence of biopsy proven acute graft rejection after living donor liver transplantation.Timepoint: Assessed during the first 12 months after transplant.—

Secondary

MeasureTime frame
1. Patient and graft survival. 2. Renal function (serum creatinine and estimated glomerular filtration rate). Timepoint: At discharge, 3 months, 6 months, and 12 months after transplant.—

Countries

India

Contacts

Public ContactDr Peush Sahni

Max Super Specialty Hospital

peush.sahni@maxhealthcare.com9999646488

Outcome results

None listed

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