| CTRI Number |
CTRI/2026/01/100127 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Subhash Gupta |
| Designation |
Chairman CLBS |
| Affiliation |
Max Super Specialty Hospital |
| Address |
CLBS office, 5th floor, West wing, Max Super Specialty Hospital, 1 2, Press Enclave Marg, Saket Institutional Area, Saket, New Delhi, Delhi 110017
South
DELHI
110017
India |
| Phone |
9811075683 |
| Fax |
|
| Email |
drSubhash.Gupta@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Peush Sahni |
| Designation |
Senior Consultant, Academic Head, CLBS |
| Affiliation |
Max Super Specialty Hospital |
| Address |
CLBS office, 5th floor, West wing, Max Super Specialty Hospital, 1 2, Press Enclave Marg, Saket Institutional Area, Saket, New Delhi, Delhi 110017
South
DELHI
110017
India |
| Phone |
9999646488 |
| Fax |
|
| Email |
peush.sahni@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Peush Sahni |
| Designation |
Senior Consultant, Academic Head, CLBS |
| Affiliation |
Max Super Specialty Hospital |
| Address |
CLBS office, 5th floor, West wing, Max Super Specialty Hospital, 1 2, Press Enclave Marg, Saket Institutional Area, Saket, New Delhi, Delhi 110017
DELHI
110017
India |
| Phone |
9999646488 |
| Fax |
|
| Email |
peush.sahni@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Subhash Gupta |
| Address |
CLBS office, 5th floor, West Wing, Max Super Specialty Hospital, 1 2, Press EnclaveInstitutional Area, Saket, New Delhi, Delhi 110017 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subhash Gupta |
Max Super Specialty Hospital |
CLBS office, 5th floor, West Wing, Max Super Specialty Hospital, 1 2, Press Enclave Institutional Area, Saket, New Delhi, Delhi 110017
South
DELHI |
9811075683
drSubhash.Gupta@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K720||Acute and subacute hepatic failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Immediate Release Tacrolimus plus Mycophenolate Mofetil
|
Immediate release tacrolimus with target trough levels as per institutional liver transplant protocol, in combination with mycophenolate mofetil, initiated within 24 hours after living donor liver transplant and continued as per study schedule. |
| Intervention |
Prolonged Release Tacrolimus plus Azathioprine
|
Prolonged release tacrolimus with target trough levels as per institutional liver transplant protocol, in combination with azathioprine, initiated within 24 hours after living donor liver transplant and continued as per study schedule |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of biopsy proven acute graft rejection after living donor liver transplantation. |
Assessed during the first 12 months after transplant.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Patient and graft survival.
2. Renal function (serum creatinine and estimated glomerular filtration rate).
|
At discharge, 3 months, 6 months, and 12 months after transplant.
|
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single centre, prospective, randomized, open label, phase 4
clinical trial in adult living donor liver transplant recipients. The study
will compare two tacrolimus based immunosuppressive regimens. One group will
receive prolonged release tacrolimus with azathioprine. The other group will
receive immediate release tacrolimus with mycophenolate mofetil. The primary
objective is to compare the incidence of biopsy proven acute graft rejection in
the first year after transplant. Secondary objectives include comparison of
patient and graft survival, renal function, and serious infections during
follow up. |