| CTRI Number |
CTRI/2023/08/056008 [Registered on: 02/08/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Saroglitazar magnesium in preventing Fatty liver disease in post live donor liver transplant recipients. |
|
Scientific Title of Study
|
Safety and efficacy of Saroglitazar magnesium in live donor liver transplant recipients in preventing Non-alcoholic fatty liver disease (NAFLD): a pilot randomized placebo-controlled trial double- blinded trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhindran S |
| Designation |
Clinical Professor and Chief Transplant Surgeon |
| Affiliation |
Amrita Institute Of Medical Sciences |
| Address |
Department of Gastrointestinal Surgery and Solid Organ Transplantation
Amrita Institute of Medical Sciences, Kochi.
Ernakulam
KERALA
682041
India |
| Phone |
9388623851 |
| Fax |
|
| Email |
sudhi@aims.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhindran S |
| Designation |
Clinical Professor and Chief Transplant Surgeon |
| Affiliation |
Amrita Institute Of Medical Sciences |
| Address |
Department of Gastrointestinal Surgery and Solid Organ Transplantation
Amrita Institute of Medical Sciences, Kochi.
KERALA
682041
India |
| Phone |
9388623851 |
| Fax |
|
| Email |
sudhi@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Valsan |
| Designation |
Assistant Professor |
| Affiliation |
Amrita Institute Of Medical Sciences |
| Address |
Department of Hepatology
Amrita Institute of Medical Sciences, Kochi.
Ernakulam
KERALA
682041
India |
| Phone |
8411051156 |
| Fax |
|
| Email |
drarunvalsan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of GI Surgery, Amrita Institute of Medical Sciences & Research Centre, Ponekkara P.O, Edappally, Kochi, Kerala, India Pin:682041 |
|
|
Primary Sponsor
|
| Name |
Amrita Institute Of Medical Sciences Research Centre |
| Address |
Amrita Institute Of Medical Sciences & Research Centre, PONEKKARA , EDAPPALLY, Kochi, Kerala, India
682041 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sundhindran S |
Amrita Institute Of Medical Sciences |
Department of Gastrointestinal Surgery and Solid Organ Transplantation and Department of Hepatology
Amrita Institute of Medical Sciences, Kochi.
Ernakulam
KERALA |
9388623851
sudhi@aims.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF AMRITA SCHOOL OF MEDICINE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Matched placebo for a period of 24 weeks.
|
| Intervention |
Saroglitazar magnesium |
Saroglitazar 4mg OD 60 minutes before breakfast for 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults>18 <75 years of age.
2. Patients who are at least 6 months post-transplant with normal liver function but are diabetic and have either diabetes mellitus, dyslipidemia and hypertriglyceridemia or obesity
3. History of medical compliance with immunosuppression.
|
|
| ExclusionCriteria |
| Details |
Patient with abnormal transaminases due to
a. Biopsy proven rejection
b. Clinical rejection
c. Vascular complication
d. Biliary complication
Patients with graft dysfunction due to any cause
Body mass index (BMI) <18 kg/m².
History of myopathies or evidence of active muscle diseases.
Unstable cardiovascular disease.
History of bladder disease and/or hematuria or has current hematuria unless due to a urinary tract infection.
Active malignancy post-liver transplantation.
History of malignancy in the past 5 years and/or active neoplasm.
History of chronic rejection of liver transplant graft.
History of alcohol intake.
Subject tests positive for a urine drug screen.
Pregnant or lactating females.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage change in serum ALT |
at week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in ALT by 25% |
by week 24 |
| Treatment emergent adverse events with causality assessment |
by 24 weeks |
| Incremental cost effectiveness ratio (ICER) |
by 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/08/2023 |
| 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
|
To investigate the efficacy of saroglitazar in the prevention of NAFLD in liver transplant recipients who are at high risk of developing NAFLD (diabetes mellitus, dyslipidemia, hypertriglyceridemia, and obesity). |