| CTRI Number |
CTRI/2018/07/014916 [Registered on: 17/07/2018] Trial Registered Prospectively |
| Last Modified On: |
28/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A prospective, phase IV study to check the effectiveness and safety of everolimus in liver transplant in Indian patients |
|
Scientific Title of Study
|
A prospective, phase IV study to evaluate the efficacy and safety of everolimus in liver transplant in Indian patients |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CRAD001AIN06 Version 03 Dated 16 Jun 2020 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Noopur Vyas |
| Designation |
Medical Lead |
| Affiliation |
Novartis India Limited |
| Address |
Novartis Healthcare Pvt. Ltd.
The Inspire – BKC,
7th Floor, G-Block, BKC Main Road,
Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022-50243000 |
| Fax |
|
| Email |
noopur_ajaykumar.vyas@novartis.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Noopur Vyas |
| Designation |
Medical Lead |
| Affiliation |
Novartis India Limited |
| Address |
Novartis Healthcare Pvt. Ltd.
The Inspire – BKC,
7th Floor, G-Block, BKC Main Road,
Bandra Kurla Complex, Bandra East, Mumbai,
Maharastra
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02250243000 |
| Fax |
|
| Email |
noopur_ajaykumar.vyas@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Noopur Vyas |
| Designation |
Medical Lead |
| Affiliation |
Novartis India Limited |
| Address |
Novartis Healthcare Pvt. Ltd.
The Inspire – BKC,
7th Floor, G-Block, BKC Main Road,
Bandra Kurla Complex, Bandra East, Mumbai,
Maharastra
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
02250243000 |
| Fax |
|
| Email |
noopur_ajaykumar.vyas@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Healthcare Pvt Ltd |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis India Limited |
| Address |
Novartis Healthcare Pvt. Ltd.
The Inspire – BKC,
7th Floor, G-Block, BKC Main Road,
Bandra Kurla Complex, Bandra East, Mumbai,
Maharastra- 400051
India
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Novartis India Limited |
Novartis Healthcare Pvt. Ltd.
The Inspire – BKC,
7th Floor, G-Block, BKC Main Road,
Bandra Kurla Complex, Bandra East, Mumbai,
Maharastra- 400051
India
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSSudhindran |
Amrita Institute of Medical Sciences and Research Centre |
Amrita Institute of medical sciences & research, AIMS, ponekkara,P.O, kochi 682041
Ernakulam
KERALA |
9388623851
sudhi@aims.amrita.edu |
| Dr L Sasidhar Reddy |
Apollo Hospitals |
Apollo hospitals, Jubilee Hills, Hyderabad, Telangana 500096, India
Hyderabad
TELANGANA |
7838046417
drshashi2708@gmail.com |
| DrAnand Khakhar |
Apollo Hospitals |
21, Greams Lane, OFF Greams Roads, Chennai-600006
Chennai
TAMIL NADU |
9952099499
anandkhakhar@gmail.com |
| Dr Giriraj Bora |
Artemis hospital |
Artemis hospital, sector-51, Gurugram-122001
Gurgaon
HARYANA |
9873708979
giriraj.bora@artemishospitals.com |
| Dr Abhideep Chaudhary |
BLK Super Speciality hospital |
BLK Super Speciality hospital, BLK Super Speciality hospital department of HPB & liver Transplantation, Pusa Road, New Delhi – 110005
New Delhi
DELHI |
9871859776
abhideep.chaudhary@blkhospital.com |
| Dr Chandan Kumar |
Gleneagles Global Hospitals |
Gleneagles Global Hospitals, 6-1-1070/1 to 4, Lakdi- ka- pul, Hyderabad, Telangana, India- 500004
Hyderabad
TELANGANA |
8754919777
drchandankn@gmail.com |
| DrRavi Mohanka |
Global Hospitals |
Global Hospitals ,Room No 204,2nd Floor,35Dr.E.Borges Road,Hospital Avenue, ,Parel Mumbai-400012
Mumbai
MAHARASHTRA |
7506668666
ravimohanka@globalhospitalsindia.com |
| DrVinay Kumaran |
Kokilaben Dhiribhai Ambani Hospital & Medical Research Institute |
Kokilaben Dhiribhai Ambani Hospital & Medical Research Institute
Raoasaheb Achutrao patwardhan Marg,
Four Bunglow, Andheri West,
Mumbai 400053
Mumbai
MAHARASHTRA |
02230972030
vinay.kumaran@relianceada.com |
| DrNeeraj Saraf |
Medanta-The Medicity |
Medanta- The Medicity, Sector-38, Gurgaon,Haryana
Gurgaon
HARYANA |
9899077795
neeraj.saraf@medanta.org |
| Dr Sheetal Mahajani |
Sahyadri Super Speciality Hospital |
Sahyadri Super Speciality Hospital, A unit of Sahyadri Hospitals Limited, 30C, Erandwane, Karve Road, Pune - 411004
Pune
MAHARASHTRA |
9822912080
drsheetalmahajani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences Institutional Ethics Committee |
Approved |
| Institute ethics committee gleneagles global hospital |
Approved |
| Institute of Ethics Committee (IEC), BLK hospital, Delhi |
Approved |
| Institutional Ethics Committee Clinical studies, Apollo medical college, Hyderabad |
Approved |
| Institutional Ethics Committee Global Hospital,Mumbai |
Approved |
| Institutional Ethics Committee Sahyadri hospital |
Approved |
| Institutional Ethics CommitteeAmrita Institute of medical sciences & research |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Liver Transplant, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Everolimus |
efficacy and safety of everolimus |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age above 18 years of age.
Patients willing to participate in the study by providing written informed consent
Liver transplant recipient who will be receiving everolimus for the first time as per the prescribing information within six months post liver transplant.Patients should be receiving at least tacrolimus ± steroid at the time of baseline. Allograft function acceptable at time of screening as defined by AST, ALT and total bilirubin < 3 times ULN.
|
|
| ExclusionCriteria |
| Details |
Contraindication as per Prescribing information .
ABO incompatible transplant.
Use of Mycophenolic acid (MPA) after baseline visit
Use of other investigational drugs at screening, or within 30 days or 5 half-lives of screening, whichever is longer.
Patient with estimated GFR < 40 /min/1.73 m2 (MDRD -4) measured anytime within one month before baseline visit.Subjects receiving multiple solid organ (including multiple liver lobes/segments) or islet cell tissue transplants, or have previously received an organ or tissue transplant
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate renal function over time in liver transplant recipients after introduction of everolimus, measured by estimated glomerular filtration rate (eGFR by MDRD -4 formula) from baseline visit to month 12. |
From Day 0 till Month 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate Acute Rejection treated Acute Rejection Biopsy-confirmed Acute Rejection treated Biopsy-confirmed Acute Rejection at 6 month and 12 month.
To evaluate incidence of Graft Loss and Death at 6 month and month 12.
|
6 month and 12 month |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
31/08/2018 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Everolimus has been approved globally across various countries for renal, hepatic and cardiac transplantation.
In India health authority (HA) has mandated to conduct phase IV study in Indian patients as a part of approval to marketing authorization of everolimus in liver transplant.
Thus the present observational study is planned to evaluate the efficacy and safety of everolimus in the routine clinical practice in liver transplantation in Indian patients
|