FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2014/07/004772 [Registered on: 25/07/2014] Trial Registered Retrospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the graft function of everolimus and reduced Calcineurin Inhibitor versus mycophenolic acid sodium and standard Calcineurin Inhibitor in adult renal transplant recipients.  
Scientific Title of Study   A 24 month, multicenter, randomized, open-label safety and efficacy study of concentration-controlled everolimus with reduced calcineurin inhibitor vs mycophenolate with standard calcineurin inhibitor in de novo renal transplantation- Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CRAD001A2433 dated 01-Jul-2013  Protocol Number 
NCT01950819  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Murugananthan K 
Designation  Head-Clinical Development 
Affiliation  Head Clinical Development in Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited, Medical Department, Sandoz House,Shiv Sagar Estate,Dr.Annie Besant Road, Worli, Mumbai.

Mumbai
MAHARASHTRA
400 018
India 
Phone  022-24958545  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Scientific Query  
Name  Murugananthan K 
Designation  Head-Clinical Development 
Affiliation  Head Clinical Development in Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited, Medical Department, Sandoz House,Shiv Sagar Estate,Dr.Annie Besant Road, Worli, Mumbai.

Mumbai
MAHARASHTRA
400 018
India 
Phone  022-24958545  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Public Query  
Name  Murugananthan K 
Designation  Head-Clinical Development 
Affiliation  Head Clinical Development in Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited, Medical Department, Sandoz House,Shiv Sagar Estate,Dr.Annie Besant Road, Worli, Mumbai.

Mumbai
MAHARASHTRA
400 018
India 
Phone  022-24958545  
Fax    
Email  murugananthan.k@novartis.com  
 
Source of Monetary or Material Support  
Novartis Pharma AG, Basel, Switzerland. 
 
Primary Sponsor  
Name  Novartis Healthcare Private Limited 
Address  Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli,Mumbai – 400 018. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Belgium
Czech Republic
Egypt
Germany
India
Italy
Netherlands
Slovakia
South Africa
Spain
Switzerland  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shibu Jacob  Christian Medical College  Department of Nephrology, Ida Scudder Road, Vellore, Tamil Nadu - 632004
Vellore
TAMIL NADU 		 919952450504
04162282714
jacobshibu@gmail.com 
Dr Sundar Sankaran  Columbia Asia Referral Hospital  Department Of Nephrology,Yeshwanthpur,26/1,Brigade Gateway, Malleshwaram W-560055
Bangalore
KARNATAKA 		 918039898969
918030925688
ssundar99@hotmail.com 
Dr Dinesh Khullar  Max Super specialty Hospital  Department of Nephrology, Max Super specialty Hospital, A Unit Of Devki Devi Foundation,(East Block) 1,Press Enclave Road, Saket, New Delhi, 110017
New Delhi
DELHI 		 919810124066

drdineshkhullar@gmail.com 
Dr Manisha Sahay  Osmania General Hospital  Department of Nephrology, 3rd Floor, QQDC Building, Afzalgunj, Hyderabad 500012
Hyderabad
ANDHRA PRADESH 		 919849097507
91-40-24616687
drmanishasahay@gmail.com 
Dr Alan Almeida  P.D.Hinduja Hospital & MRC  Deprtment of Nephrology, Veer Savarkar Marg,Mahim,Mumbai-16
Mumbai
MAHARASHTRA 		 9619726888

almeidaa@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
clinical research Ethics Committee  Approved 
Ethics Committee & Institutional Review Board (IRB)_christian Medical College  Approved 
Ethics Committee,Osmania Medical College  Submittted/Under Review 
Institutional Ethics Committee_Columbia Asia Referral Hospital  Approved 
Institutional Ethics committee_Max Healthcare superspeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  •End Stage Renal Disease (ESRD) •Chronic Kidney Disease (CKD) •Hemodialysis •Renal Replacement Therapy •Renal Transplantation ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Everolimus and reduced calcineurin inhibitor   Everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus) inhibitor. All subjects are to receive maintenance therapy with corticosteroids and induction therapy.[Total Duration is 24 months] [Route of administration is Oral][frequency of drug- daily]  
Comparator Agent  Standard dose of CNI tacrolimus/cyclosporine) and Mycophenolate   Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus). All subjects are to receive maintenance therapy with corticosteroids and induction therapy.[Total Duration is 24 months] [Route of administration is Oral][frequency of drug- daily]  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Written informed consent obtained.
2.Subject randomized within 24 hr of completion of transplant surgery.
3.Recipient of a kidney with a cold ischemia time < 30 hours.
4.Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased heart beating, living unrelated, living related non-human leukocyte antigen identical or an expanded criteria donor.
 
 
ExclusionCriteria 
Details  1.Subject unable to tolerate oral medication at time of randomization.
2.Use of other investigational drugs at the time of enrollment.
3.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
4.Multi-organ transplant recipient.
5.Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant.
6.Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity e.g. high PRA, presence of pre-existing DSA.
7.Subject who is HIV-positive.
8.HBsAg and/or a HCV positive subject with evidence of elevated LFTs (ALT/AST levels ≥ 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable.
9.Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV).
10.Subject with a BMI greater than 35.
11.Subject with severe systemic infections, current or within the two weeks prior to randomization.
12.Subject requiring systemic anticoagulation.
13.History of malignancy of any organ system.
14.Subject with severe restrictive or obstructive pulmonary disorders.
15.Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled.
16.Subject with white blood cell (WBC) count ≤ 2,000 /mm3 or with platelet count ≤ 50,000 /mm3.
17.Pregnant or nursing (lactating) women.
18.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR)less than 50 mL/min/1.73m2.
 		 Month 12 is Primary,Month 24 secondary  
 
Secondary Outcome  
Outcome  TimePoints 
1)Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death
2)Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR less than 50 mL/min/1.73m2
3)Incidence of failure on the composite endpoint of graft loss or death
4)Incidence of death, graft loss, tBPAR, BPAR, tAR, AR and humoral rejection.
 		 1)Time Frame: Month 12 and 24
2)Time Frame: Month 12 and 24
3)Time Frame: Month 12 and 24
4)Time Frame: Month 12 and 24
 
1)Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death
2)Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR less than 50 mL/min/1.73m2
3)Incidence of failure on the composite endpoint of graft loss or death
4)Incidence of death, graft loss, tBPAR, BPAR, tAR, AR and humoral rejection.
 		 1)Time Frame: Month 12 and 24
2)Time Frame: Month 12 and 24
3)Time Frame: Month 12 and 24
4)Time Frame: Month 12 and 24
 
 
Target Sample Size   Total Sample Size="1972"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "2037"
Final Enrollment numbers achieved (India)="38" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   03/03/2014 
Date of Study Completion (India) 20/12/2017 
Date of First Enrollment (Global)  02/12/2013 
Date of Study Completion (Global) 15/01/2018 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   No Publications provided. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

i] Purpose of the Trial - The purpose of the trial is to demonstrate the efficacy and safety of Everolimus in combination with reduced CNI,compared to MPA and standard CNI, in living donor Renal transplant recepients.

ii] FVFV for India - 03-Mar-2014.

iii] Target Sample Size for India - 150

 
Close