Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
EUCTR |
Last refreshed on:
|
26 February 2018 |
Main ID: |
EUCTR2013-000322-66-BE |
Date of registration:
|
13/11/2013 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
This study CRAD001A2433 is designed to evaluate the impact of concentration-controlled everolimus with reduced exposure CNI, compared to mycophenolic acid (MPA) with standard exposure CNI, with respect to efficacy and safety in de novo renal transplant recipients.
|
Scientific title:
|
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 (TRANSFORM) - Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen (TRANSFORM) |
Date of first enrolment:
|
20/01/2014 |
Target sample size:
|
2240 |
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000322-66 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
|
|
Countries of recruitment
|
Argentina
|
Australia
|
Austria
|
Belgium
|
Brazil
|
Bulgaria
|
Colombia
|
Croatia
|
Czech Republic
|
Egypt
|
France
|
Germany
|
Greece
|
Guatemala
|
India
|
Indonesia
|
Italy
|
Japan
|
Jordan
|
Korea, Republic of
|
Kuwait
|
Lebanon
|
Malaysia
|
Mexico
|
Netherlands
|
Norway
|
Panama
|
Philippines
|
Poland
|
Portugal
|
Russian Federation
|
Saudi Arabia
|
Singapore
|
Slovakia
|
Slovenia
|
South Africa
|
Spain
|
Sweden
|
Taiwan
|
Thailand
|
Turkey
|
United States
|
Venezuela, Bolivarian Republic of
| | | | | |
Contacts
|
Name:
|
Clinical Trial Information Desk
|
Address:
|
Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
|
+41613241111 |
Email:
|
clinicaltrial.enquiries@novartis.com |
Affiliation:
|
Novartis Pharma AG |
|
Name:
|
Clinical Trial Information Desk
|
Address:
|
Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
|
+41613241111 |
Email:
|
clinicaltrial.enquiries@novartis.com |
Affiliation:
|
Novartis Pharma AG |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2040 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria: 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 similar chemical classes.
4. multi-organ transplant recipient
5. Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant
6. high immunological risk by assessment of anti-donor reactivity e.g. high PRA, presence of pre-existing DSA
7. HIV positive
8. HBsAg and/or a HCV positive with evidence of elevated LFTs (ALT/AST levels = 2.5 times ULN)
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. BMI greater than 35
11. severe systemic infections
12. Subject requiring systemic anticoagulation
13. History of malignancy
14. severe restrictive or obstructive pulmonary disorders
15. severe hypercholesterolemia or hypertriglyceridemia
16. 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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
Adult kidney transplant recipients. MedDRA version: 20.0
Level: PT
Classification code 10064848
Term: Chronic kidney disease
System Organ Class: 10038359 - Renal and urinary disorders
|
Therapeutic area: Body processes [G] - Immune system processes [G12]
|
Intervention(s)
|
Trade Name: Certican Product Name: Certican 0.25mg Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus CAS Number: 159351-69-6 Current Sponsor code: RAD001 Other descriptive name: EVEROLIMUS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25-
Trade Name: Certican Product Name: Certican 0.5mg Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus CAS Number: 159351-69-6 Current Sponsor code: RAD001 Other descriptive name: EVEROLIMUS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.50-
Trade Name: Certican Product Name: Certican 0.75mg Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus CAS Number: 159351-69-6 Current Sponsor code: RAD001 Other descriptive name: EVEROLIMUS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.75-
Trade Name: Myfortic 180 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MYCOPHENOLIC ACID CAS Number: 24280-93-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 180-
Trade Name: Myfortic 360 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MYCOPHENOLIC ACID CAS Number: 24280-93-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 360-
Trade Name: Cellcept 250 mg capsules Pharmaceutical Form: Capsule Other descriptive name: MYCOPHENOLATE MOFETIL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250-
Trade Name: Cellcept 500 mg film-coated tablets Pharmaceutical Form: Film-coated tablet Other descriptive name: MYCOPHENOLATE MOFETIL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500-
|
Primary Outcome(s)
|
Primary end point(s): The primary analysis will be performed on the Full Analysis Set following the intent-to-treat principle. The primary endpoint of tBPAR or eGFR (MDRD4) < 50 mL/min/1.73m2 at Month 12 will be tested at the significance level of 0.05. Event rates will be compared between groups using a 2-stage approach (hierarchical testing strategy). First, noninferiority of EVR plus reduced CNI vs. MPA plus standard CNI will be evaluated using a 10% non-inferiority margin. If this is significant, then superiority will be evaluated. Based on the closed testing principle, no multiplicity adjustment will be made for testing for both non-inferiority and superiority.
|
Secondary Objective: •composite efficacy failure rate [treated biopsy proven acute rejection(tBPAR), graft loss(GL) or death(D)] at M12 •composite endpoint(cEP)of tBPAR or eGFR<50 mL/min/1.73m2 (MDRD4) M12 among compliers •cEPof tBPAR or eGFR<50 mL/min/1.73m2 at M24 •cEP of tBPAR (excluding Banff 1A) or eGFR<50 mL/min/1.73m2 at M24 •cEP of tBPAR or eGFR<50 mL/min/1.73m2 at M12 by subgroup •cEP of tBPAR, GL, D, or loss to follow-up at M12/24 •cEP of tBPAR, GL, D or eGFR<50 mL/min/1.73m2 at M12/24 •individual endpoints of D, GL, tBPAR, BPAR, tAR, AR and humoral rejection at M12/24 •tBPAR by severity and time to event and also excluding excluding Banff 1A •Tx recipients with eGFR<50 mL/min/1.73m2 at M12/24 •RF and change from M1(eGFR) at M12/24 and over time by slope analysis and by Cystatin C-based and other formulae •AEs, SAEs and AEs leading to study drug discontinuation •CMV and BKV, NODM, CKD with associated proteinuria and CNI associated AE •Urinary protein/albumin excretion
|
Main Objective: Evaluate the effect of everolimus with reduced exposure CNI versus MPA with standard exposure CNI on the binary composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50 mL/min/1.73m2 (estimated glomerular filtration rate by MDRD4 formula) at Month 12 post-transplantation.
|
Timepoint(s) of evaluation of this end point: At 12-month after transplantation.
|
Secondary Outcome(s)
|
Timepoint(s) of evaluation of this end point: At 12-month after transplantation.
|
Secondary end point(s): With respect to the key secondary endpoint - composite efficacy failure of tBPAR, graft loss or death at Month 12, non-inferiority of EVR plus reduced CNI vs. MPA plus standard CNI will be evaluated at the significance level of 0.05 using a 10% non-inferiority margin based on the Full Analysis Set.
To evaluate the binary composite endpoint of tBPAR or eGFR < 50 mL/min/1.73m2 (MDRD4) Month 12 among compliant subjects.
|
Secondary ID(s)
|
2013-000322-66-DE
|
CRAD001A2433
|
Source(s) of Monetary Support
|
Novartis Pharma Services AG
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|