A multicenter, open-label, Prospective, randomized parallel group Phase III study investigating the benefit on Renal function of a CNI-free regimen with MyfOrtic® (mycophenolate sodium) and Certican® (everolimus) in coMparison to therapy with CErTican® (everolimus) and Prograf® (tacrolimus) in de novo rEnal transplant patients at 12 months post transplantatio
- Conditions
- Kidney transplantationTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2013-001798-26-FR
- Lead Sponsor
- CHU DE POITIERS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 390
1)Males or females, aged = 18 years and = 65 years
2)End stage kidney disease and a suitable candidate for primary renal transplantation
3)Receiving a kidney transplant from a deceased or living donor
4)Female capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 8 weeks following discontinuation of study medication even where there has been a history of infertility
5)Total ischemia time below 30 hours.
6)Patients able to receive a first dose of tacrolimus and everolimus in the 24 hours following the reperfusion of the transplant.
7)Capable of understanding the purpose and risks of the study.
8)Fully informed and having given written informed consent (signed Informed Consent has been obtained).
9)Affiliation to the social security regimen
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 390
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1)More than one previous renal transplantation
2)Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ, different from kidney
3)Patients receiving a kidney from a non-heart beating donor
4)Patients who are recipients of A-B-O incompatible transplants
5)Patients who are HIV positive or Hepatitis B surface antigen positive or Hepatitis C virus positive. Recipients of organs from donors with positive test for Hepatitis B surface antigen or Hepatitis C are excluded.
6)Patients who have been treated with one of the study drug for 4 weeks before Everolimus administration.
7)Patients with clinically significant infection requiring continued therapy which would interfere with the objectives of the study
8)TGI > 50%
9)Known allergy or contraindication to everolimus, tacrolimus, mycophenolic acid, basiliximab, corticosteroids or any of the product excipients.
10)Evidence of severe liver disease (incl. abnormal liver enzyme profil, i.e. AST, ALT or total bilirubin > 3 times UNL)
11)Severe hyperlipidemia defined by: total cholesterol = 9,1 mmol/L (= 350 mg/dL) and/or hypertriglyceridemia = 5,6 mmol/l (= 500 mg/dL)
12)Patients with leucopenia (leucocytes = 3000 / mm3) or thrombocytopenia (platelets = 75000/mm3)
13)Patients having cicatrisation problems.
14)Patients suffering from a peptic ulcer.
15)Currently participating in another clinical trial, and/or has taken an investigational drug within four weeks prior to enrollment.
16)Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
17)Unlikely to comply with the visits scheduled in the protocol.
18)Patients with a diagnosed cancer or history of cancer (except for basal-cell carcinoma) within 5 years prior to enrollment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effects on the renal function at 12 months post-transplant, of a CNI free therapeutic strategy switching Prograf to Mycophenolic Acid at Month 3, in patients treated with a CNI combined Prograf and Everolimus regimen within the first 3 months after transplantation.;Secondary Objective: Patient and graft survival rate<br>Rejection.rate.<br>Occurrence of side effects.<br>Early discontinuation.<br>To assess by a differential proteomic approach (iTRAQ) the evolution of urinary biomarkers of tacrolimus nephrotoxicity before and after tacrolimus withdrawal<br>;Primary end point(s): Renal function assessed as glomerular filtration rate (GFR) – MDRD method.;Timepoint(s) of evaluation of this end point: 12 MONTHS
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • survival without rejection.<br>Patient and graft survival rate <br>To assess acute rejection rate .<br>• To assess de novo Donor specific HLA antibody (DSA) occurrence<br>• To assess occurrence of treatment failure up to or at Month 12, treatment failure being defined as a composite endpoint of biopsy proven acute rejection, graft loss, death, loss to follow up (at least one condition must be present)<br><br>SAFETY criteria<br>• To assess renal function <br>• To assess evolution of renal function Side effects such as:<br>• The proportion of patients with occurrence of New Onset Diabetes Mellitus as defined by American Diabetic Association (ADA) criteria <br><br>;Timepoint(s) of evaluation of this end point: Patient and graft survival rate at 12 months.<br>Rejection rates at 3 months and 12 months.<br>Renal function at 12 months.<br>DSA rate at 3, 6 and 12 months.<br>Side effects at each visit.<br>