A 24 months, multi-center, open-label, randomized, controlled trial to investigate efficacy, safety and evolution of cardiovascular parameters in de novo renal transplant recipients after early calcineurin nhibitor to everolimus conversion.
- Conditions
- renal transplantationMedDRA version: 14.1Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 10042613 - Surgical and medical procedures
- Registration Number
- EUCTR2009-015918-22-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 676
Inclusion criteria at Baseline: (Day of transplantation) • Male or female renal allograft recipients at least 18 years old. • Patients who have given written informed consent to participate in the study. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness. • Patient who has received a primary or secondary kidney transplant from a cadaveric or living unrelated-/related donor. • Recipient of a kidney allograft with a cold ischemia time (CIT) < 24 hours. • Female patients must have a negative pregnancy test prior to study enrollment. Inclusion criteria at Randomization: (Week 10-14 after transplantation) • Patients on CNI (tacrolimus or Neoral) + Myfortic + steroids. • Patients with an acceptable allograft function defined by a serum creatinine < 2.8 mg/dL (250 µmol/L) and an actual eGFR (MDRD4) = 25 mL/min/1.73m2 (without renal replacement therapy).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria at Baseline: (Day of transplantation) • Recipient of multiple organ transplants. • Recipient of ABO incompatible allograft or a positive cross-match. • Patient with most recent Panel Reactive Antibodies (PRA) level = 30 % or a positive luminex test for any permitted antigen of the recipient. • Patient who is human immunodeficiency virus (HIV) positive. • Patient who received an allograft from a Hepatitis B surface Antigen (HBsAg) or a Hepatitis C Virus (HCV) positive donor. • HBsAg and/or a HCV positive patient with evidence of elevated LFTs (ALT/AST levels = 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable. • Patient with severe restrictive or obstructive pulmonary disorders. • Patient with severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment that would prevent patient from potential exposure to everolimus, or with hypersensitivity to drugs similar to everolimus (e.g. macrolides). • Patients with a known hypersensitivity/contraindication to any of the immunosuppressants or their classes, or to any of the excipients. • Patient with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled. • Patient with white blood cell (WBC) count = 2,000 /mm3 or with platelet count = 50,000 /mm3. • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. Exclusion criteria at Randomization: (Week 10-14 after transplantation) • Graft loss. • Patient on renal replacement therapy. • Patient who experienced severe humoral and/or cellular rejection (BANFF = IIb). • Patient with = 2 episodes of AR or an AR episode that needed antibody treatment. • Patient with ongoing or currently treated AR (2 weeks prior to randomization). • Proteinuria > 1 g/day (as calculated from the urinary protein-to-creatinine ratio). • Patients with recurrence of Focal Segmental Glomerulosclerosis (FSGS). • Patient with white blood cell (WBC) count = 2,000 /mm3, an absolute neutrophil count of = 1,500 /mm3, with a platelet count = 50,000 /mm3, or hemoglobin < 8 g/dL. • Evidence of severe liver disease (incl. abnormal liver function tests, i.e. AST, ALT or total bilirubin > 2.5 times ULN). • Patient who has a current severe systemic infection according to the investigator judgment requiring continued therapy that would interfere with the objectives of the study. • Patient with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled. • Patients with ongoing wound healing problems, clinically significant infection requiring continued therapy or other severe surgical complication in the opinion of the investigator. PLS SEE PROTOCOL
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method