A 24-month, 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 inhibitor to everolimus conversion (CRAD001A2429, ELEVATE study)
- Conditions
- niertransplantatierenal transplantation10038430
- Registration Number
- NL-OMON34407
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
At baseline:
* 18 years and above.
* 1st or 2nd renal transplantation from a cadaveric or living unrelated-/related donor.
* Negative pregnancy test (if relevant).
At randomization:
* Use of a CNI (tacrolimus or cyclosporin) plus sodium mycophenolate plus steroids.
* Serum creatinin less than 250 *mol/l and actual eGFR (MDRD4) at least 25 mL/min/1.73 m2
At baseline:
* Recipient of multiple organ transplants.
* Recipient of ABO incompatible allograft or a positive cross-match.
* Patient with current Panel Reactive Antibodies (PRA) level * 30 %.
* HIV, hepatitis B or C (AST/ALT *2,5 x ULN) positive.
* Organ from a HIV or hepatitis B or C positive donor.
* Severe restrictive or obstructive pulmonary disease.
* Severe hypercholesterolaemia of hypertriglyceridaemia.
At randomization:
* Graft loss.
* Renal replacement therapy.
* Serious humoral and/or cellulare rejection.
* 2 or more episodes of acute rejection or an episode that needed antibody treatment.
* Ongoing- or currently treated acute rejection (2 weeks prior to randomization).
* Proteïnuria more than 1 g/day.
* Severe hypercholesterolaemia of hypertriglyceridaemia.
* Impaired would healing.
* Serious immunosuppressive complications or side effects.
* Anticoagulants as contraindication for a renal biopsy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>eGFR after 12 months.</p><br>
- Secondary Outcome Measures
Name Time Method <p>BPAR, graft loss, death, LV mass index (LVMi), other renal function parameters,<br /><br>side effects, cardiovascular events, PK, blood pressure during 24 h, arterial<br /><br>stiffness.</p><br>