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)

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) - ELEVATE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34407

Enrollment

Registered

2010-06-21

Start date

2010-09-29

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

niertransplantatie renal transplantation

Interventions

Conversion from CNI to everolimus or continuation of CNI.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
eGFR after 12 months.	—

Secondary

Measure	Time frame
BPAR, graft loss, death, LV mass index (LVMi), other renal function parameters, side effects, cardiovascular events, PK, blood pressure during 24 h, arterial stiffness.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)