Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

Poitiers University Hospital

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease

Treatments: Drug: Mycophenolate sodium; Drug: Everolimus; Drug: Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT02334488

PROMéTé

Details and patient eligibility

About

Prospective, multicenter, randomized and open label study evaluating the benefit on renal function at 12 months post-transplantation, with an immunosuppression without calcineurin inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.

Enrollment: 329 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients receiving a first kidney transplant from a cadaveric or living donor

Exclusion criteria

• Double transplant
• Patient who has been treated with an immunosuppressive drug or study drug during the four weeks before administration of the first dose of Everolimus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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329 participants in 2 patient groups

Everolimus-Tacrolimus

Active Comparator group

Description:

* Tacrolimus (Prograf®) started at 0,1 mg/kg/day since Day0, then adapted to C0 concentration (4-7 ng/ml), * Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml).

Treatment:

Drug: Tacrolimus

Drug: Everolimus

Everolimus-Mycophenolate sodium

Experimental group

Description:

* Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml), * Tacrolimus (Prograg®) started at 0,1 mg/kg/day from J0 then to be adapted to C0 concentration (4-7 ng/ml), then replacement by mycophenolate sodium (Myfortic®) at M3 (3 months visit) started at 1440 mg/day.

Treatment:

Drug: Everolimus

Drug: Mycophenolate sodium