The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients (EVERKYSTE)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Autosomal Dominant Polycystic Kidney Disease

Treatments: Drug: Everolimus; Drug: Calcineurin inhibitors maintenance

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02134899

2012-004265-41 (EudraCT Number)

P 090804

Details and patient eligibility

About

The investigators multicenter randomized open-labelled study will investigate the efficacy of an everolimus based immunosuppression in reducing total native kidney volume in kidney recipients with autosomal dominant polycystic kidney disease compared to a calcineurin inhibitor-based immunosuppression.

Full description

Kidney graft recipients receiving a firs kidney graft (between 6 months and 5 years post-transplantation) will be randomized 1:1 to receive an everolimus based immunosuppression (in association with steroids and mycophenolate mofetil) or to continue their calcineurin inhibitor-based immunosuppression regimen. The primary objective will be the reduction of total native kidney volume after a 2-years treatment period.

Enrollment: 3 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 18 and 75 years-old
• recipients of a first kidney graft between 6 month and 5 years ago with a stable eGFR above 30 ml/min/1,73m2
• contraception for female recipients to avoid pregnancy
• valid health Insurance during the study period

Exclusion criteria

• signed informed consent not obtained

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Everolimus

Experimental group

Description:

everolimus based immunosuppression

Treatment:

Drug: Everolimus

Calcineurin

Active Comparator group

Description:

Calcineurin inhibitors maintenance

Treatment:

Drug: Calcineurin inhibitors maintenance