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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-14

Study Completion Date

2017-11-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autosomal Dominant Polycystic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Everolimus

everolimus based immunosuppression

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Change from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression

Calcineurin

Calcineurin inhibitors maintenance

Group Type ACTIVE_COMPARATOR

Calcineurin inhibitors maintenance

Intervention Type DRUG

Usual treatment

Interventions

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Everolimus

Change from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression

Intervention Type DRUG

Calcineurin inhibitors maintenance

Usual treatment

Intervention Type DRUG

Other Intervention Names

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everolimus conversion calcineurin-inhibitors based immunosuppression

Eligibility Criteria

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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