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

NCT ID: NCT02134899

Last Updated: 2018-12-10

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.

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

Keywords

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Autosomal dominant polycystic kidney disease cyst kidney liver kidney transplantation IF/TA fibrosis DSA mTOR inhibitors calcineurin inhibitors

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

Exclusion Criteria

* signed informed consent not obtained
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hélène François, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Bicêtre Hospital

Le Kremlin-Bicêtre, , France

Site Status

Countries

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France

Other Identifiers

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2012-004265-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P 090804

Identifier Type: -

Identifier Source: org_study_id