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

Phase 3

Completed

• Conditions: Autosomal Dominant Polycystic Kidney Disease
• Interventions: Drug: Calcineurin inhibitors maintenance; Drug: Everolimus

• Registration Number: NCT02134899
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-09
• Study Start: 2014-10-14
• Primary Completion: 2017-11-11
• Study Completion: 2017-11-11
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-07
• Last Update Posted: 2018-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcineurin	Calcineurin inhibitors maintenance	Calcineurin inhibitors maintenance
Everolimus	Everolimus	everolimus based immunosuppression

Primary Outcome Measures

Name	Time	Method
Total native kidney volume variation	24 months after randomization	measurements of total native kidney volume with a MRI

Secondary Outcome Measures

Name	Time	Method
Volume variation of the biggest liver cyst	24 months after randomization	Measurements of the biggest liver cyst volume with a MRI
systolic and diastolic blood pressure	At baseline, 1 month, 6 months, 12 months, 18 and 24 months	Clinic measurement
Interstitial Fibrosis/Tubular Atrophy variation	24 months after randomization	IF/TA quantification using Banff criteria during a kidney biopsy
% interstitial fibrosis using Red Sirius staining	24 months after randomization	% fibrosis quantified using a morphometry software
Calculated Estimated Glomerular Filtration rate	At baseline, 1 month, 6 months, 12 months, 18 and 24 months	calculated estimated GFR
Measured Glomerular Filtration rate	At baseline and 24 months	measured GFR
Proteinuria	At baseline, 1 month, 6 months, 12 months, 18 and 24 months	Measurement
Occurrence of diabetes or hyperlipidemia	up to 24 months	Measurements
Occurrence of neoplasia	up to 24 months	Medical chart reporting
Development of HLA Donor Specific Antibody (DSA)	At baseline, 1 month, 6 months, 12 months, 18 and 24 months	V0, 1 year and 2 years after randomization

Trial Locations

Locations (1)

Bicêtre Hospital; 🇫🇷 Le Kremlin-Bicêtre, France