The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients
- Conditions
- Autosomal Dominant Polycystic Kidney Disease
- Interventions
- Drug: Calcineurin inhibitors maintenance
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
- 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
- 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
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
systolic and diastolic blood pressure At baseline, 1 month, 6 months, 12 months, 18 and 24 months Clinic 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