An Open-labelled Multicenter Randomized Study on the Efficacy of Everolimus in Reducing Total Native Kidney Volume in Kidney Transplanted Patients With Autosomal Dominant Polycystic Kidney Disease
Overview
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Total native kidney volume variation
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Everolimus
everolimus based immunosuppression
Intervention: Everolimus (Drug)
Calcineurin
Calcineurin inhibitors maintenance
Intervention: Calcineurin inhibitors maintenance (Drug)
Outcomes
Primary Outcomes
Total native kidney volume variation
Time Frame: 24 months after randomization
measurements of total native kidney volume with a MRI
Secondary Outcomes
- Volume variation of the biggest liver cyst(24 months after randomization)
- Interstitial Fibrosis/Tubular Atrophy variation(24 months after randomization)
- % interstitial fibrosis using Red Sirius staining(24 months after randomization)
- Calculated Estimated Glomerular Filtration rate(At baseline, 1 month, 6 months, 12 months, 18 and 24 months)
- Measured Glomerular Filtration rate(At baseline and 24 months)
- Proteinuria(At baseline, 1 month, 6 months, 12 months, 18 and 24 months)
- systolic and diastolic blood pressure(At baseline, 1 month, 6 months, 12 months, 18 and 24 months)
- Occurrence of diabetes or hyperlipidemia(up to 24 months)
- Occurrence of neoplasia(up to 24 months)
- Development of HLA Donor Specific Antibody (DSA)(At baseline, 1 month, 6 months, 12 months, 18 and 24 months)