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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Change from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression
Usual treatment
Bicêtre Hospital
Le Kremlin-Bicêtre, France
Total native kidney volume variation
measurements of total native kidney volume with a MRI
Time frame: 24 months after randomization
Volume variation of the biggest liver cyst
Measurements of the biggest liver cyst volume with a MRI
Time frame: 24 months after randomization
Interstitial Fibrosis/Tubular Atrophy variation
IF/TA quantification using Banff criteria during a kidney biopsy
Time frame: 24 months after randomization
% interstitial fibrosis using Red Sirius staining
% fibrosis quantified using a morphometry software
Time frame: 24 months after randomization
Calculated Estimated Glomerular Filtration rate
calculated estimated GFR
Time frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
Measured Glomerular Filtration rate
measured GFR
Time frame: At baseline and 24 months
Proteinuria
Measurement
Time frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
systolic and diastolic blood pressure
Clinic measurement
Time frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Occurrence of diabetes or hyperlipidemia
Measurements
Time frame: up to 24 months
Occurrence of neoplasia
Medical chart reporting
Time frame: up to 24 months
Development of HLA Donor Specific Antibody (DSA)
V0, 1 year and 2 years after randomization
Time frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months