Clinical trial NCT02134899: The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: Autosomal dominant polycystic kidney disease
cyst
kidney
liver
kidney transplantation
IF/TA
fibrosis
DSA
mTOR inhibitors
calcineurin inhibitors
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2014-05-09
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total native kidney volume variation
timeFrame: 24 months after randomization
Secondary outcomes:
measure: Volume variation of the biggest liver cyst
timeFrame: 24 months after randomization
measure: Interstitial Fibrosis/Tubular Atrophy variation
timeFrame: 24 months after randomization
measure: % interstitial fibrosis using Red Sirius staining
timeFrame: 24 months after randomization
measure: Calculated Estimated Glomerular Filtration rate
timeFrame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
measure: Measured Glomerular Filtration rate
timeFrame: At baseline and 24 months
measure: Proteinuria
timeFrame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
measure: systolic and diastolic blood pressure
timeFrame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
measure: Occurrence of diabetes or hyperlipidemia
timeFrame: up to 24 months
measure: Occurrence of neoplasia
timeFrame: up to 24 months
measure: Development of HLA Donor Specific Antibody (DSA)
timeFrame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Bicêtre Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hélène François, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: