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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02134899

Acronym

EVERKYSTE

Enrollment

Registered

2014-05-09

Start date

2014-10-14

Completion date

2017-11-11

Last updated

2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGEverolimus

Change from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression

DRUGCalcineurin inhibitors maintenance

Usual treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Total native kidney volume variation	24 months after randomization	measurements of total native kidney volume with a MRI

Secondary

Measure	Time frame	Description
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
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
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
Proteinuria	At baseline, 1 month, 6 months, 12 months, 18 and 24 months	Measurement

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026