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

Primary Purpose

Autosomal Dominant Polycystic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Everolimus
Calcineurin inhibitors maintenance
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease focused on measuring Autosomal dominant polycystic kidney disease, cyst, kidney, liver, kidney transplantation, IF/TA, fibrosis, DSA, mTOR inhibitors, calcineurin inhibitors

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bicêtre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Everolimus

Calcineurin

Arm Description

everolimus based immunosuppression

Calcineurin inhibitors maintenance

Outcomes

Primary Outcome Measures

Total native kidney volume variation
measurements of total native kidney volume with a MRI

Secondary Outcome Measures

Volume variation of the biggest liver cyst
Measurements of the biggest liver cyst volume with a MRI
Interstitial Fibrosis/Tubular Atrophy variation
IF/TA quantification using Banff criteria during a kidney biopsy
% interstitial fibrosis using Red Sirius staining
% fibrosis quantified using a morphometry software
Calculated Estimated Glomerular Filtration rate
calculated estimated GFR
Measured Glomerular Filtration rate
measured GFR
Proteinuria
Measurement
systolic and diastolic blood pressure
Clinic measurement
Occurrence of diabetes or hyperlipidemia
Measurements
Occurrence of neoplasia
Medical chart reporting
Development of HLA Donor Specific Antibody (DSA)
V0, 1 year and 2 years after randomization

Full Information

First Posted
April 28, 2014
Last Updated
December 7, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT02134899
Brief Title
The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients
Acronym
EVERKYSTE
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 14, 2014 (Actual)
Primary Completion Date
November 11, 2017 (Actual)
Study Completion Date
November 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney Disease
Keywords
Autosomal dominant polycystic kidney disease, cyst, kidney, liver, kidney transplantation, IF/TA, fibrosis, DSA, mTOR inhibitors, calcineurin inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Everolimus
Arm Type
Experimental
Arm Description
everolimus based immunosuppression
Arm Title
Calcineurin
Arm Type
Active Comparator
Arm Description
Calcineurin inhibitors maintenance
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
everolimus conversion
Intervention Description
Change from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression
Intervention Type
Drug
Intervention Name(s)
Calcineurin inhibitors maintenance
Other Intervention Name(s)
calcineurin-inhibitors based immunosuppression
Intervention Description
Usual treatment
Primary Outcome Measure Information:
Title
Total native kidney volume variation
Description
measurements of total native kidney volume with a MRI
Time Frame
24 months after randomization
Secondary Outcome Measure Information:
Title
Volume variation of the biggest liver cyst
Description
Measurements of the biggest liver cyst volume with a MRI
Time Frame
24 months after randomization
Title
Interstitial Fibrosis/Tubular Atrophy variation
Description
IF/TA quantification using Banff criteria during a kidney biopsy
Time Frame
24 months after randomization
Title
% interstitial fibrosis using Red Sirius staining
Description
% fibrosis quantified using a morphometry software
Time Frame
24 months after randomization
Title
Calculated Estimated Glomerular Filtration rate
Description
calculated estimated GFR
Time Frame
At baseline, 1 month, 6 months, 12 months, 18 and 24 months
Title
Measured Glomerular Filtration rate
Description
measured GFR
Time Frame
At baseline and 24 months
Title
Proteinuria
Description
Measurement
Time Frame
At baseline, 1 month, 6 months, 12 months, 18 and 24 months
Title
systolic and diastolic blood pressure
Description
Clinic measurement
Time Frame
At baseline, 1 month, 6 months, 12 months, 18 and 24 months
Title
Occurrence of diabetes or hyperlipidemia
Description
Measurements
Time Frame
up to 24 months
Title
Occurrence of neoplasia
Description
Medical chart reporting
Time Frame
up to 24 months
Title
Development of HLA Donor Specific Antibody (DSA)
Description
V0, 1 year and 2 years after randomization
Time Frame
At baseline, 1 month, 6 months, 12 months, 18 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène François, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bicêtre Hospital
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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