NCT02134899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

October 14, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2017

Completed
Last Updated

December 10, 2018

Status Verified

December 1, 2018

Enrollment Period

3.1 years

First QC Date

April 28, 2014

Last Update Submit

December 7, 2018

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

Autosomal dominant polycystic kidney diseasecystkidneyliverkidney transplantationIF/TAfibrosisDSAmTOR inhibitorscalcineurin inhibitors

Outcome Measures

Primary Outcomes (1)

  • Total native kidney volume variation

    measurements of total native kidney volume with a MRI

    24 months after randomization

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Everolimus

EXPERIMENTAL

everolimus based immunosuppression

Drug: Everolimus

Calcineurin

ACTIVE COMPARATOR

Calcineurin inhibitors maintenance

Drug: Calcineurin inhibitors maintenance

Interventions

EverolimusDRUG

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

Also known as: everolimus conversion
Everolimus
Calcineurin inhibitors maintenanceDRUG

Usual treatment

Also known as: calcineurin-inhibitors based immunosuppression
Calcineurin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • signed informed consent not obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal DominantCystsFibrosis

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Polycystic Kidney DiseasesKidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, InbornNeoplasmsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Hélène François, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 9, 2014

Study Start

October 14, 2014

Primary Completion

November 11, 2017

Study Completion

November 11, 2017

Last Updated

December 10, 2018

Record last verified: 2018-12

Locations

FR(1)