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

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134899
• Other study ID #: P 090804
• Secondary ID: 2012-004265-41
• Status: Completed
• Phase: Phase 3
• Start date: October 14, 2014
• Est. completion date: November 11, 2017

Study information

• Verified date: December 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: November 11, 2017
• Est. primary completion date: November 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Drug:
• Everolimus
Change from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression
• Calcineurin inhibitors maintenance
Usual treatment

Locations

Country	Name	City	State
France	Bicêtre Hospital	Le Kremlin-Bicêtre

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Novartis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total native kidney volume variation	measurements of total native kidney volume with a MRI	24 months after randomization
Secondary	Volume variation of the biggest liver cyst	Measurements of the biggest liver cyst volume with a MRI	24 months after randomization
Secondary	Interstitial Fibrosis/Tubular Atrophy variation	IF/TA quantification using Banff criteria during a kidney biopsy	24 months after randomization
Secondary	% interstitial fibrosis using Red Sirius staining	% fibrosis quantified using a morphometry software	24 months after randomization
Secondary	Calculated Estimated Glomerular Filtration rate	calculated estimated GFR	At baseline, 1 month, 6 months, 12 months, 18 and 24 months
Secondary	Measured Glomerular Filtration rate	measured GFR	At baseline and 24 months
Secondary	Proteinuria	Measurement	At baseline, 1 month, 6 months, 12 months, 18 and 24 months
Secondary	systolic and diastolic blood pressure	Clinic measurement	At baseline, 1 month, 6 months, 12 months, 18 and 24 months
Secondary	Occurrence of diabetes or hyperlipidemia	Measurements	up to 24 months
Secondary	Occurrence of neoplasia	Medical chart reporting	up to 24 months
Secondary	Development of HLA Donor Specific Antibody (DSA)	V0, 1 year and 2 years after randomization	At baseline, 1 month, 6 months, 12 months, 18 and 24 months