NCT02134899

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autosomal Dominant Polycystic Kidney Disease

Interventions

Type	Name	Description
DRUG	Everolimus	Change from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression
DRUG	Calcineurin inhibitors maintenance	Usual treatment

Timeline

• Start date: 2014-10-14
• Primary completion: 2017-11-11
• Completion: 2017-11-11
• First posted: 2014-05-09
• Last updated: 2018-12-10

Locations

1 site across 1 country: France