Everolimus on CKD Progression in ADPKD Patients

A. Manzoni Hospital

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Polycystic Kidney Diseases

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT01009957

PolEver

Details and patient eligibility

About

The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients.

Full description

Considering the inhibitor activity of Everolimus on mTOR, our hypothesis is to evaluate its possible utility on the progression of CKD in ADPKD patients by reducing the rate of increase of renal cysts.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects over 18 years of both genders
2. Clinical diagnosis of autosomal dominant polycystic kidney disease (ADPKD)
3. GFR, according to MDRD formula, between 30 and 90 ml/min/1.73 mq
4. Previous follow up of two years, with a creatinine evaluation at least once a year
5. GFR reduction of at least 2.5 ml/min/year (according to MDRD formula)

Exclusion criteria

1. Pregnancy, lactating, males and females without adequate contraception
2. Leucopenia (< 3,000 leucocytes/mm3) or thrombocytopenia (< 100,000 platelets/mm3)
3. Dyslipidemia (cholesterol or triglycerides > 260 mg/dl with treatment)
4. Urinary tract infection
5. Patients who cannot undergoing NMR

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Everolimus

Experimental group

Description:

Everolimus + standard therapy for CKD

Treatment:

Drug: Everolimus

Control

No Intervention group

Description:

Standard therapy for CKD