Everolimus on CKD Progression in ADPKD Patients

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: A. Manzoni Hospital
• Treatments: Everolimus; Sirolimus

Criteria

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