Everolimus on CKD Progression in ADPKD Patients

Everolimus on CKD (Chronic Kidney Disease) Progression in ADPKD Patients

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01009957

Enrollment

Registered

2009-11-09

Start date

2008-06-30

Completion date

2015-06-30

Last updated

2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Kidney Diseases

Keywords

ADPKD, CKD, Renal disease progression, Everolimus

Brief summary

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

Detailed 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.

Interventions

DRUGEverolimus

0.75 mg x 2 / day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Reduction of GFR (according to MDRD formula) during a two-year follow up	Two year-followup

Secondary

Measure	Time frame
reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up	Two year-followup
changes in kidney size and renal and liver cysts dimensions evaluated by NMR at basal and at the end of the study	Two year-followup
safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events	Two year-followup
evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point	Two year-followup

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026