Everolimus on CKD Progression in ADPKD Patients

Polycystic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01009957
• Other study ID #: PolEver
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: November 6, 2009
• Last updated: June 22, 2015
• Start date: June 2008
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: A. Manzoni Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: June 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Polycystic Kidney Diseases

Intervention

Drug:
• Everolimus
0.75 mg x 2 / day

Locations

Country	Name	City	State
Italy	A.O. Spedali Civili Di Brescia	Brescia
Italy	Alessandro Manzoni Hospital, Nephrology and Dialysis Department	Lecco
Italy	Modena Hospital	Modena
Italy	Dipartimento di Patologia Sistematica - Università Federico 2°	Napoli
Italy	Ospedale "Guglielmo da Saliceto" - Nephrology and Dialysis Department	Piacenza
Italy	C.M.I.D. - Presidi Ospedalieri ASL 4	Torino
Italy	Ospedale Civile San Bortolo Vicenza	Vicenza

Sponsors (1)

Lead Sponsor	Collaborator
A. Manzoni Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of GFR (according to MDRD formula) during a two-year follow up		Two year-followup	No
Secondary	reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up		Two year-followup	No
Secondary	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	No
Secondary	safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events		Two year-followup	Yes
Secondary	evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point		Two year-followup	No