Everolimus on CKD Progression in ADPKD Patients

NCT01009957 | Terminated Phase 2 DMC

• 1 other identifier: PolEver
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 7

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.

Conditions

Polycystic Kidney Diseases

Keywords

ADPKD; CKD; Renal disease progression; Everolimus

Outcome Measures

Primary Outcomes (1)

• Reduction of GFR (according to MDRD formula) during a two-year follow up

  Two year-followup

Secondary Outcomes (4)

• 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

Study Arms (2)

Everolimus

EXPERIMENTAL

Everolimus + standard therapy for CKD

Drug: Everolimus

Control

NO INTERVENTION

Standard therapy for CKD

Interventions

Everolimus DRUG

0.75 mg x 2 / day

Also known as: mTOR inhibitors

Everolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• A. Manzoni Hospital: lead

Study Sites (7)

A.O. Spedali Civili Di Brescia

Brescia, Italy

Location

Alessandro Manzoni Hospital, Nephrology and Dialysis Department

Lecco, 23900, Italy

Location

Modena Hospital

Modena, 41100, Italy

Location

Dipartimento di Patologia Sistematica - Università Federico 2°

Napoli, 80138, Italy

Location

Ospedale "Guglielmo da Saliceto" - Nephrology and Dialysis Department

Piacenza, 29100, Italy

Location

C.M.I.D. - Presidi Ospedalieri ASL 4

Torino, 10152, Italy

Location

Ospedale Civile San Bortolo Vicenza

Vicenza, Italy

Location

MeSH Terms

Conditions

Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant

Interventions

Everolimus; MTOR Inhibitors

Condition Hierarchy (Ancestors)

Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Francesco Locatelli, MD

  Nephrology and Dialysis Department - A. Manzoni Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Francesco Locatelli

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 9, 2009
• Study Start: June 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2015
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

IT (7)