Everolimus on CKD Progression in ADPKD Patients - Full Text View

Sponsor:	A. Manzoni Hospital
Information provided by (Responsible Party):	Prof. Francesco Locatelli, A. Manzoni Hospital
ClinicalTrials.gov Identifier:	NCT01009957

Purpose

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

Condition	Intervention	Phase
Polycystic Kidney Diseases	Drug: Everolimus Drug: Standard Therapy	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Everolimus on CKD Progression in ADPKD Patients

Resource links provided by NLM:

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by A. Manzoni Hospital:

Primary Outcome Measures:

Reduction of GFR (according to MDRD formula) during a two-year follow up [ Time Frame: Two year-followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up [ Time Frame: Two year-followup ] [ Designated as safety issue: No ]
changes in kidney size and renal and liver cysts dimensions evaluated by NMR at basal and at the end of the study [ Time Frame: Two year-followup ] [ Designated as safety issue: No ]
safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events [ Time Frame: Two year-followup ] [ Designated as safety issue: Yes ]
evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point [ Time Frame: Two year-followup ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Everolimus Everolimus + standard therapy for CKD	Drug: Everolimus 0.75 mg x 2 / day Other Name: mTOR inhibitors
No Intervention: Standard therapy for CKD Standard therapy for CKD	Drug: Standard Therapy Standard therapy for CKD Other Name: Conventional therapy for CKD

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009957

Contacts

Contact: Simeone Andrulli, MD

+390341489847

s.andrulli@ospedale.lecco.it

Locations

Italy
A.O. Spedali Civili Di Brescia	Recruiting
Brescia, Italy
Contact: Giovanni Cancarini, Prof. +39 030 3995621 cancarini@med.unibs.it
Sub-Investigator: Battista Fabio Viola, Dr.
Sub-Investigator: Orsola Carli, Dr.
Alessandro Manzoni Hospital, Nephrology and Dialysis Department	Recruiting
Lecco, Italy, 23900
Contact: Simeone Andrulli, MD +390341489847 s.andrulli@ospedale.lecco.it
Principal Investigator: Francesco Locatelli, MD
Sub-Investigator: Donatella Casartelli, md
Sub-Investigator: Andrea Cavalli, MD
Modena Hospital	Recruiting
Modena, Italy, 41100
Contact: Riccardo Magistroni, Dr. 0039 059 4224136 rmagistroni@unimore.it
Sub-Investigator: Riccardo Magistroni, Dr.
Dipartimento di Patologia Sistematica - Università Federico 2°	Recruiting
Napoli, Italy, 80138
Contact: Massimo Sabbatini, MD +390817462614 sabbatin@unina.it
Sub-Investigator: Massimo Sabbatini, MD
Ospedale "Guglielmo da Saliceto" - Nephrology and Dialysis Department	Recruiting
Piacenza, Italy, 29100
Contact: Roberto Scarpioni, MD +39 0523 302331 rscarpioni@hotmail.com
C.M.I.D. - Presidi Ospedalieri ASL 4	Recruiting
Torino, Italy, 10152
Contact: Dario Roccatello, MD +390112403524 dario.roccatello@unito.it
Sub-Investigator: Dario Roccatello, MD
Ospedale Civile San Bortolo Vicenza	Recruiting
Vicenza, Italy
Contact: Fiorella Gastaldon, Dr. 039 0444 753650 fiorella.gastaldon@ulssvicenza.it
Sub-Investigator: Fiorella Gastaldon, Dr.
Sub-Investigator: Claudio Ronco, Prof.

Sponsors and Collaborators

A. Manzoni Hospital

Investigators

Study Chair:

Francesco Locatelli, MD

Nephrology and Dialysis Department - A. Manzoni Hospital

More Information

No publications provided

Responsible Party:	Prof. Francesco Locatelli, A. Manzoni Hospital
ClinicalTrials.gov Identifier:	NCT01009957 History of Changes
Other Study ID Numbers:	PolEver
Study First Received:	November 6, 2009
Last Updated:	April 19, 2012
Health Authority:	Italy: Ethics Committee

Keywords provided by A. Manzoni Hospital:

ADPKD
CKD
Renal disease progression
Everolimus

Additional relevant MeSH terms:

Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors

Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2012