Everolimus on CKD Progression in ADPKD Patients
This study is currently recruiting participants.
Verified April 2012 by A. Manzoni Hospital
Sponsor:
A. Manzoni Hospital
Information provided by (Responsible Party):
Prof. Francesco Locatelli, A. Manzoni Hospital
ClinicalTrials.gov Identifier:
NCT01009957
First received: November 6, 2009
Last updated: April 19, 2012
Last verified: April 2012
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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:
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, Cystic Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urologic Diseases 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 June 17, 2013