Everolimus on CKD Progression in ADPKD Patients

This study has been terminated.
(After primary completition date, experimental drug was no longer available)
Sponsor:
Information provided by (Responsible Party):
Prof. Francesco Locatelli, A. Manzoni Hospital
ClinicalTrials.gov Identifier:
NCT01009957
First received: November 6, 2009
Last updated: June 22, 2015
Last verified: June 2015
  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
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 (Chronic Kidney Disease) 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 ]

Enrollment: 71
Study Start Date: June 2008
Study Completion Date: June 2015
Primary Completion Date: January 2014 (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: Control
Standard 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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
A.O. Spedali Civili Di Brescia
Brescia, Italy
Alessandro Manzoni Hospital, Nephrology and Dialysis Department
Lecco, Italy, 23900
Modena Hospital
Modena, Italy, 41100
Dipartimento di Patologia Sistematica - Università Federico 2°
Napoli, Italy, 80138
Ospedale "Guglielmo da Saliceto" - Nephrology and Dialysis Department
Piacenza, Italy, 29100
C.M.I.D. - Presidi Ospedalieri ASL 4
Torino, Italy, 10152
Ospedale Civile San Bortolo Vicenza
Vicenza, Italy
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: June 22, 2015
Health Authority: Italy: Ethics Committee

Keywords provided by A. Manzoni Hospital:
ADPKD
CKD
Renal disease progression
Everolimus

Additional relevant MeSH terms:
Kidney Diseases
Multicystic Dysplastic Kidney
Polycystic Kidney Diseases
Congenital Abnormalities
Kidney Diseases, Cystic
Urogenital Abnormalities
Urologic Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015