search
Back to results

Everolimus on CKD Progression in ADPKD Patients

Primary Purpose

Polycystic Kidney Diseases

Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Everolimus
Sponsored by
A. Manzoni Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Kidney Diseases focused on measuring ADPKD, CKD, Renal disease progression, Everolimus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Everolimus

Control

Arm Description

Everolimus + standard therapy for CKD

Standard therapy for CKD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up
changes in kidney size and renal and liver cysts dimensions evaluated by NMR at basal and at the end of the study
safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events
evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point

Full Information

First Posted
November 6, 2009
Last Updated
June 22, 2015
Sponsor
A. Manzoni Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01009957
Brief Title
Everolimus on CKD Progression in ADPKD Patients
Official Title
Everolimus on CKD (Chronic Kidney Disease) Progression in ADPKD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
After primary completition date, experimental drug was no longer available
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
A. Manzoni Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Kidney Diseases
Keywords
ADPKD, CKD, Renal disease progression, Everolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Everolimus
Arm Type
Experimental
Arm Description
Everolimus + standard therapy for CKD
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard therapy for CKD
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
mTOR inhibitors
Intervention Description
0.75 mg x 2 / day
Primary Outcome Measure Information:
Title
Reduction of GFR (according to MDRD formula) during a two-year follow up
Time Frame
Two year-followup
Secondary Outcome Measure Information:
Title
reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up
Time Frame
Two year-followup
Title
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
Title
safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events
Time Frame
Two year-followup
Title
evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point
Time Frame
Two year-followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Locatelli, MD
Organizational Affiliation
Nephrology and Dialysis Department - A. Manzoni Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
A.O. Spedali Civili Di Brescia
City
Brescia
Country
Italy
Facility Name
Alessandro Manzoni Hospital, Nephrology and Dialysis Department
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Modena Hospital
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Dipartimento di Patologia Sistematica - Università Federico 2°
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Ospedale "Guglielmo da Saliceto" - Nephrology and Dialysis Department
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
C.M.I.D. - Presidi Ospedalieri ASL 4
City
Torino
ZIP/Postal Code
10152
Country
Italy
Facility Name
Ospedale Civile San Bortolo Vicenza
City
Vicenza
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Everolimus on CKD Progression in ADPKD Patients

We'll reach out to this number within 24 hrs