|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
3 August 2015 |
|
Main ID: |
NCT01009957 |
|
Date of registration:
|
06/11/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Everolimus on CKD Progression in ADPKD Patients
|
|
Scientific title:
|
Everolimus on CKD (Chronic Kidney Disease) Progression in ADPKD Patients |
|
Date of first enrolment:
|
June 2008 |
|
Target sample size:
|
71 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT01009957 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 2/Phase 3
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Francesco Locatelli, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Nephrology and Dialysis Department - A. Manzoni Hospital |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Polycystic Kidney Diseases
|
|
Intervention(s)
|
|
Drug: Everolimus
|
|
Primary Outcome(s)
|
|
Reduction of GFR (according to MDRD formula) during a two-year follow up
[Time Frame: Two year-followup]
|
|
Secondary Outcome(s)
|
|
evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point
[Time Frame: 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
[Time Frame: Two year-followup]
|
|
safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events
[Time Frame: Two year-followup]
|
|
reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up
[Time Frame: Two year-followup]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|