Polycystic Kidney Diseases | Everolimus on CKD Progression in ADPKD Patients
Polycystic Kidney Diseases research study
What is the primary objective of this study?
The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Polycystic Kidney Diseases
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Everolimus0.75 mg x 2 / day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
EverolimusEverolimus + standard therapy for CKD
ControlStandard therapy for CKD
Start Date: June 2008
Completed Date: June 2015
Phase: Phase 2/Phase 3
Primary Outcome: Reduction of GFR (according to MDRD formula) during a two-year follow up
Secondary Outcome: reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up
Study sponsors, principal investigator, and references
Principal Investigator: Francesco Locatelli, MD
Lead Sponsor: A. Manzoni Hospital