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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

Study Interventions

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

Study Arms

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

Study Status

Terminated

Start Date: June 2008

Completed Date: June 2015

Phase: Phase 2/Phase 3

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01009957

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