Statin Therapy in Patients With Early Stage ADPKD

Phase 4Active Not RecruitingNCT03273413

University of Colorado, Denver150 enrolled

Overview

This study plans to learn if pravastatin is helpful in slowing down the progression of kidney disease in adults with autosomal dominant polycystic kidney disease (ADPKD). Pravastatin has been approved by the Food and Drug Administration (FDA) for adults for treatment of hyperlipidemia (high cholesterol levels). The investigators are using pravastatin in this study as an investigational drug for treatment of ADPKD.

This is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and benefits of pravastatin therapy in adults with ADPKD by evaluating 1) kidney volume as measured by kidney magnetic resonance imaging (MRI); 2) renal blood flow as measured by kidney magnetic resonance angiography (MRA); 3) kidney function as assessed by Glofil-125; 4) plasma and urine protein markers that will allow a better understanding of how pravastatin works in ADPKD; and 5) blood vessel stiffness as measured by carotid-femoral pulse wave velocity. These parameters will be measured at baseline and after 2 years of pravastatin or placebo treatment in 150 patients with ADPKD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

ADPKD Autosomal Dominant Polycystic Kidney

Interventions

PravastatinDRUG

Anti-inflammatory, anti-oxidative stress, and anti-proliferative therapy

PlaceboDRUG

Inactive tablet

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of ADPKD * Total kidney volume \>500 mL * Estimated glomerular filtration rate (GFR) ≥60 mL/min/1.73m\^2 * Controlled blood pressure \<140/80 mmHg Exclusion Criteria: * Uncontrolled hypertension * Diabetes mellitus * Renal disease, renal cancer, single kidney, recent renal surgery, or acute kidney injury * Unstable angina * Coronary artery disease * Prior ischemic stroke * Other clinical indication for a statin * History of hospitalizations within the last 3 months * Hepatic impairment or liver function abnormalities * Secondary hypercholesterolemia or hypocholesterolemia * Use of tolvaptan, gemfibrozil, other fibrates, niacin, clarithromycin, or cyclosporine * Hypersensitivity to statins * Immunosuppressive therapy within the last year * Clinical contraindication for an MRI (i.e. implants, pacemaker, claustrophobia) * Hypersensitivity to iodine * Pregnant or breast feeding * Current tobacco use * Alcohol abuse or dependence

Locations (1)

University of Colorado Denver Anschutz Medical Campus

Denver, Colorado, United States

Outcomes

Primary Outcomes

Change in Total Kidney Volume

Total kidney volume as assessed by renal MRI, at baseline and after 2 years of treatment

Time frame: Baseline, 2 years

Secondary Outcomes

Change in Renal Blood Flow

Renal blood flow, as assessed by renal MRA, at baseline and after 2 years of treatment

Time frame: Baseline, 2 years

Change in Kidney Function

Glomerular filtration rate (GFR), as assessed by Glofil-125, at baseline and after 2 years of treatment

Time frame: Baseline, 2 years

Change in Circulating Inflammatory Markers

Plasma levels of inflammatory cytokines and growth factors at baseline and after 2 years of treatment

Time frame: Baseline, 2 years

Change in Circulating Markers of Oxidative Stress

Plasma levels of oxidative stress markers at baseline and after 2 years of treatment

Time frame: Baseline, 2 years

Change in Urinary Epithelial Cells

Urinary epithelial cell protein expression, as assessed by immunofluorescence, at baseline and after 2 years of treatment

Time frame: Baseline, 2 years

Data from ClinicalTrials.gov

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