Clinical trial NCT03273413: Statin Therapy in Patients With Early Stage ADPKD
Official title: Statin Therapy in Patients With Early Stage ADPKD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: ADPKD
Autosomal Dominant Polycystic Kidney
Keywords: Pravastatin
Statin
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, parallel study design.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Total Kidney Volume
timeFrame: Baseline, 2 years
Secondary outcomes:
measure: Change in Renal Blood Flow
timeFrame: Baseline, 2 years
measure: Change in Kidney Function
timeFrame: Baseline, 2 years
measure: Change in Circulating Inflammatory Markers
timeFrame: Baseline, 2 years
measure: Change in Circulating Markers of Oxidative Stress
timeFrame: Baseline, 2 years
measure: Change in Urinary Epithelial Cells
timeFrame: Baseline, 2 years
Other outcomes:
measure: Change in Blood Vessel Stiffness
timeFrame: Baseline, 2 years
Locations:
city: Denver
country: United States
facility: University of Colorado Denver Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Michel Chonchol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cadnapaphornchai MA, George DM, McFann K, Wang W, Gitomer B, Strain JD, Schrier RW. Effect of pravastatin on total kidney volume, left ventricular mass index, and microalbuminuria in pediatric autosomal dominant polycystic kidney disease. Clin J Am Soc Nephrol. 2014 May;9(5):889-96. doi: 10.2215/CJN.08350813. Epub 2014 Apr 10.