Statin Therapy in Patients with Early Stage ADPKD

Colorado

Overview

This study plans to learn if pravastatin is helpful in slowing down the progression of kidney disease in adults with 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 using

  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
  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.

Intervention:

Drug: Pravastatin

Drug: Placebo

Inclusion criteria:

  • Males and females 25-60 years of age
  • Diagnosis of ADPKD
  • EGFR ≥45 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 breastfeeding
  • Current tobacco use
  • Alcohol abuse or dependence

Contact Information:

Diana George
303-724-1684
diana.george@ucdenver.edu

Nina Bispham, MS
303-724-1692
nina.bispham@ucdenver.edu