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NCT Number: NCT03273413

Statin Therapy in Patients With Early Stage ADPKD

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

ADPKD Abnormalities, Multiple Autosomal Dominant Polycystic Kidney Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Denver Anschutz Medical Campus

Denver, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pravastatin

Drug

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

Placebo

Drug

Inactive tablet

Primary outcomes

  1. Change in Total Kidney Volume

    Time frame: Baseline, 2 years

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

Secondary outcomes

  1. Change in Renal Blood Flow

    Time frame: Baseline, 2 years

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

  2. Change in Kidney Function

    Time frame: Baseline, 2 years

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

  3. Change in Circulating Inflammatory Markers

    Time frame: Baseline, 2 years

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

  4. Change in Circulating Markers of Oxidative Stress

    Time frame: Baseline, 2 years

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

  5. Change in Urinary Epithelial Cells

    Time frame: Baseline, 2 years

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

Other outcomes

  1. Change in Blood Vessel Stiffness

    Time frame: Baseline, 2 years

    Blood vessel stiffness, as assessed by carotid-femoral pulse wave velocity, at baseline and after 2 years

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2017
Primary completion
2024
Study completion
2025
First posted
Sep 6, 2017
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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