Statin Therapy in Patients With Early Stage ADPKD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2025-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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ADPKD Autosomal Dominant Polycystic Kidney

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo-controlled, parallel study design.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Participants will receive inactive 40 mg tablets of placebo everyday for 6 weeks. If well tolerated, participants will continue taking inactive 40 mg dose of placebo everyday for 2 years.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inactive tablet

Pravastatin

Participants will receive 40 mg tablets of pravastatin everyday for 6 weeks. If well tolerated, participants will continue taking 40 mg dose of pravastatin everyday for 2 years.

Group Type ACTIVE_COMPARATOR

Pravastatin

Intervention Type DRUG

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

Interventions

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Pravastatin

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

Intervention Type DRUG

Placebo

Inactive tablet

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No