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Statin Therapy for Polycystic Kidney Disease

Phase 4

Waitlist Available

Led By Michel Chonchol, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of ADPKD

Total kidney volume >500 mL

Must not have

History of hospitalizations within the last 3 months

Secondary hypercholesterolemia or hypocholesterolemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 years

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will test whether pravastatin can help slow the progression of kidney disease in adults with autosomal dominant polycystic kidney disease.

Who is the study for?

This trial is for adults with early stage autosomal dominant polycystic kidney disease (ADPKD). Participants should have a kidney volume over 500 mL, good kidney function (GFR ≥60), and controlled blood pressure. It's not for those recently hospitalized, pregnant or breastfeeding women, tobacco users, people with alcohol issues, uncontrolled high blood pressure, diabetes, certain cholesterol disorders or sensitivities to statins.

What is being tested?

The study is testing if pravastatin can slow down the progression of ADPKD compared to a placebo. Pravastatin is usually used for high cholesterol but here it's being investigated specifically for ADPKD. Patients will be randomly assigned to either receive pravastatin or a placebo.

What are the potential side effects?

Pravastatin may cause muscle pain or weakness, headache, nausea, vomiting; rare side effects include liver problems and severe muscle breakdown leading to kidney damage. The placebo group might experience no actual drug side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with polycystic kidney disease.

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My kidneys are larger than normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been hospitalized in the last 3 months.

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I have abnormal cholesterol levels not due to my diet.

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I am currently taking tolvaptan, gemfibrozil, niacin, clarithromycin, or cyclosporine.

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I have not taken immunosuppressive drugs in the last year.

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I have kidney issues, including recent surgery or injury.

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I have been diagnosed with coronary artery disease.

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My high blood pressure is not under control.

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I have had a stroke caused by a blood clot before.

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I have unstable chest pain.

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I have liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Total Kidney Volume

Secondary study objectives

Change in Circulating Inflammatory Markers

Change in Circulating Markers of Oxidative Stress

Change in Kidney Function

+2 more

Other study objectives

Change in Blood Vessel Stiffness

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: PravastatinActive Control1 Intervention

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 II: PlaceboPlacebo Group1 Intervention

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.

0 / 12Eligibility criteria met