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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Total Kidney Volume

Secondary outcome measures

Change in Circulating Inflammatory Markers

Change in Circulating Markers of Oxidative Stress

Change in Kidney Function

+2 more

Other outcome measures

Change in Blood Vessel Stiffness

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,734 Previous Clinical Trials

2,148,733 Total Patients Enrolled

Michel Chonchol, MDPrincipal InvestigatorUniversity of Colorado, Denver

3 Previous Clinical Trials

258 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT03273413 — Phase 4

Polycystic Kidney Disease Research Study Groups: Placebo, Pravastatin

Polycystic Kidney Disease Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT03273413 — Phase 4

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT03273413 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals below 45 years old considered eligible participants in this research endeavor?

"This trial only accepts patients between the minimum age of 25 and maximum age of 60, as per its specified criteria."

Answered by AI

To what extent is enrollment being opened for this experiment?

"Affirmative, according to the information on clinicaltrials.gov this medical trial is still recruiting participants. The original date of posting was August 31st 2017 and it was most recently updated on January 6th 2022; 200 patients are needed across a single site."

Answered by AI

To what degree does Pravastatin put individuals at risk?

"There is ample evidence that pravastatin is a safe form of treatment, thus it was given a rating of 3 on our scale."

Answered by AI

What maladies is Pravastatin employed to address?

"Pravastatin is utilized in secondary preventative care and to manage cardiovascular diseases, low-density lipoproteins, and coronary heart disease."

Answered by AI

Who would meet the criteria for inclusion in this clinical trial?

"Requirements for this medical study include being between 25 and 60 years old, having polycystic kidney disease, and 200 people can join the trial."

Answered by AI

Could you elaborate on any past trials that have investigated the effects of Pravastatin?

"Currently, there are 9 studies in progress for Pravastatin with 2 of them now reaching the third phase. These trials are mainly situated in Los Angeles, though 64 medical centres across the United States have been enlisted to run these experiments."

Answered by AI

Does this experiment currently accept new participants?

"This research project is presently recruiting participants, as indicated on clinicaltrials.gov; it was initially posted on August 31st 2017 and the latest update occurred on January 6th 2022."

Answered by AI

Recent research and studies

Clinical Journal of the American Society of NephrologyJournal

Effect of Pravastatin on Total Kidney Volume, Left Ventricular Mass Index, and Microalbuminuria in Pediatric Autosomal Dominant Polycystic Kidney Disease

Cadnapaphornchai, Melissa A., Diana M. George, Kim McFann, Wei Wang, Berenice Gitomer, John D. Strain, and Robert W. Schrier. 2014. “Effect of Pravastatin on Total Kidney Volume, Left Ventricular Mass Index, and Microalbuminuria in Pediatric Autosomal Dominant Polycystic Kidney Disease”. Clinical Journal of the American Society of Nephrology. American Society of Nephrology (ASN). doi:10.2215/cjn.08350813.

clinicaltrials.govStudy

Statin Therapy in Patients With Early Stage ADPKD

2017. "Statin Therapy in Patients With Early Stage ADPKD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03273413.

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