Pravastatin + Alkali Therapy for Polycystic Kidney Disease

(ADPKD-SAT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is an one-year open-label study to determine treatment efficacy and feasibility of a trial that uses open-label interventions in ADPKD patients.

Eligibility Criteria

Adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and moderate kidney function (stage 1-3b CKD), not pregnant or breastfeeding, willing to use effective contraception. Excludes those with significant protein in urine, cancer history, liver disease, certain allergies, uncontrolled blood pressure, edema or severe metabolic acidosis.

Inclusion Criteria

You have a condition called metabolic acidosis.

Your blood has a low level of bicarbonate.

Patient voluntarily gives informed consent to participate in the study and signed study's IC and HIPAA

Exclusion Criteria

You have more than 500 milligrams of protein in your urine every day.

You have had cancer in the past.

You have had serious liver problems like liver failure, cirrhosis, or liver shock.

Participant Groups

The study is testing the effectiveness of Pravastatin and sodium citrate over one year in patients with ADPKD. It's an open-label trial where all participants know which treatments they are receiving.

Group I: ARM I: Control group Active Control 1 Intervention

Standard therapy alone

Group II: ARM II: PRAVASTATIN Active Control 1 Intervention

Standard therapy and PRAVASTATIN 40 mg QD

Group III: ARM III: PRAV + Sodium Citrate Active Control 2 Interventions

Standard therapy and PRAVASTATIN 40 mg QD and Sodium Citrate (up to 30 mL TID)

Pravastatin is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Pravachol for:

• High Cholesterol
• Hyperlipoproteinemia
• Myocardial Infarction - Prophylaxis
• Revascularization Procedures - Prophylaxis

🇪🇺 Approved in European Union as Pravastatin for:

• Hypercholesterolaemia
• Mixed dyslipidaemia
• Prevention of cardiovascular events

🇨🇦 Approved in Canada as Pravastatin for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Prevention of cardiovascular events

🇯🇵 Approved in Japan as Pravastatin for:

• Hypercholesterolemia
• Familial hypercholesterolemia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Keck School of Medicine of University of Southern California Los Angeles, CA

Who Is Running the Clinical Trial?

University of Southern California Lead Sponsor

References