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HMG-CoA Reductase Inhibitor
Pravastatin + Alkali Therapy for Polycystic Kidney Disease (ADPKD-SAT Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment for ADPKD patients and will last one year.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include muscle issues related to Pravastatin and digestive changes due to sodium citrate. Patients may also experience changes in blood chemistry or other organ-related symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in blood pressure in patients enrolled in different arms of the study
Changes in kidney function in patients enrolled in different arms of the study
Changes in liver function in patients enrolled in different arms of the study
+2 moreSecondary study objectives
AMPK pathway activation
Inflammatory markers in blood and urine
Urinary alkalinization changes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: ARM I: Control groupActive Control1 Intervention
Standard therapy alone
Group II: ARM II: PRAVASTATINActive Control1 Intervention
Standard therapy and PRAVASTATIN 40 mg QD
Group III: ARM III: PRAV + Sodium CitrateActive Control2 Interventions
Standard therapy and PRAVASTATIN 40 mg QD and Sodium Citrate (up to 30 mL TID)
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,615 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.You have a condition called metabolic acidosis.Your blood has a low level of bicarbonate.You have a recent heart condition, liver or muscle disease, or a past problem with fluid in your lungs.You have a condition that affects your kidneys, as determined by the doctor.You have high blood pressure that is not well controlled, swelling, or a serious heart condition according to the doctor's decision.Your kidney function, measured by GFR, is above a certain level.You have a history of kidney stones.Your Creatine Phospho Kinase (CPK) levels are higher than the normal range.You have a cerebral aneurysm that is not stable, as determined by the doctor.You have been diagnosed with ADPKD using a combination of ultrasound, genetic testing, and MRI if necessary.These ultrasound criteria are used to diagnose ADPKD in people from families with the disease, but where the specific genetic cause is not known.
Research Study Groups:
This trial has the following groups:- Group 1: ARM I: Control group
- Group 2: ARM II: PRAVASTATIN
- Group 3: ARM III: PRAV + Sodium Citrate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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