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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

ADPKD-SAT Trial 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.Check my eligibility
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.See study design
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.

ADPKD-SAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
AMPK pathway activation
Inflammatory markers in blood and urine
Urinary alkalinization changes

ADPKD-SAT 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
905 Previous Clinical Trials
1,596,248 Total Patients Enrolled

Media Library

Pravastatin (HMG-CoA Reductase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04284657 — Phase 2
Polycystic Kidney Disease Research Study Groups: ARM I: Control group, ARM II: PRAVASTATIN, ARM III: PRAV + Sodium Citrate
Polycystic Kidney Disease Clinical Trial 2023: Pravastatin Highlights & Side Effects. Trial Name: NCT04284657 — Phase 2
Pravastatin (HMG-CoA Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04284657 — Phase 2

Frequently Asked Questions

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

How many participants are being recruited for this investigation?

"This investigation is no longer looking for participants. It first appeared on the 30th of January 2019 and its latest update was posted on the 24th of January 2022. If you are still searching for a suitable trial, there are currently 488 studies actively admitting patients with kidney diseases as well as 12 trials specifically related to ARM II: Pravastatin that require enrollees."

Answered by AI

Have there been additional investigations involving ARM II: PRAVASTATIN?

"Currently, there are 12 studies in progress that evaluate the efficacy of ARM II: PRAVASTATIN with 3 trials currently undergoing Phase 3. Most sites are located within Los Angeles but 67 total clinical trial locations are engaging participants for this research."

Answered by AI

Is ARM II: PRAVASTATIN generally well-tolerated by most individuals?

"Considering the information available, our team at Power estimates that ARM II: PRAVASTATIN is a safe treatment option with a score of 2 on this scale. This assessment was based off the Phase 2 trial's data which supports safety but not efficacy."

Answered by AI

Are there still vacancies for participants in this clinical experiment?

"According to clinicaltrials.gov, this study is not presently accepting participants. The trial was initially announced on January 30th 2019 and its last update was posted on January 24th 2022. However, there are 500 other clinical trials actively recruiting right now."

Answered by AI

What condition or disorder is ARM II: PRAVASTATIN primarily applied to?

"ARM II: PRAVASTATIN is typically employed to facilitate irrigation during surgeries, with additional applications in the management of cardiovascular disease (cvd), plasmapheresis, and catarrh."

Answered by AI
~5 spots leftby Apr 2025