AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Bempedoic Acid Therapy for Polycystic Kidney Disease

RecruitingPhase 2Ages 18 Years - 60 YearsAllKenneth Hallows
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

Autosomal dominant polycystic kidney disease (ADPKD), the most commonly inherited kidney disease, is characterized by the development of cysts in the kidney that impair function. Of those affected, half will progress to end-stage kidney disease by age 60, requiring dialysis or kidney transplant. To date, no effective and safe therapies exist for this deadly disease. Tolvaptan (Tol), the only FDA-approved drug for treatment of ADPKD, has some benefit in slowing kidney disease progression, but Tol causes frequent urination and thirst and also injures the liver in a small number of patients. The investigators' goal, therefore, is to develop new strategies to treat ADPKD that are safe and tolerable. The development of cysts in ADPKD patients results from two main cellular processes. The first is cell growth with an increase in the number of kidney cells that make up the outer surface of the

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * ADPKD patients as defined by Pei-Ravine criteria * Age 18-60 years * Mayo Imaging Classifications (MIC) 1C-1E or MIC 1B with defined eGFR decline \>3 ml/min/1.73m2/yr (estimated from serum creatinine using the CKD-Epi equation) * Estimated glomerular filtration rate (eGFR) โ‰ฅ35 ml/min/1.73m2 by CKD-Epi equation utilizing creatinine * Fluent English-speaking * Able to provide informed consent * Patients with and without current tolvaptan use (prescribed by primary nephrologist) at a stable dose for โ‰ฅ3 months Exclusion Criteria: * Estimated GFR\<35 ml/min/1.73m2 (estimated from serum creatinine using the CKD-Epi equation) * Proteinuria \>500 mg/day * Current bempedoic acid (BA) use or history of hypersensitivity to BA * Diabetes (currently diagnosed, or fasting glucose \>125 mg/dL) * Serum uric acid \>10 mg/dL or 1 or more acute gout flare within the prior year * Known active hepatitis or abnormal baseline liver function tests (LFTs) which is defined for patients who are not taking concomitant tolvaptan as ALT, AST or direct bilirubin \>1.5X ULN (upper limits of normal), or, for patients taking tolvaptan, as an ALT, AST, or direct bilirubin \>ULN * Known unstable cerebral aneurysm * Active coronary artery disease, defined as presence of stable or unstable angina * Systemic disease (other than hypertension) likely to contribute to kidney disease (e.g., lupus) * Current use of simvastatin \>20 mg or pravastatin \>40 mg daily. * Pregnancy or lactation * Hemoglobin \<10 g/dL * Implanted ferromagnetic objects * Use of an investigational product within prior 30 days or 5 half-lives, whichever is longer
๐Ÿ’Š

What it tests

  • Bempedoic Acid 180 MG Oral Tablet
  • Placebo Capsule(s)
๐Ÿ“

Where

3 sites
University of Maryland, Baltimore
Baltimore, United States
Tufts University Medical Center
Boston, United States
University of Vermont Medical Center
Burlington, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy