ADPKD study: Bempedoic Acid
Official title Bempedoic Acid Therapy for Polycystic Kidney Disease
ClinicalTrials.gov ID: NCT07282821
What this study is testing
What is Bempedoic Acid 180 MG Oral Tablet?
Bempedoic Acid 180 MG Oral Tablet is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for adpkd (autosomal dominant polycystic kidney disease).
Also referred to as Nexletol.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether bempedoic acid is safe, tolerable, and shows early signs of slowing kidney disease in people with autosomal dominant polycystic kidney disease.
- Who it's for
- Adults with ADPKD whose disease is progressing quickly and whose kidney function (eGFR) is 35 ml/min/1.73 m² or higher.
- What's involved
- Participants will take either bempedoic acid or a placebo pill for two years, with regular clinic visits, blood and urine tests, and MRI scans to measure kidney and liver cyst size and other health markers.
- Time commitment
- The trial lasts about two years and includes periodic visits for labs, imaging, and safety checks.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- Estimated glomerular filtration rate (eGFR) ≥35 ml/min/1.73m2 by CKD-Epi equation utilizing creatinine
- Fluent English-speaking
You likely can't join if
- 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...
See the full eligibility 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) ≥35 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 ≥3 months
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Burlington, Vermont, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States; Boston, Massachusetts, United States; Burlington, Vermont, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.