← Back to Search

Aldosterone Synthase Inhibitor

Part B - Open Label for Chronic Kidney Disease

Phase 2

Recruiting

Research Sponsored by Mineralys Therapeutics Inc.

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 week 12 to week 20

Awards & highlights

Study Summary

This trial is being conducted to evaluate how well a medication called lorundrostat works in treating high blood pressure in people with chronic kidney disease (CKD) and high levels of a protein called album

Who is the study for?

This trial is for adults with chronic kidney disease and high levels of protein in their urine (albuminuria), who also have high blood pressure. They should be on stable heart medication (ACEi or ARB) for at least 2 months, with specific ranges of kidney function and body mass index.Check my eligibility

What is being tested?

The study tests Lorundrostat, a drug that may help control blood pressure by inhibiting aldosterone production, alone or combined with Dapagliflozin. It's divided into two parts to assess effectiveness and safety in different stages of kidney disease.See study design

What are the potential side effects?

Possible side effects include changes in blood pressure, electrolyte imbalances like high potassium levels, dizziness due to low blood pressure, potential worsening of kidney function, and typical drug-related reactions such as nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 to week 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12 to week 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 to week 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Change from baseline in automated office blood pressure (AOBP) SBP at Week 8

Part B: Incidence and severity of AEs

Secondary outcome measures

Part A: Change from Week 12 in AOBP SBP at Week 20

Part A: Percent change from baseline in 24-hour urine albumin to creatinine ratio (UACR) at Week 8

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part B - Open LabelExperimental Treatment1 Intervention

Group II: Part A - Cohort 2Experimental Treatment1 Intervention

Group III: Part A - Cohort 1Experimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mineralys Therapeutics Inc.Lead Sponsor

4 Previous Clinical Trials

2,400 Total Patients Enrolled

Frequently Asked Questions

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

What is the current capacity for patient enrollment in this clinical trial?

"Indeed, the details provided on clinicaltrials.gov indicate that this study is currently in the process of enrolling participants. The initial posting took place on December 14th, 2023 and the most recent update occurred on January 8th, 2024. The study aims to recruit a total of 80 individuals across five distinct locations."

Answered by AI

Are eligible patients able to enroll in this ongoing trial at the present time?

"Indeed, as per clinicaltrials.gov, this trial is actively seeking participants. The original posting date was December 14th, 2023 and the most recent update occurred on January 8th, 2024."

Answered by AI

At how many distinct locations is this medical trial being administered?

"Several medical centers, including Academic Medical Research Institute (AMRI) in Los Angeles, ClinCept LLC in Columbus, and Seacoast Kidney & Hypertension Specialists - Portsmouth Office in Portsmouth, are actively enrolling patients for this study. There are five additional locations as well."

Answered by AI

What is the level of safety observed in Part A - Cohort 2 for patients?

"Based on our assessment at Power, the safety rating for Part A - Cohort 2 is a 2. This determination aligns with it being a Phase 2 trial, where there exists limited data supporting safety but no evidence of efficacy yet established."

Answered by AI