Lorundrostat + Dapagliflozin for Kidney Disease
Recruiting in Palo Alto (17 mi)
+44 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Mineralys Therapeutics Inc.
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a randomized, double-blind (DB), placebo controlled, crossover study with a two-period, two-sequence (2x2) design evaluating the efficacy and safety of 25 mg QD lorundrostat (an aldosterone synthase inhibitor \[ASI\]) in addition to a SGLT2i for the treatment of hypertension in subjects with CKD and albuminuria while receiving stable treatment with an Angiotensin-converting enzyme inhibitor (ACEi) or an Angiotensin receptor blocker (ARB). Subjects will be at least 18 years old with hypertension, and mild to severe CKD with albuminuria at the Screening Visit.
Do I have to stop taking my current medications?
The trial requires you to stay on a stable treatment with an ACE inhibitor or an Angiotensin receptor blocker for at least 2 months before screening. You cannot use epithelial sodium channel inhibitors or mineralocorticoid receptor antagonists from 4 weeks before screening and during the study.
What data supports the idea that Lorundrostat + Dapagliflozin for Kidney Disease is an effective drug?
The available research shows that dapagliflozin, a part of the Lorundrostat + Dapagliflozin combination, is effective in treating chronic kidney disease. In the DAPA-CKD trial, dapagliflozin significantly reduced the risk of kidney failure and prolonged survival in patients with chronic kidney disease, whether or not they had diabetes. The trial showed a 39% decline in the risk of worsening kidney function or kidney failure-related death. This suggests that the drug is effective in slowing down the progression of kidney disease and improving patient outcomes.
12345What safety data exists for Lorundrostat + Dapagliflozin in kidney disease treatment?
The safety data for Dapagliflozin, a component of the treatment, includes studies on its effects on kidney function. A post-authorization safety study assessed hospitalization for acute kidney injury in patients with type 2 diabetes using Dapagliflozin. Another study reviewed adverse events of SGLT2 inhibitors, including Dapagliflozin, in chronic kidney disease. Additionally, research has shown that SGLT2 inhibitors can reduce adverse kidney and cardiovascular events in patients with advanced diabetic kidney disease. However, specific safety data for the combination of Lorundrostat and Dapagliflozin is not detailed in the provided research.
678910Is the drug Lorundrostat a promising treatment for kidney disease?
The information provided focuses on dapagliflozin, which is shown to be effective in reducing kidney disease progression and related health issues. However, there is no specific information about Lorundrostat in the provided articles, so we cannot determine if it is a promising treatment for kidney disease based on this data.
124511Eligibility Criteria
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.Inclusion Criteria
I have been on a stable dose of ACE inhibitor or ARB medication for at least 2 months.
Your body mass index (BMI) is between 18 and 45.
Your blood pressure is between 135 and 160 mmHg when measured at the start of the study.
+3 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Group II: Cohort 1Experimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Triad Internal MedicineAsheboro, NC
Nephrology Associates, Pllc - Winston-SalemWinston-Salem, NC
Northwest Louisiana Nephrology, Llc - ShreveportShreveport, LA
Balboa Nephrology Medical Group, Inc. (BNMG) - California Institute of Renal Research (CIRR) - Chula VistaChula Vista, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Mineralys Therapeutics Inc.Lead Sponsor
References
An update on dapagliflozin for chronic kidney disease. [2022]Dapagliflozin is an oral agent for type 2 diabetes mellitus (T2DM) belonging to the sodium/glucose cotransporter 2 inhibitor (SGLT2-I) class of antihyperglycemic medications. In clinical trials, dapagliflozin has also been shown to reduce cardiovascular and major renal events. In the DAPA-CKD trial, dapagliflozin significantly reduced the composite renal outcome in patients with chronic kidney disease (CKD). Dapagliflozin represents a new pharmacologic option for reducing CKD progression in patients with and without diabetes.
Clinical Evaluation of Dapagliflozin in the Management of CKD: Focus on Patient Selection and Clinical Perspectives. [2022]Dapagliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor that was recently approved in the USA and the EU for the treatment of adults with chronic kidney disease (CKD) with or without diabetes mellitus (DM). The DAPA-CKD trial showed a 39% decline in the risk of worsening kidney function, onset of end-stage kidney disease, or kidney failure-related death. Patients with lower levels of eGFR and higher levels of albuminuria are among those who stand to gain the greatest absolute benefits. These benefits were similar in both patients with or without diabetes, thus undermining the hypothesis that these drugs mitigate glycemia-related nephrotoxicity. Suggested mechanisms for renal protection include hemodynamic effects; BP reduction and improving salt sensitivities and metabolic effects; and glucose, uric acid and triglycerides (TG)-lowering effects. There have been already many excellent reviews on dapagliflozin and CKD management. Most of them cover both efficacy and safety. This review will focus on clinical perspectives and patient selection for the practicing clinician.
Effects of Dapagliflozin in Stage 4 Chronic Kidney Disease. [2023]In the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) randomized, placebo-controlled trial, the sodium-glucose cotransporter 2 inhibitor dapagliflozin significantly reduced risk of kidney failure and prolonged survival in patients with CKD with or without type 2 diabetes.
In CKD, dapagliflozin reduced a composite of eGFR decline, end-stage kidney disease, or CV or renal mortality. [2021]Label="SOURCE CITATION">Heerspink HJ, Stefánsson BV, Correa-Rotter R, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020;383:1436-46. 32970396.
Dapagliflozin in people with chronic kidney disease. [2023]Commentary on: Heerspink HJL, Stefánsson BV, Correa-Rotter R, et al Dapagliflozin in patients with chronic kidney disease. N Engl J Med 2020;383:1436-46. Series Editor: Dr Teck Khong, DTB Associate Editor, Clinical Pharmacology, St George's, University of London, UK.
Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting. [2023]Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor approved to treat type 2 diabetes mellitus (T2DM), among other conditions. When dapagliflozin was approved in Europe for treating T2DM (2012), potential safety concerns regarding its effect on kidney function resulted in this post-authorization safety study to assess hospitalization for acute kidney injury (hAKI) among dapagliflozin initiators in a real-world setting.
Adverse Events of Sodium-Glucose Cotransporter-2 Inhibitors in Chronic Kidney Disease: A Retrospective Chart Review. [2022]The renal benefits of sodium-glucose cotransporter-2 inhibitors (SGLT2) are now well established, and these agents are recommended by the American Diabetes Association and Kidney Disease: Improving Global Outcomes guidelines for patients with type 2 diabetes and chronic kidney disease. However, the safety profile of SGLT2 inhibitors in chronic kidney disease is not as clear. We describe the adverse event rates of SGLT2 inhibitors, primarily empagliflozin, in Kaiser Permanente Southern California members with diabetic kidney disease.
The effect of dapagliflozin on renal function in patients with type 2 diabetes. [2021]Dapagliflozin's antihyperglycemic effects are mediated by inhibition of renal sodium-glucose cotransporter-2; therefore, renal safety of dapagliflozin was assessed.
Effect of the dual sodium-glucose co-transporter-1 and -2 inhibitor sotagliflozin on renal outcomes in type 1 diabetes and type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials. [2023]To investigate the renal safety profile of sotagliflozin, a novel sodium-glucose co-transporter-1 and -2 inhibitor, in patients with type 1 diabetes and type 2 diabetes, with or without renal impairment, as well as its efficacy in decreasing the risk of further renal events, with an emphasis on those with previous renal impairment.
SGLT2 inhibitors reduce adverse kidney and cardiovascular events in patients with advanced diabetic kidney disease: A population-based propensity score-matched cohort study. [2023]There were limited data on the efficacy and safety profile on use of sodium-glucose co-transporter 2 receptor (SGLT2) inhibitors in diabetic patients with advanced chronic kidney disease (CKD). We aimed to evaluate the efficacy, in terms of improvement in glycemic profile, kidney function, prevention of adverse kidney and cardiovascular events, and the safety profile of SGLT2 inhibitors in a group of diabetic patients at CKD stage 3B-5 from a real-world population-based cohort.
Efficacy and Safety of Dapagliflozin in Patients with Chronic Kidney Disease across the Spectrum of Frailty. [2023]A sizeable proportion of patients with chronic kidney disease (CKD) are reported to be frail. Here we examined the safety and efficacy of dapagliflozin in patients with CKD by frailty level.