Balcinrenone + Dapagliflozin for Chronic Kidney Disease
(MIRO-CKD Trial)
Recruiting in Palo Alto (17 mi)
+104 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: AstraZeneca
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you must stop all current medications, but you cannot use MRAs, potassium sparing diuretics, potassium binders, fludrocortisone, or strong/moderate CYP3A4 inducers or inhibitors within 4 weeks before screening and during treatment.
What data supports the idea that Balcinrenone + Dapagliflozin for Chronic Kidney Disease is an effective drug?
The available research shows that finerenone, a drug similar to Balcinrenone, has been effective in reducing the risk of kidney failure and heart complications in patients with chronic kidney disease and type 2 diabetes. In a study, finerenone reduced the occurrence of kidney failure and other serious kidney issues from 21.1% to 17.8%. It also showed a significant reduction in both kidney and heart-related problems when compared to a placebo. Although the research does not directly mention Balcinrenone + Dapagliflozin, the effectiveness of similar drugs like finerenone suggests potential benefits for this combination as well.
12345What safety data exists for Balcinrenone + Dapagliflozin in treating chronic kidney disease?
The safety data for dapagliflozin, a component of the treatment, is well-documented. Dapagliflozin (Farxiga) is approved to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease. It has been studied extensively for its efficacy, safety, and tolerability in treating type 2 diabetes and heart failure with reduced ejection fraction. Dapagliflozin is generally well-tolerated, with a safety profile consistent across various indications, as observed in trials like DECLARE-TIMI 58 and DAPA-HF. However, specific safety data for the combination of Balcinrenone and Dapagliflozin is not detailed in the provided research.
678910Is the drug dapagliflozin a promising treatment for chronic kidney disease?
Yes, dapagliflozin is a promising drug for chronic kidney disease. It is approved to reduce the risk of worsening kidney function, kidney failure, heart-related death, and hospital visits for heart failure in people with chronic kidney disease, whether or not they have type 2 diabetes.
2361112Eligibility Criteria
This trial is for adults with chronic kidney disease, specifically those who have protein in their urine (albuminuria). Participants should not be currently treated with Balcinrenone or Dapagliflozin. The study aims to find the best dose of a new combination drug.Inclusion Criteria
I have chronic kidney disease with a specific kidney function level.
Serum potassium ≥ 3.5 mmol/L to ≤ 5.0 mmol/L
UACR > 100 mg/g (10 mg/mmol) to ≤ 5000 mg/g (500 mg/mmol)
+2 more
Exclusion Criteria
I have not had a heart attack, stroke, or similar event in the last 3 months.
I haven't used specific heart or kidney medications in the last 4 weeks.
Hypotension defined as SBP < 100 mmHg
+10 more
Participant Groups
The study tests the effectiveness and safety of combining two drugs: Balcinrenone and Dapagliflozin, against using just Dapagliflozin. It's looking at how well this combo reduces protein levels in urine compared to the single drug.
3Treatment groups
Experimental Treatment
Active Control
Group I: Balcinrenone/dapagliflozin 40 mg/10 mgExperimental Treatment1 Intervention
Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Group II: Balcinrenone/dapagliflozin 15 mg/10 mgExperimental Treatment1 Intervention
Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Group III: Dapagliflozin 10 mgActive Control1 Intervention
Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research SiteSheffield, AL
Research SiteWaterloo, Canada
Research SiteNorfolk, VA
Research SiteGlendale, CA
More Trial Locations
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Who Is Running the Clinical Trial?
AstraZenecaLead Sponsor
References
Finerenone: First Approval. [2022]Finerenone (Kerendia®), a first-in-class, orally administered, selective, nonsteroidal mineralocorticoid receptor antagonist (MRA), is being developed by Bayer HealthCare Pharmaceuticals for the treatment of diabetic kidney disease (DKD) and heart failure (HF), including chronic HF (CHF). Finerenone has been approved in the USA to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end stage renal disease (ESRD), cardiovascular death, nonfatal myocardial infarction (MI), and hospitalization for HF in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Finerenone is undergoing regulatory assessment in the EU and in China. A phase III trial is investigating finerenone in patients who have HF with preserved ejection fraction. This article summarizes the milestones in the development of finerenone leading to this first approval to reduce the risk of serious kidney and heart complications in adults with CKD and T2D.
Finerenone - are we there yet with a non-steroidal mineralocorticoid receptor antagonist for the treatment of diabetic chronic kidney disease? [2022]Introduction: Chronic kidney disease occurs in 40% of subjects with diabetes and increases the risk of cardiovascular death three-fold, compared to having diabetes alone. The non-steroidal mineralocorticoid receptor antagonist finerenone protects against chronic kidney disease in animal models.Areas covered: This evaluation is of a phase 3 trial of finerenone; Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD). In FIDELIO-DKD, finerenone reduced the primary composite outcome of kidney failure, a sustained decrease of at least 40% in eGFR over four weeks, or death from renal causes, from 21.1% to 17.8%, with a good safety profile.Expert opinion: Finerenone is an effective mineralocorticoid receptor antagonist for the treatment of diabetic chronic kidney disease. Recently, glucagon-like peptide 1 (GLP-1) receptor agonists and sodium-glucose cotransporters 2 (SGLT-2) inhibitors have been added to the list of medicines for use in subjects with this condition. Although finerenone has a different mechanism of action to these medicines, it will need to be tested and shown to be effective in presence of these medicines in diabetic kidney disease, prior to widespread use.
Finerenone in Predominantly Advanced CKD and Type 2 Diabetes With or Without Sodium-Glucose Cotransporter-2 Inhibitor Therapy. [2023]FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the nonsteroidal, selective mineralocorticoid receptor (MR) antagonist finerenone in patients with CKD and type 2 diabetes (T2D). This analysis explores the impact of use of sodium-glucose cotransporter-2 inhibitor (SGLT-2i) on the treatment effect of finerenone.
[Finerenone (Kerendia®), a new weapon against the chronic kidney disease of a patient with type 2 diabetes]. [2023]Finerenone, a new nonsteroidal mineralocorticoid receptor antagonist, showed a significant reduction in a primary composite renal outcome in FIDELIO-DKD and a significant reduction in a primary composite cardiovascular outcome in FIGARO-DKD in patients with type 2 diabetes (T2D) and a chronic kidney disease (CKD). In a subsequent analysis that combined these two clinical trials (FIDELITY), the reduction becomes statistically significant when compared to placebo for both outcomes, with a hazard ratio of 0.86 (95 % confidence interval 0.78-0.95; P = 0.0018) for the cardiovascular outcome and 0.77 (0.67-0.88; P = 0.0002) for the renal outcome. Furthermore, all renal events occurred less frequently with finerenone than with placebo, including the progression to end-stage CKD independently of the baseline levels of glomerular filtration rate and albuminuria and regardless of associated medications (including gliflozins). The safety profile was excellent. However, a significant increase in serum potassium level was observed. Even if it is less pronounced than the increase usually seen with spironolactone, the risk of hyperkalemia requires some caution regarding both patient selection and monitoring. Finerenone (Kerendia®) is indicated in the treatment of CKD with albuminuria in adult patients with T2D. In Belgium, it is reimbursed with conditions in combination with a renin-angiotensin blocker.
Finerenone: a new mineralocorticoid receptor antagonist to beat chronic kidney disease. [2023]Clinical trials of the mineralocorticoid receptor antagonist (MRA) finerenone published recently suggest that they improve outcomes in patients with diabetic kidney disease (DKD). This review summarises key research from the last two years to provide clinicians with a synopsis of recent findings.
Antidiabetic Drug Approved to Reduce Risk of Kidney Disease. [2023]Dapagliflozin (Farxiga) is now approved to reduce the risk of declining kidney function, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease with or without type 2 diabetes.
Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. [2021]To review clinical evidence for the efficacy, safety, and tolerability of dapagliflozin (Farxiga-AstraZeneca), a sodium glucose cotransporter 2 inhibitor, as monotherapy or in combination with other hypoglycemic agents for the treatment of type 2 diabetes.
Dapagliflozin/Saxagliptin Fixed-Dose Tablets: A New Sodium-Glucose Cotransporter 2 and Dipeptidyl Peptidase 4 Combination for the Treatment of Type 2 Diabetes. [2022]To review the pharmacology, pharmacokinetics, efficacy, safety, and place in therapy of the fixed-dose combination (FDC) product, QTERN (dapagliflozin/saxagliptin) tablets.
Dapagliflozin: A Review in Symptomatic Heart Failure with Reduced Ejection Fraction. [2022]Dapagliflozin [Farxiga® (USA); Forxiga® (EU)], a sodium-glucose cotransporter 2 (SGLT2) inhibitor, was recently approved in the USA and the EU for the treatment of adults with symptomatic heart failure with reduced ejection fraction (HFrEF). The cardiovascular (CV) benefits of dapagliflozin were first observed in the DECLARE-TIMI 58 trial, in which dapagliflozin 10 mg/day significantly reduced the risk of CV death or hospitalization for HF in patients with type 2 diabetes mellitus (T2DM) who had or were at risk for atherosclerotic CV disease. In the subsequent DAPA-HF trial, dapagliflozin 10 mg/day in addition to standard of care was associated with a significantly lower risk of worsening HF or CV death than placebo in patients with HFrEF, regardless of the presence or absence of T2DM. The benefits of dapagliflozin also remained consistent regardless of background HF therapies. Dapagliflozin was generally well tolerated, with an overall safety profile consistent with its known safety profile in other indications. In conclusion, dapagliflozin is an effective and generally well-tolerated treatment that represents a valuable new addition to the options available for symptomatic HFrEF.
Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. [2021]Dapagliflozin (DAPA) (Farxiga or Forxiga) is a sodium glucose cotransporter 2 (SGLT2) inhibitor approved for type 2 diabetes mellitus(T2DM) treatment.
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.
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.