Baxdrostat + Dapagliflozin for Chronic Kidney Disease
Recruiting in Palo Alto (17 mi)
+504 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: AstraZeneca
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone.
Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.
Is the drug Baxdrostat + Dapagliflozin a promising treatment for chronic kidney disease?Yes, the drug Dapagliflozin, part of the Baxdrostat + Dapagliflozin combination, is promising for chronic kidney disease. It has been shown to reduce the risk of kidney failure, heart-related deaths, and hospitalizations. It also slows down kidney damage, making it a valuable option for people with or without diabetes.457810
What data supports the idea that Baxdrostat + Dapagliflozin for Chronic Kidney Disease is an effective drug?The available research shows that Dapagliflozin, which is part of the Baxdrostat + Dapagliflozin combination, is approved to reduce the risk of worsening kidney function, kidney failure, and heart-related issues in people with chronic kidney disease. This suggests that the drug is effective in managing the condition. However, there is no specific data provided on the combination of Baxdrostat + Dapagliflozin, so the effectiveness of the combination specifically is not detailed in the available information.13459
What safety data is available for the treatment with Baxdrostat and Dapagliflozin for chronic kidney disease?Dapagliflozin, also known as Farxiga or Forxiga, has been 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. It has been reviewed for its safety and tolerability as a monotherapy or in combination with other hypoglycemic agents for type 2 diabetes. However, it is no longer authorized for the treatment of type 1 diabetes. The safety of the combination with Baxdrostat specifically may not be covered in the provided research.12456
Do I have to stop taking my current medications for the trial?The trial does not specify if you need to stop all current medications. However, you must be on a stable and maximum tolerated dose of an ACE inhibitor or an ARB for at least 4 weeks before the screening. You cannot use mineralocorticoid receptor antagonists, potassium-sparing diuretics, or potassium binders within 4 weeks before screening.
Eligibility Criteria
This trial is for adults with chronic kidney disease (CKD) and high blood pressure. Participants should not have previously used SGLT2 inhibitors, a type of diabetes medication. They must be willing to take the study drugs and visit the site regularly over two years.Inclusion Criteria
My kidney function is reduced but not severely (eGFR between 30 and 90).
I have high blood pressure with readings of at least 130 mmHg during screening and 120 mmHg when joining the study.
I am 18 years or older and can give informed consent.
Exclusion Criteria
I have Type 1 diabetes or my Type 2 diabetes is not under control with an HbA1c over 10.5%.
My heart failure is severe, limiting my physical activity significantly.
I have had or will have an organ or bone marrow transplant.
I have been on stable immunosuppression therapy for over 3 months.
Participant Groups
The trial tests if baxdrostat combined with dapagliflozin can slow down CKD progression better than dapagliflozin alone in patients with CKD and hypertension. It's a double-blind study, meaning neither participants nor researchers know who gets which treatment until after the results are collected.
2Treatment groups
Experimental Treatment
Active Control
Group I: Baxdrostat/dapagliflozinExperimental Treatment1 Intervention
Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.
Group II: DapagliflozinActive Control1 Intervention
Patients will receive one dose of dapagliflozin (active comparator) in combination with placebo matching baxdrostat daily
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Research SiteWoodbridge, VA
Research SiteWichita, KS
Research SiteUpper Marlboro, MD
Research SitePontiac, MI
More Trial Locations
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Who is running the clinical trial?
AstraZenecaLead Sponsor
References
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: 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 (forxiga®) : SGLT 2 cotransporter inhibitor as glucose-lowering agent in type 2 diabetes]. [2021]Dapagliflozin, a specific inhibitor of sodium-glu¬cose cotransporters type 2 (SGLT2, inhibits glucose reabsorp¬tion in renal tubules and thus promotes glucosuria. This effect results in a reduction in fasting and postprandial glycaemia and a decrease of glycated haemoglobin (HbA1c), with a minor risk of hypoglycaemia, a weight reduction and a reduction in arterial blood pressure. The efficacy of empagliflozin on HbA1c reduction increases according to the level of hyper¬glycaemia but decreases in patients with renal insufficiency. Mycotic genital infections occur more frequently, especially in women, while a negligible increase in mild urinary tract infections may be observed. Dapagliflozin (Forxiga®), 10 mg once daily, is indicated for the treatment of T2DM and reim¬bursed in Belgium with conditions as add-on to a background glucose-lowering therapy (either metformin or sulfonylurea/ repaglinide or metformin plus sulfonylurea/repaglinide or basal insulin plus at least one of these oral glucose-lowering agents). Preliminary results suggest some cardiovascular and renal protection. These results should be confirmed in an ongoing large prospective controlled trial (DECLARE) in type 2 diabetic patients at high cardiovascular risk.
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.
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 no longer licensed for type 1 diabetes. [2022]Overview of: Medicines and Healthcare products Regulatory Agency. Dapagliflozin (Forxiga): no longer authorised for treatment of type 1 diabetes mellitus. Drug Safety Update 2021;15:3.
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.
Extrapolated longer-term effects of the DAPA-CKD trial: a modelling analysis. [2023]The Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial assessed dapagliflozin versus placebo, in addition to standard therapy, in patients with chronic kidney disease (CKD) and albuminuria, and was terminated prematurely due to overwhelming efficacy. The study objective was to model the long-term clinical outcomes of DAPA-CKD beyond the trial follow-up.
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.
The proteinuria-lowering effects of dapagliflozin are associated with an initial decline in estimated glomerular filtration rate in patients with chronic kidney disease. [2023]Sodium-glucose co-transporter-2 inhibitor, dapagliflozin (DAPA) reduced albuminuria and slowed down the decline in estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease (CKD) in the DAPA-CKD trial. However, proteinuria (albuminuria) does not necessarily decrease in all patients in real-world clinical settings. Therefore, we aimed to identify the clinical characteristics of patients with CKD and decreased proteinuria in response to DAPA treatment.