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Research Study for Chronic Kidney Disease and High Blood Pressure

Enrolling at: Toronto · Sarnia · Montreal
Phase 3Study phase
≈3 yearsStudy length
18+Age range
3 sitesResearch locations

About this study

Do you suffer from Chronic Kidney Disease (CKD) and Hypertension (HTN)?

This clinical research study is looking at the safety and effectiveness of an investigational medication option for volunteers with chronic kidney disease.

The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of > 50% decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN.

This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin.

Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomization. Thereafter visits will occur approximately every 4 months.

Would you like to take part in CKD Research?

As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow up of your condition to monitor the safety and effectiveness of the care you’ll receive. Study volunteers are an important part of moving medical care forward.

Who may qualify

You may qualify if
  • Are of any sex and gender ≥ 18 years of age at the time of signing the informed consent.
  • Have:
    1. eGFR ≥ 30 and < 60 mL/min/1.73 m2 (local or central laboratory values) AND UACR ≥ 30 mg/g (3.39 mg/mmol) and < 500 mg/g (56.5 mg/mmol) (central laboratory values only), or
    2. eGFR ≥ 30 and ≤ 75 mL/min/1.73 m2 (local or central laboratory values) AND UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) or UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local or central laboratory values).
  • Have a history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.
  • Are on a stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.
  • Have:
    1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values).
    2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2 (local or central laboratory values)
This study may not be a fit if
  • Have systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening.
  • Have known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months prior to screening.
  • Have serum sodium < 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).
  • Have type 1 diabetes mellitus
  • Have uncontrolled type 2 diabetes mellitus with HbA1c > 10.5% (> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).
  • Display New York Heart Association functional HF class IV at screening.
  • Have had any stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation.
  • Have documented history of adrenal insufficiency.
  • Have had any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
  • Have had any acute kidney injury within 3 months prior to the Screening Visit.
  • Have a history of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
  • Have had any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).
Every study has additional criteria the research site will review with you.

What participation may involve

  • Regular visits with the study team at no cost
  • Study assessments and health monitoring throughout
  • Check-ins between visits
  • Informed consent before anything begins — questions welcome
Time commitment: ≈3 years — confirmed by the research site. The full visit schedule is explained during informed consent.

What participants may receive

  • Study-related care from a physician-led team
  • Study assessments at no cost
  • Reimbursement for reasonable travel, where applicable
Specifics vary by study and site, and are never a guarantee of benefit. Being in a study is not a substitute for regular medical care.
Participating research sites

Where this study is enrolling

TORONTO, ONAlbion Finch Medical CentrePrincipal investigator: Dr. Anil K. GuptaView site →SARNIA, ONBluewater Clinical Research GroupPrincipal investigator: Dr. John O’Mahony, Dr. Sean PetersonView site →MONTREAL, QCEndocrinologie OasisPrincipal investigator: Dr. Zeina YaredView site →

Learn more

About the condition

Cardiovascular disease

Cardiovascular disease is a group of conditions affecting the heart and the blood vessels that carry blood around your body. The most common form in Canada is ischemic…

Learn about this condition →
About the condition

Chronic Kidney Disease

Your kidneys filter waste and extra fluid out of the blood, help control blood pressure, and keep minerals in balance. Chronic kidney disease means that filtering has been…

Learn about this condition →
About the condition

Hypertension (high blood pressure)

Blood pressure is the force of blood pushing against the walls of your arteries. Hypertension, or high blood pressure, means that force stays higher than it should over…

Learn about this condition →
About the condition

Kidney and Liver Diseases

The kidneys filter your blood and keep fluid and minerals in balance. The liver processes food, medicines and waste, and makes proteins your body needs every day. Both…

Learn about this condition →
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Common questions

Do I have to decide now?
No. Answering the questions is not a commitment — it simply lets the research team see whether this study may be appropriate and contact you to talk it through.
Will it cost me anything?
No. Study visits and study assessments are provided at no cost, and reasonable travel may be reimbursed where applicable.
What happens after I submit the form?
A member of the research team reviews your answers and contacts you — usually within two business days — to answer questions and review the next steps.
Could I receive a placebo?
Some studies compare a treatment with a placebo. Whether this study does is explained clearly during informed consent, before you decide anything.
Can I leave the study after it starts?
Yes. Participation is always voluntary. You can withdraw at any time without giving a reason and without it affecting your regular medical care.
Request contact

Ask the research site to contact you

Your answers go only to the research site, help the team prepare before they call — and completing the form doesn’t obligate you to take part.
JAS Study Interest (Stream A)

See if you may qualify

A few quick questions — about a minute. Your answers help the research team prepare before they contact you.

For anyone under 18, a parent or legal guardian should complete this form and would need to consent on their behalf.

See if you may qualify →

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