Status:
WITHDRAWN
A Trial to Learn More About How BAY2327949 Works and How Safe it is in Patients Whose Kidneys Are Damaged Due to High Blood Sugar Levels or High Blood Pressures, and With a Further Disease of the Heart or the Blood Vessels.
Lead Sponsor:
Bayer
Conditions:
Chronic Kidney Disease
Diabetic Kidney Disease
Eligibility:
All Genders
45+ years
Phase:
PHASE2
Brief Summary
In people with type 2 diabetes (T2D), the body makes insulin, but cannot use it well. This results in high blood sugar levels causing damage to the blood vessels inside the kidneys. High blood pressu...
Eligibility Criteria
Inclusion
- A clinical diagnosis of chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m\^2 but ≤ 60 mL/min/1.73 m\^2 (estimated using the CKD-EPI \[Epidemiology Collaboration\] equation) as assessed during Visit 1, and albuminuria (as measured by urine albumin-to-creatinine ratio \[UACR\]) in the range of ≥ 30 but ≤ 3000 mg/g, based on the first assessment for Visit 1.
- CKD with a clinical cause of either T2D or hypertension: -- if T2D is the clinical cause, history of type 2 diabetes mellitus as defined by the American Diabetes Association (on treatment with glucose-lowering medications and/or insulin) for at least 2 years before randomization and on a stable therapy with sodium-glucose transport protein 2 (SGLT2) inhibitor for at least 3 months before randomization; -- if hypertension is the clinical cause, patients must have a history of systolic blood pressure (BP) values ≥ 140 mmHg and/or diastolic BP values ≥ 90 mmHg, and on hypertension medication for at least 5 years before randomization.
- Stable treatment with either angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) at the maximal tolerated labelled daily dose and otherwise stable antihypertensive treatment both for at least 3 months before randomization. If taking an SGLT2 inhibitor, the participant must be on stable treatment for at least 3 months before randomization without any planned changes in dosing during the study period. All treatments must be expected to remain stable over the study period without any planned dose adjustments.
- Body mass index within the range of 18-38 kg/m\^2 as evaluated for Visit 1.
- Male participants must agree to use barrier contraception (condoms). Female participants must be of non-child-bearing potential.
Exclusion
- Known non-diabetic or non-hypertensive renal disease (e.g. autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, bilateral clinically relevant renal artery stenosis, lupus nephritis, or ANCA-associated vasculitis, or any other secondary glomerulonephritis).
- Clinical diagnoses of heart failure and persistent symptoms (NYHA \[New York Heart Association\] class III - IV), or hospitalization for worsening heart failure in the last 3 months prior to signing the informed consent form (ICF).
- Uncontrolled hypertension indicated by \>160 mmHg systolic BP or ≥100 mmHg diastolic BP at Visit 1 or Visit 2 or at any unscheduled visit before randomization.
- History of secondary hypertension (i.e., renal artery stenosis, primary aldosteronism, or pheochromocytoma); stroke, transient ischemic cerebral attack, acute coronary syndrome in the last 3 months prior to signing the ICF.
- Dialysis for acute renal failure within the previous 6 months prior to signing the ICF.
- Renal allograft in place or a scheduled kidney transplant within the next 18 weeks from signing the ICF (being on a waiting list does not exclude the participant).
- Hepatic insufficiency classified as Child-Pugh B or C or other significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated by e.g. AST/ALT \>3x ULN).
- Active malignancy. Previous malignancies are allowed if there is a 5-year remission- and treatment-free time before signing the ICF.
- Any surgical or medical condition, which in the opinion of the investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.
- For participants without diabetes: receiving off-label treatment with an SGLT2 inhibitor.
- Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to signing ICF.
- Combination use of an ACE inhibitor and ARB within 3 months prior to signing ICF.
- Concomitant therapy with drugs that strongly induce or inhibit CYP3A4 (cytochrome P-450 3A4), or that are inhibitors of P-gp (P-glucoprotein).
- Planned change of concomitant medications or dose adjustments during participation in this study.
- Participation in another clinical study with treatment with another investigational product 90 days prior to signing ICF.
- HbA1c \> 11% at Visit 1.
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04661917
Start Date
May 31 2021
End Date
May 19 2022
Last Update
May 21 2021
Active Locations (36)
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1
Medizinische Universität Graz
Graz, Styria, Austria, 8036
2
Konventhospital Barmherzige Brüder Linz
Linz, Upper Austria, Austria, 4021
3
Landeskrankenhaus Feldkirch
Feldkirch, Vorarlberg, Austria, 6807
4
Universitätsklinikum St. Pölten
Sankt Pölten, Austria, 3100