A trial to learn more about how BAY 2327949 works and how safe it is in participants with chronic kidney disease

Phase 1

• Conditions: Chronic Kidney Disease; MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-002192-35-SE
• Lead Sponsor: Bayer - AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-12
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Participant must be 45 years or older at the time of signing the informed consent.
2. A clinical diagnosis of CKD meeting all of the following criteria:
?eGFR = 25 mL/min/1.73 m² but = 60 mL/min/1.73 m² (estimated using the CKD-EPI equation) as assessed during Visit 1
?albuminuria (as measured by UACR) in the range of = 30 but = 3000 mg/g, based on the first assessment for Visit 1
3. history of at least one of the following as clinical cause for CKD:
? 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
and/or
? Diagnosis of hypertension (defined as systolic BP values = 140 mmHg and/or diastolic BP values = 90 mmHg) and on hypertension medication for at least 5 years before randomization
4. History of at least one of the following:
? established atherosclerotic vascular disease (e.g. coronary artery disease, peripheral arterial disease, cerebrovascular disease)
? pulmonary heart disease
? heart failure
5. Stable treatment with either ACE inhibitors or 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.
6. Body mass index within the range of 18-38 kg/m² as evaluated for Visit 1.
7. Male or female. Male participants must agree to use barrier contraception (condoms). Female participants must be of non-child-bearing potential
8. Capable of giving signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72

Exclusion Criteria

1. 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)
2. Clinical diagnoses of heart failure and persistent symptoms (NYHA class III – IV), or hospitalization for worsening heart failure in the last 3 months prior to signing the ICF
3. 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
4. History of secondary hypertension (i.e., renal artery stenosis, primary aldosteronism, or pheochromocytoma)
5. Stroke, transient ischemic cerebral attack, acute coronary syndrome in the last 3 months prior to signing the ICF
6. Dialysis for acute renal failure within the previous 6 months prior to signing the ICF
7. 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)
8. 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)
9. Active malignancy. Previous malignancies are allowed if there is a 5-year remission- and treatment-free time before signing the ICF
10. 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 including but not limited to:
History of active inflammatory bowel disease within the last 6 months before signing ICF
? Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
? Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last 6 months before signing ICF (treated duodenal ulcers without bleeding are allowed)
? Pancreatic injury or pancreatitis within the last 6 months before signing ICF
? A positive test result for SARS-CoV-2 or a diagnosis of COVID-19 within 2 months before signing the ICF
11. Evidence of urinary obstruction, e.g. requirement for catheterization or inability to provide urine samples
12. Acute or chronic urinary tract infection with bacteriuria, leukocyturia, or hematuria (microscopic investigation to be done upon positive dipstick testing, and participants with hematuria with >5/HPF erythrocytes are excluded from participating in this study)
13. Known hypersensitivity to any ingredient of the study intervention
14. For participants without diabetes: receiving off-label treatment with an SGLT2 inhibitor
15. Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to signing ICF
16. Combination use of an ACE inhibitor and ARB within 3 months prior to signing ICF
17. Concomitant therapy with drugs that strongly induce or inhibit CYP3A4, or that are inhibitors of P-gp
18. Planned change of concomitant medications or dose adjustments during participation in this study
19. Participation in another clinical study with treatment with another investigational product 90 days prior to signing ICF
20. Previous randomization in this study or re-screened more t

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified