Treatment of cardiovascular and renal disease in patients with chronic kidney disease MedDRA version: 21.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0 Level: PT Classification code 10001580 Term: Albuminuria System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: BAY 1101042 15mg GITS tablet
Product Code: BAY 1101042
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Runcaciguat
Current Sponsor code: BAY 1101042
Other descriptive n
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 1. Participant must be = 45 of age inclusive, at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Participants who have: • history of any of the following: - 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, and/or - diagnosis of hypertension (defined as systolic blood pressure [BP] values = 140 mmHg and/or diastolic BP values =90 mmHg) and on hypertension medication for at least 5 years • established atherosclerotic cardiovascular disease (e.g. coronary artery disease, peripheral arterial disease, cerebrovascular disease) or heart failure • a clinical diagnosis of CKD based on all of the following criteria: - (estimated) glomerular filtration rate (eGFR) = 25 mL/min/1.73 m2 but = 60 mL/min/1.73 m2 (acc. Percentage of decrease in eGFR [CKD EPI]) - persistent high albuminuria defined as urine albumin-to-creatinine ratio [UACR] of between 30 mg/g and 3000 mg/g in 2 first morning void samples (collected at least 1 week apart) - Stable treatment with angiotensin-converting enzyme inhibitor (ACEi) or angiotensin-receptor blocker (ARB) for the participant maximum tolerated labelled daily dose and otherwise stable antihypertensive treatment both for at least 3 months before randomization, without any adjustments to this therapy for at least 4 weeks prior to randomization. • Diabetes patients that are on SGLT2-inhibitor (SGLT: sodium glucose transport protein) have to be on stable treatment for at least 3 months before Screening visit. 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 216 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 216
Exclusion criteria
Exclusion criteria: Medical Conditions 1. Known non-diabetic and non-hypertension related renal diseases as autosomal dominant polycystic kidney disease, bilateral clinically relevant renal artery stenosis, lupus nephritis, or ANCA-associated vasculitis, IgA nephropathy without hypertension, or any other secondary glomerulonephritis 2. Clinical diagnoses of heart failure and persistent symptoms (New York Heart Association (NYHA class III - IV) 3. Uncontrolled hypertension indicated by >160 mmHg systolic BP or =100 mmHg diastolic BP 4. History of secondary hypertension (i.e., renal artery stenosis, primary aldosteronism, or pheochromocytoma). 5. Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 3 months prior to the planned randomization 6. Dialysis for acute renal failure within the previous 6 months prior to the planned randomization 7. Renal allograft in place or a scheduled kidney transplant within the next 18 weeks (being on a waiting list does not exclude the subject) 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. aspartate aminotransferase [AST] or Alanine aminotransferase [ALT] >3x upper limit of norm [ULN]). 9. Active malignancy other than treated squamous cell, carcinoma in situ, or basal cell carcinoma of the skin Prior/Concomitant Therapy 10. Non diabetic patients treated with SGLT-2 inhibitors 11. Combination use of ACEi and ARB within 3 months prior to randomization 12. Concomitant therapy with nitrates, PDE5 inhibitors including non-specific inhibitors (e.g. dipyridamole and theophylline), soluble guanylate cyclase [sGC] stimulators, renin inhibitors (within 4 weeks prior to randomization) 13. Participation in another clinical study or treatment with another investigational product 90 days prior to randomization 14. Previous randomization in this study Diagnostic Assessments 15. HbA1c >11%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the change in albuminuria by urinary albumin-to-creatinine ratio (UACR) after treatment with titrated doses of runcaciguat given once daily from baseline to day 57 (+/-3);Secondary Objective: To investigate the overall safety and tolerability of runcaciguat;Primary end point(s): Mean change in UACR from baseline to the average of multiple time points during treatment;Timepoint(s) of evaluation of this end point: From baseline up to day 57 (± 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of subjects with treatment emergent adverse event (TEAE) Number of subjects with early discontinuations;Timepoint(s) of evaluation of this end point: Number of subjects with TEAE: From first treatment administration up to end of follow up (Day 87±7) Number of subjects with early discontinuations: From first treatment administration up to end of treatment (Day 57±3) | — |
Countries
Austria, Belgium, Bulgaria, Denmark, Finland, Germany, Israel, Italy, Poland, Spain, Sweden
Contacts
Public ContactBayer Clinical Trial Contact
Bayer AG
Outcome results
None listed