CONCORDRuncaciguat Individualizado para Enfermedad Renal Crónica con Diabetes/Hipertensión y Comorbilidad Cardiovascular

Fecha de inicio: 1 de septiembre de 2020

Inclusion Criteria: Age - Participant must be ≥ 45 of age inclusive, at the time of signing the informed consent. Type of Participant and Disease Characteristics \- 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 chronic kidney disease (CKD) based on all of the following criteria: * (estimated) glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m\^2 but ≤ 60 mL/min/1.73 m\^2 (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. Exclusion Criteria: * 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; * Clinical diagnoses of heart failure and persistent symptoms (New York Heart Association (NYHA class III - IV); * Uncontrolled hypertension indicated by \>160 mmHg systolic BP or ≥ 100 mmHg diastolic BP; * History of secondary hypertension (i.e., renal artery stenosis, primary aldosteronism, or pheochromocytoma); * Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 3 months prior to the planned randomization; * Dialysis for acute renal failure within the previous 6 months prior to the planned randomization; * Renal allograft in place or a scheduled kidney transplant within the next 18 weeks (being on a waiting list does not exclude the subject); * 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 \[ULN\]); * Active malignancy other than treated squamous cell, carcinoma in situ, or basal cell carcinoma of the skin Prior/Concomitant Therapy; * Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study including but not limited to: 1. History of active inflammatory bowel disease within the last 6 months before randomization; 2. Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; 3. Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last 6 months before randomization; 4. Pancreatic injury or pancreatitis within the last 6 months before randomization; * Non diabetic patients treated with SGLT-2 (SGLT:sodium glucose transport protein) inhibitors; * Combination use of ACEi and ARB within 3 months prior to randomization; * Concomitant therapy with nitrates, PDE5 inhibitors including nonspecific inhibitors (e.g. dipyridamole and theophylline), soluble guanylate cyclase \[sGC\] stimulators, renin inhibitors (within 4 weeks prior to randomization); * Participation in another clinical study or treatment with another investigational product 90 days prior to randomization; * Previous randomization in this study; * hemoglobin A1c (HbA1c) \>11%;