Trial Condition(s):

Chronic Kidney Disease

Study on the safety of the drug runcaciguat and how well it works when given at the highest dose as tolerated by individual patient whose kidneys are not working properly and suffering at the same time from high blood sugar and/or high blood pressure and a disease of the heart and the blood vessels. (CONCORD)

Bayer Identifier:

18748

ClinicalTrials.gov Identifier:

NCT04507061

EudraCT Number:

2019-003297-53

EU CT Number:

Not Available

Study Completed

Trial Purpose

Researchers in this study want to learn more about the safety of the drug runcaciguat and how well it works when given at the highest dose as tolerated by the individual patient whose kidneys are not working properly and suffering at the same time from high blood sugar and/or high blood pressure and a disease of the heart and the blood vessels. Runcaciguat is a new drug under development for the improvement of kidney function. It works by activating proteins that helps to dilate blood vessels, including vessels in the kidneys. This can improve blood flow in kidney and may slow down the progression of kidney disease. This dilative effect can also influence the heart rate and blood pressure. Researchers also wants to find the best dose of the drug during the study.

Participants in this study will receive either runcaciguat or placebo tablets every morning for 8 weeks. A placebo looks like the study drug but does not have any active medicine in it. On a weekly basis, the dose of the runcaciguat will be increased step by step. In total, participants will visit the doctors about 10 times, and the observation will last for about 16 weeks. Blood and urine samples will collected from the participants.

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:
a. History of active inflammatory bowel disease within the last 6 months before randomization;
b. Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
c. Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last 6 months before randomization;
d. 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%;

Trial Summary

Enrollment Goal
243
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Runcaciguat (BAY1101042)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Locations
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Klinikum der Universität Würzburg

Wuerzburg, Germany, 97080

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DaVita Clinical Research Deutschland GmbH

Duesseldorf, Germany, 40210

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Medamed Studienambulanz GmbH

Leipzig, Germany, 04315

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InnoDiab Forschung GmbH

Essen, Germany, 45136

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Istituto Ricerche Farmacologiche Mario Negri IRCCS

Bergamo, Italy, 24020

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A.O.U. di Bologna Policlinico S.Orsola Malpighi

Bologna, Italy, 40138

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IRCCS Ospedale Policlinico San Martino

Genova, Italy, 16132

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A.O.U. Luigi Vanvitelli

Napoli, Italy, 80131

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Hospital Universitario Virgen de las Nieves|Medicina Interna

Granada, Spain, 18014

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Hospital Quironsalud Barcelona | Internal Medicine Department

Barcelona, Spain, 08023

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Hospital del Mar

Barcelona, Spain, 08003

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Complejo Hosp. Univ. A Coruña | Endocrinologia y Nutricion

A Coruña, Spain, 150006

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Hospital Universitario Dr. Peset

Valencia, Spain, 46017

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Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

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Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial

Ferrol, Spain, 15405

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Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08023

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UZ Gent

GENT, Belgium, 9000

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UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

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Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

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OL Vrouwziekenhuis - Campus Aalst

Aalst, Belgium, 9300

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Ospedale San Raffaele s.r.l.

Milano, Italy, 20132

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Klinik Landstraße - Krankenhaus Rudolfstiftung

Wien, Austria, 1030

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Medizinische Universität Innsbruck

Innsbruck, Austria, 6020

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Universitätsklinikum AKH Wien

Wien, Austria, 1090

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Regionshospitalet Gødstrup

Herning, Denmark, 7400

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Region Nordjylland | Aalborg University Hospital - Cardiology Department

Aalborg, Denmark, 9000

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Holbæk Sygehus

Holbæk, Denmark, 4300

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Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme

Kolding, Denmark, 6000

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Steno Diabetes Center Copenhagen

Herlev, Denmark, 2730

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Turun yliopistollinen keskussairaala

Turku, Finland, 20521

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Diagnos Klaukkalan Lääkäriasema

Klaukkala, Finland, 01800

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StudyCor Oy

Jyväskylä, Finland, 40620

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Omena Terveys Oy

Seinäjoki, Finland, 60320

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Barzilai Medical Center | Nephrology & Hypertension Dept.

Ashkelon, Israel, 7830604

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Chaim Sheba Medical Center

Ramat Gan, Israel, 5262000

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PTC-Primary care Trial Center

Göteborg, Sweden, 413 46

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Clemenstorget Hjärtmottagning

Lund, Sweden, 222 21

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ClinSmart

Uppsala, Sweden, 752 37

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Satucon / Kuopion Työterveys

Kuopio, Finland, 70100

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Centralny Szpital Kliniczny MSWiA w Warszawie

Warszawa, Poland, 02-507

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MCOMH Preventsia-2000

Stara Zagora, Bulgaria, 6000

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Med Centre Diamedical 2013

Dimitrovgrad, Bulgaria, 6400

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MC Kalimat

Sofia, Bulgaria, 1680

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Multiprofile Hospital for Active Treatment Sveta Karidad | Cardiology Department

Plovdiv, Bulgaria, 4004

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Multiprofile Hospital for Active Treatment Medline Clinic

Plovdiv, Bulgaria, 4000

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MHAT Dr. Bratan Shukerov AD

Smolyan, Bulgaria, 4700

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Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department

Sofia, Bulgaria, 1233

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Health Corporation of Galilee Medical Center

Nahariya, Israel, 2210001

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Poriya Medical Center | Nephrology and Hypertension Dept.

Tiberius, Israel, 1528001

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Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel, 9112001

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Clalit Health Services Rabin Medical Center-Beilinson Campus

Petah Tikva, Israel, 4941492

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Edith Wolfson Medical Center

Holon, Israel, 5822012

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Lady Davis Carmel Medical Center

Haifa, Israel, 3436212

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IRCCS Centro Cardiologico Monzino S.p.A

Milano, Italy, 20138

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Akademiska Sjukhuset Njurmottagningen

Uppsala, Sweden, 751 85

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Odense Universitetshospital, Endokrinologisk Afd. M

Odense C, Denmark, 5000

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Klinik Hietzing

Wien, Austria, 1130

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Zentrum f. klinische Studien Dr. Hanusch GmbH

Wien, Austria, 1060

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Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)

Bad Oeynhausen, Germany, 32545

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Kyiv City Center of Nephrology and Dialysis

Kyiv, Ukraine, 02660

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Private enterprise private production company " Acinus"

Kropyvnytskyi, Ukraine, 25006

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Dnepropetrovsk regional hospital n.a. I. I. Mechnikov

Dnipro, Ukraine, 49005

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Ternopil Regional Clinical Hospital

Ternopil, Ukraine, 46002

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Kyiv City Center of Nephrology and Dialysis

Kyiv, Ukraine, 01023

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Medical Center of Edelweiss Medics LLC

Kyiv, Ukraine, 02002

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Volyn Regional Clinical Hospital

Lutsk, Ukraine, 43005

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Zaporizhzhia Regional Clinical Hospital

Zaporizhzhya, Ukraine, 69600

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FMC-dialyzacne sluzby, s.r.o. - Kosice

Kosice, Slovakia, 04011

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BIODIAL, spol. s r.o.

Puchov, Slovakia, 02001

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Medivasa s.r.o.

Zilina, Slovakia, 01001

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Medical center LLC " Fresenius medical care Ukraine»

Cherkasy, Ukraine, 18009

Trial Design