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

September2020

April2022

Phase

Could I receive a placebo?

Yes

Products

Runcaciguat (BAY1101042)

Accepts Healthy Volunteers

Where to Participate

Locations

Locations
Locations Klinikum der Universität Würzburg Wuerzburg, Germany, 97080	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations DaVita Clinical Research Deutschland GmbH Duesseldorf, Germany, 40210	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Medamed Studienambulanz GmbH Leipzig, Germany, 04315	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations InnoDiab Forschung GmbH Essen, Germany, 45136	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Istituto Ricerche Farmacologiche Mario Negri IRCCS Bergamo, Italy, 24020	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna, Italy, 40138	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations IRCCS Ospedale Policlinico San Martino Genova, Italy, 16132	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations A.O.U. Luigi Vanvitelli Napoli, Italy, 80131	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Hospital Universitario Virgen de las Nieves\|Medicina Interna Granada, Spain, 18014	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Hospital Quironsalud Barcelona \| Internal Medicine Department Barcelona, Spain, 08023	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Hospital del Mar Barcelona, Spain, 08003	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Complejo Hosp. Univ. A Coruña \| Endocrinologia y Nutricion A Coruña, Spain, 150006	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Hospital Universitario Dr. Peset Valencia, Spain, 46017	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Complejo Hospitalario Universitario de Ferrol \| Hospital Naval - Unidad de Hipertensión Arterial Ferrol, Spain, 15405	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08023	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations UZ Gent GENT, Belgium, 9000	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Hôpital Erasme/Erasmus Ziekenhuis BRUXELLES - BRUSSEL, Belgium, 1070	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations OL Vrouwziekenhuis - Campus Aalst Aalst, Belgium, 9300	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Ospedale San Raffaele s.r.l. Milano, Italy, 20132	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Klinik Landstraße - Krankenhaus Rudolfstiftung Wien, Austria, 1030	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Medizinische Universität Innsbruck Innsbruck, Austria, 6020	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Regionshospitalet Gødstrup Herning, Denmark, 7400	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Region Nordjylland \| Aalborg University Hospital - Cardiology Department Aalborg, Denmark, 9000	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Holbæk Sygehus Holbæk, Denmark, 4300	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Sygehus Lillebaelt \| Kolding Sygehus - Medicinske Sygdomme Kolding, Denmark, 6000	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Steno Diabetes Center Copenhagen \| Herlev - Clinical and Translational Research Department Herlev, Denmark, 2730	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Turun yliopistollinen keskussairaala Turku, Finland, 20521	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Diagnos Klaukkalan Lääkäriasema Klaukkala, Finland, 01800	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations StudyCor Oy Jyväskylä, Finland, 40620	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Omena Terveys Oy Seinäjoki, Finland, 60320	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Barzilai Medical Center \| Nephrology & Hypertension Dept. Ashkelon, Israel, 7830604	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Chaim Sheba Medical Center Ramat Gan, Israel, 5262000	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations PTC-Primary care Trial Center Göteborg, Sweden, 413 46	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Clemenstorget Hjärtmottagning Lund, Sweden, 222 21	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations ClinSmart Uppsala, Sweden, 752 37	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Satucon / Kuopion Työterveys Kuopio, Finland, 70100	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Centralny Szpital Kliniczny MSWiA w Warszawie Warszawa, Poland, 02-507	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations MCOMH Preventsia-2000 Stara Zagora, Bulgaria, 6000	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Med Centre Diamedical 2013 Dimitrovgrad, Bulgaria, 6400	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations MC Kalimat Sofia, Bulgaria, 1680	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Multiprofile Hospital for Active Treatment Sveta Karidad \| Cardiology Department Plovdiv, Bulgaria, 4004	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Multiprofile Hospital for Active Treatment Medline Clinic Plovdiv, Bulgaria, 4000	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations MHAT Dr. Bratan Shukerov AD Smolyan, Bulgaria, 4700	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD \| Cardiology Department Sofia, Bulgaria, 1233	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Health Corporation of Galilee Medical Center Nahariya, Israel, 2210001	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Poriya Medical Center \| Nephrology and Hypertension Dept. Tiberius, Israel, 1528001	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Clalit Health Services Rabin Medical Center-Beilinson Campus Petah Tikva, Israel, 4941492	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Edith Wolfson Medical Center Holon, Israel, 5822012	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Lady Davis Carmel Medical Center Haifa, Israel, 3436212	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations IRCCS Centro Cardiologico Monzino S.p.A Milano, Italy, 20138	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Akademiska Sjukhuset Njurmottagningen Uppsala, Sweden, 751 85	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Odense Universitetshospital, Endokrinologisk Afd. M Odense C, Denmark, 5000	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Klinik Hietzing Wien, Austria, 1130	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Zentrum f. klinische Studien Dr. Hanusch GmbH Wien, Austria, 1060	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW) Bad Oeynhausen, Germany, 32545	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Kyiv City Center of Nephrology and Dialysis Kyiv, Ukraine, 02660	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Private enterprise private production company " Acinus" Kropyvnytskyi, Ukraine, 25006	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Dnepropetrovsk regional hospital n.a. I. I. Mechnikov Dnipro, Ukraine, 49005	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Ternopil Regional Clinical Hospital Ternopil, Ukraine, 46002	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Kyiv City Center of Nephrology and Dialysis Kyiv, Ukraine, 01023	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Medical Center of Edelweiss Medics LLC Kyiv, Ukraine, 02002	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Volyn Regional Clinical Hospital Lutsk, Ukraine, 43005	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional council Zaporizhzhya, Ukraine, 69600	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations FMC-dialyzacne sluzby, s.r.o. - Kosice Kosice, Slovakia, 04011	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations BIODIAL, spol. s r.o. Puchov, Slovakia, 02001	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Medivasa s.r.o. Zilina, Slovakia, 01001	Contact Us: E-mail: [email protected] Phone: +18888422937
Locations Medical center LLC " Fresenius medical care Ukraine» Cherkasy, Ukraine, 18009	Contact Us: E-mail: [email protected] Phone: +18888422937

Klinikum der Universität Würzburg

Wuerzburg, Germany, 97080

Contact Us:

Chronic Kidney Disease

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

EU CT Number:

Trial Purpose

Key Participation Requirements

sex

age

45 Years

No Limit

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information