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

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
Status
LocationsStatus
Locations

Klinikum der Universität Würzburg

Wuerzburg, Germany, 97080

Status
Completed
 
Locations

DaVita Clinical Research Deutschland GmbH

Düsseldorf, Germany, 40210

Status
Completed
 
Locations

Medamed Studienambulanz GmbH

Leipzig, Germany, 04315

Status
Completed
 
Locations

InnoDiab Forschung GmbH

Essen, Germany, 45136

Status
Completed
 
Locations

Istituto Ricerche Farmacologiche Mario Negri IRCCS

Bergamo, Italy, 24020

Status
Completed
 
Locations

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

Bologna, Italy, 40138

Status
Completed
 
Locations

IRCCS Ospedale Policlinico San Martino

Genova, Italy, 16132

Status
Completed
 
Locations

A.O.U. Luigi Vanvitelli

Napoli, Italy, 80131

Status
Completed
 
Locations

Hospital Universitario Virgen de las Nieves

Granada, Spain, 18012

Status
Completed
 
Locations

Hospital Quirón

Barcelona, Spain, 08023

Status
Completed
 
Locations

Hospital del Mar

Barcelona, Spain, 08003

Status
Completed
 
Locations

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain, 15006

Status
Completed
 
Locations

Hospital Universitario Dr. Peset

Valencia, Spain, 46017

Status
Completed
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
 
Locations

Complexo Hospitalario Universitario de Ferrol

Ferrol, Spain, 15405

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

OL Vrouwziekenhuis - Campus Aalst

AALST, Belgium, 9300

Status
Completed
 
Locations

Ospedale San Raffaele s.r.l.

Milano, Italy, 20132

Status
Completed
 
Locations

Klinik Landstraße - Krankenhaus Rudolfstiftung

Wien, Austria, 1030

Status
Completed
 
Locations

Medizinische Universität Innsbruck

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Completed
 
Locations

Regionshospitalet Gødstrup

Herning, Denmark, 7400

Status
Completed
 
Locations

Aalborg Universitetshospital

Aalborg, Denmark, 9000

Status
Completed
 
Locations

Holbæk Sygehus

Holbæk, Denmark, 4300

Status
Completed
 
Locations

Kolding Sygehus

Kolding, Denmark, 6000

Status
Completed
 
Locations

Steno Diabetes Center Copenhagen

Gentofte, Denmark, 2730

Status
Completed
 
Locations

Turun yliopistollinen keskussairaala, kantasairaala

Turku, Finland, 20521

Status
Completed
 
Locations

Diagnos Klaukkalan Lääkäriasema

Klaukkala, Finland, 01800

Status
Completed
 
Locations

StudyCor Oy

Jyväskylä, Finland, 40620

Status
Completed
 
Locations

Omena Terveys Oy

Seinäjoki, Finland, 60320

Status
Completed
 
Locations

Barzilai Medical Center

Ashkelon, Israel, 7830604

Status
Completed
 
Locations

Chaim Sheba Medical Center

Ramat Gan, Israel, 5262000

Status
Completed
 
Locations

PTC-Primary care Trial Center

Göteborg, Sweden, 413 46

Status
Completed
 
Locations

Clemenstorget Hjärtmottagning

Lund, Sweden, 222 21

Status
Completed
 
Locations

ClinSmart

Uppsala, Sweden, 752 37

Status
Completed
 
Locations

Satucon / Kuopion Työterveys

Kuopio, Finland, 70100

Status
Completed
 
Locations

Centralny Szpital Kliniczny MSWiA w Warszawie

Warszawa, Poland, 02-507

Status
Completed
 
Locations

MCOMH Preventsia-2000

Stara Zagora, Bulgaria, 6000

Status
Completed
 
Locations

Med Centre Diamedical 2013

Dimitrovgrad, Bulgaria, 6400

Status
Completed
 
Locations

MC Kalimat

Sofia, Bulgaria, 1680

Status
Completed
 
Locations

MHAT Sveta Karidad

Plovdiv, Bulgaria, 4004

Status
Completed
 
Locations

Multiprofile Hospital for Active Treatment Medline Clinic

Plovdiv, Bulgaria, 4000

Status
Completed
 
Locations

MHAT Dr. Bratan Shukerov AD

Smolyan, Bulgaria, 4700

Status
Completed
 
Locations

MHAT "Knyaginya Klementina - Sofia"EAD

Sofia, Bulgaria, 1233

Status
Completed
 
Locations

Health Corporation of Galilee Medical Center

Nahariya, Israel, 2210001

Status
Completed
 
Locations

The Baruch Padeh Medical Center, Poriya

Tiberias, Israel, 1528001

Status
Completed
 
Locations

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel, 9112001

Status
Completed
 
Locations

Clalit Health Services Rabin Medical Center-Beilinson Campus

Petah Tikva, Israel, 4941492

Status
Completed
 
Locations

Edith Wolfson Medical Center

Holon, Israel, 5822012

Status
Completed
 
Locations

Lady Davis Carmel Medical Center

Haifa, Israel, 3436212

Status
Completed
 
Locations

IRCCS Centro Cardiologico Monzino S.p.A

Milano, Italy, 20138

Status
Completed
 
Locations

Akademiska Sjukhuset

Uppsala, Sweden, 751 85

Status
Completed
 
Locations

Odense Universitetshospital

Odense C, Denmark, DK-5000

Status
Completed
 
Locations

Klinik Hietzing

Wien, Austria, 1130

Status
Completed
 
Locations

Zentrum f. klinische Studien Dr. Hanusch GmbH

Wien, Austria, 1060

Status
Completed
 
Locations

Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)

Bad Oeynhausen, Germany, 32545

Status
Completed
 
Locations

Kyiv City Center of Nephrology and Dialysis

Kyiv, Ukraine, 02660

Status
Completed
 
Locations

Private enterprise private production company " Acinus"

Kropyvnytskyi, Ukraine, 25006

Status
Completed
 
Locations

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

Dnipro, Ukraine, 49005

Status
Completed
 
Locations

Ternopil University Hospital

Ternopil, Ukraine, 46002

Status
Completed
 
Locations

Kyiv City Center of Nephrology and Dialysis

Kyiv, Ukraine, 01023

Status
Completed
 
Locations

Medical Center of Edelweiss Medics LLC

Kyiv, Ukraine, 02002

Status
Completed
 
Locations

Volyn Regional Clinical Hospital

Lutsk, Ukraine, 43005

Status
Completed
 
Locations

Zaporizhzhia Regional Clinical Hospital

Zaporizhzhya, Ukraine, 69600

Status
Completed
 
Locations

FMC-dialyzacne sluzby, s.r.o.

Kosice, Slovakia, 040 11

Status
Completed
 
Locations

BIODIAL, spol. s r.o.

Puchov, Slovakia, 020 01

Status
Completed
 
Locations

Medivasa s.r.o.

Zilina, Slovakia, 01001

Status
Completed
 
Locations

Medical center LLC " Fresenius medical care Ukraine»

Cherkasy, Ukraine, 18009

Status
Completed
 

Trial Design