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.

PHASE2CompletedINTERVENTIONAL
Enrollment

243

Participants

Timeline

Start Date

September 1, 2020

Primary Completion Date

March 8, 2022

Study Completion Date

April 5, 2022

Conditions
Chronic Kidney Disease
Interventions
DRUG

runcaciguat

Titrated dose of active dose 1, dose 2, dose 3, dose 4 of runcaciguat will be administered orally once a day.

OTHER

Placebo

Sham-titrated dose of matching placebo will be administered orally once a day.

Trial Locations (71)

1030

Klinik Landstraße - Krankenhaus Rudolfstiftung, Vienna

1060

Zentrum f. klinische Studien Dr. Hanusch GmbH, Vienna

1070

Hôpital Erasme/Erasmus Ziekenhuis, Bruxelles - Brussel

1090

Universitätsklinikum AKH Wien, Vienna

1130

Klinik Hietzing, Vienna

1233

"MHAT Knyaginya Klementina - SofiaEAD", Sofia

1680

MC Kalimat, Sofia

2730

Steno Diabetes Center Copenhagen, Herlev

3000

UZ Leuven Gasthuisberg, Leuven

4000

Multiprofile Hospital for Active Treatment Medline Clinic, Plovdiv

4004

MHAT Sveta Karidad, Plovdiv

4300

Holbæk Sygehus, Holbæk

4700

MHAT Dr. Bratan Shukerov AD, Smolyan

5000

Odense Universitetshospital, Endokrinologisk Afd. M, Odense C

6000

MCOMH Preventsia-2000, Stara Zagora

6020

Medizinische Universität Innsbruck, Innsbruck

6400

Med Centre Diamedical 2013, Dimitrovgrad

7400

Regionshospitalet Gødstrup, Herning

9000

UZ Gent, Ghent

9300

OL Vrouwziekenhuis - Campus Aalst, Aalst

16132

IRCCS Ospedale Policlinico San Martino, Genoa

18009

"Medical center LLC Fresenius medical care Ukraine", Cherkasy

20132

Ospedale San Raffaele s.r.l., Milan

20138

IRCCS Centro Cardiologico Monzino S.p.A, Milan

20521

Turun yliopistollinen keskussairaala, Turku

24020

Istituto Ricerche Farmacologiche Mario Negri IRCCS, Bergamo

25006

"Private enterprise private production company Acinus", Kropyvnytskyi

32545

Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW), Bad Oeynhausen

40138

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

40210

DaVita Clinical Research Deutschland GmbH, Düsseldorf

40620

StudyCor Oy, Jyväskylä

43005

Volyn Regional Clinical Hospital, Lutsk

45136

InnoDiab Forschung GmbH, Essen

46002

Ternopil Regional Clinical Hospital, Ternopil

46010

Hospital Clínico Universitario de Valencia, Valencia

46017

Hospital Universitario Dr. Peset, Valencia

49005

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

60320

Omena Terveys Oy, Seinäjoki

69600

Zaporizhzhia Regional Clinical Hospital, Zaporizhzhya

70100

Satucon / Kuopion Työterveys, Kuopio

80131

A.O.U. Luigi Vanvitelli, Napoli

97080

Klinikum der Universität Würzburg, Würzburg

2210001

Health Corporation of Galilee Medical Center, Nahariya

3436212

Lady Davis Carmel Medical Center, Haifa

4941492

Clalit Health Services Rabin Medical Center-Beilinson Campus, Petah Tikva

5262000

Chaim Sheba Medical Center, Ramat Gan

5822012

Edith Wolfson Medical Center, Holon

9112001

Hadassah Hebrew University Hospital Ein Kerem, Jerusalem

Unknown

"Region Nordjylland , Aalborg University Hospital - Cardiology Department"

"Sygehus Lillebaelt , Kolding Sygehus - Medicinske Sygdomme"

"Barzilai Medical Center , Nephrology & Hypertension Dept."

"Poriya Medical Center , Nephrology and Hypertension Dept."

"Complejo Hosp. Univ. A Coruña , Endocrinologia y Nutricion"

"Hospital Universitario Virgen de las Nieves, Medicina Interna"

01800

Diagnos Klaukkalan Lääkäriasema, Klaukkala

04315

Medamed Studienambulanz GmbH, Leipzig

02-507

Centralny Szpital Kliniczny MSWiA w Warszawie, Warsaw

040 11

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

020 01

BIODIAL, spol. s r.o., Púchov

01001

Medivasa s.r.o., Žilina

A Coruña

"Complejo Hospitalario Universitario de Ferrol , Hospital Naval - Unidad de Hipertensión Arterial"

08003

Hospital del Mar, Barcelona

08023

Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona

Hospital Quirón, Barcelona

413 46

PTC-Primary care Trial Center, Gothenburg

222 21

Clemenstorget Hjärtmottagning, Lund

751 85

Akademiska Sjukhuset Njurmottagningen, Uppsala

752 37

ClinSmart, Uppsala

01023

Kyiv City Center of Nephrology and Dialysis, Kyiv

02002

Medical Center of Edelweiss Medics LLC, Kyiv

02660

Kyiv City Center of Nephrology and Dialysis, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY