check_circleStudy Completed

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.

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.

Key Participants Requirements

Sex

All

Age

45 - N/A

Trial summary

Enrollment Goal
243
Trial Dates
September 2020 - April 2022
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Runcaciguat (BAY1101042)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinikum der Universität WürzburgWuerzburg, 97080, Germany
Completed
DaVita Clinical Research Deutschland GmbHDuesseldorf, 40210, Germany
Completed
Medamed Studienambulanz GmbHLeipzig, 04315, Germany
Completed
InnoDiab Forschung GmbHEssen, 45136, Germany
Completed
Istituto Ricerche Farmacologiche Mario Negri IRCCSBergamo, 24020, Italy
Completed
A.O.U. di Bologna Policlinico S.Orsola MalpighiBologna, 40138, Italy
Completed
IRCCS Ospedale Policlinico San MartinoGenova, 16132, Italy
Completed
IRCCS Ospedale Policlinico San MartinoGenova, 16132, Italy
Completed
A.O.U. Luigi VanvitelliNapoli, 80131, Italy
Completed
Hospital Universitario Virgen de las Nieves|Medicina InternaGranada, 18014, Spain
Completed
Hospital Quironsalud Barcelona | Internal Medicine DepartmentBarcelona, 08023, Spain
Completed
Hospital del MarBarcelona, 08003, Spain
Completed
Complejo Hosp. Univ. A Coruña | Endocrinologia y NutricionA Coruña, 150006, Spain
Completed
Hospital Universitario Dr. PesetValencia, 46017, Spain
Completed
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Completed
Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión ArterialFerrol, 15405, Spain
Completed
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08023, Spain
Completed
UZ GentGENT, 9000, Belgium
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
Hôpital Erasme/Erasmus ZiekenhuisBRUXELLES - BRUSSEL, 1070, Belgium
Completed
OL Vrouwziekenhuis - Campus AalstAalst, 9300, Belgium
Completed
Ospedale San Raffaele s.r.l.Milano, 20132, Italy
Completed
Klinik Landstraße - Krankenhaus RudolfstiftungWien, 1030, Austria
Withdrawn
Uniklinikum Salzburg - LandeskrankenhausSalzburg, 5020, Austria
Withdrawn
Medizinische Universität GrazGraz, 3086, Austria
Completed
Medizinische Universität InnsbruckInnsbruck, 6020, Austria
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Regionshospitalet GødstrupHerning, 7400, Denmark
Completed
Region Nordjylland | Aalborg University Hospital - Cardiology DepartmentAalborg, 9000, Denmark
Completed
Region Nordjylland | Aalborg University Hospital - Cardiology DepartmentAalborg, 9000, Denmark
Completed
Holbæk SygehusHolbæk, 4300, Denmark
Completed
Sygehus Lillebaelt | Kolding Sygehus - Medicinske SygdommeKolding, 6000, Denmark
Completed
Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research DepartmentHerlev, 2730, Denmark
Completed
Turun yliopistollinen keskussairaalaTurku, 20521, Finland
Completed
Diagnos Klaukkalan LääkäriasemaKlaukkala, 01800, Finland
Completed
StudyCor OyJyväskylä, 40620, Finland
Completed
Omena Terveys OySeinäjoki, 60320, Finland
Completed
Barzilai Medical Center | Nephrology & Hypertension Dept.Ashkelon, 7830604, Israel
Completed
Chaim Sheba Medical CenterRamat Gan, 5262000, Israel
Completed
PTC-Primary care Trial CenterGöteborg, 413 46, Sweden
Completed
Clemenstorget HjärtmottagningLund, 222 21, Sweden
Completed
ClinSmartUppsala, 752 37, Sweden
Withdrawn
Avdelningen för kliniska prövningar AKPÖrebro, 703 62, Sweden
Completed
Satucon / Kuopion TyöterveysKuopio, 70100, Finland
Completed
Centralny Szpital Kliniczny MSWiA w WarszawieWarszawa, 02-507, Poland
Withdrawn
Uniwersyteckie Centrum Kliniczne Warszawskiego UMWarszawa, 02-097, Poland
Withdrawn
Miedzyleski Szpital SpecjalistycznyWarszawa, 04-749, Poland
Completed
MCOMH Preventsia-2000Stara Zagora, 6000, Bulgaria
Completed
Med Centre Diamedical 2013Dimitrovgrad, 6400, Bulgaria
Completed
MC KalimatSofia, 1680, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Sveta Karidad | Cardiology DepartmentPlovdiv, 4004, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Medline ClinicPlovdiv, 4000, Bulgaria
Completed
MHAT Dr. Bratan Shukerov ADSmolyan, 4700, Bulgaria
Withdrawn
MHAT Sveta AnnaSofia, 1872, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology DepartmentSofia, 1233, Bulgaria
Completed
Health Corporation of Galilee Medical CenterNahariya, 2210001, Israel
Completed
Poriya Medical Center | Nephrology and Hypertension Dept.Tiberius, 1528001, Israel
Completed
Hadassah Hebrew University Hospital Ein KeremJerusalem, 9112001, Israel
Completed
Clalit Health Services Rabin Medical Center-Beilinson CampusPetah Tikva, 4941492, Israel
Completed
Edith Wolfson Medical CenterHolon, 5822012, Israel
Completed
Lady Davis Carmel Medical CenterHaifa, 3436212, Israel
Completed
IRCCS Centro Cardiologico Monzino S.p.AMilano, 20138, Italy
Completed
Akademiska Sjukhuset NjurmottagningenUppsala, 751 85, Sweden
Completed
Odense Universitetshospital, Endokrinologisk Afd. MOdense C, 5000, Denmark
Completed
Klinik HietzingWien, 1130, Austria
Completed
Zentrum f. klinische Studien Dr. Hanusch GmbHWien, 1060, Austria
Completed
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)Bad Oeynhausen, 32545, Germany
Withdrawn
Medizinische Hochschule Hannover (MHH)Hannover, 30625, Germany
Withdrawn
B_Serwis Popenda Spólka JawnaChorzow, 41-500, Poland
Completed
Kyiv City Center of Nephrology and DialysisKyiv, 02660, Ukraine
Completed
Private enterprise private production company " Acinus"Kropyvnytskyi, 25006, Ukraine
Completed
Dnepropetrovsk regional hospital n.a. I. I. MechnikovDnipro, 49005, Ukraine
Completed
Ternopil Regional Clinical HospitalTernopil, 46002, Ukraine
Completed
Kyiv City Center of Nephrology and DialysisKyiv, 01023, Ukraine
Completed
Medical Center of Edelweiss Medics LLCKyiv, 02002, Ukraine
Completed
Volyn Regional Clinical HospitalLutsk, 43005, Ukraine
Completed
CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional councilZaporizhzhya, 69600, Ukraine
Completed
FMC-dialyzacne sluzby, s.r.o. - KosiceKosice, 04011, Slovakia
Withdrawn
FMC-dialyzacne sluzby, s.r.o. - BratislavaBratislava, 851 07, Slovakia
Completed
BIODIAL, spol. s r.o.Puchov, 02001, Slovakia
Completed
Medivasa s.r.o.Zilina, 01001, Slovakia
Completed
Medical center LLC " Fresenius medical care Ukraine»Cherkasy, 18009, Ukraine

Primary Outcome

  • Mean change in urinary albumin-to-creatinine ratio (UACR) from baseline to the average of multiple time points during treatment
    date_rangeTime Frame:
    From baseline up to day 57 (± 3)

Secondary Outcome

  • Number of subjects with treatment emergent adverse event (TEAE)
    date_rangeTime Frame:
    From first treatment administration up to end of follow up (Day 87±7)
  • Number of subjects with early discontinuations
    date_rangeTime Frame:
    From first treatment administration up to end of treatment (Day 57±3)

Trial design

A randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of individually titrated oral doses of runcaciguat in subjects with clinical diagnosis of chronic kidney disease with diabetes and/or hypertension and at least one cardiovascular comorbidity
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2