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AzTrials

Chronic Kidney DiseasePhase 2CONCORDNCT04507061

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.

A Phase 2 study testing runcaciguat in people with Chronic Kidney Disease, run by Bayer at 71 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Chronic Kidney Disease
What is being tested?
runcaciguat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
243 participants
Where
71 sitesin 13 countries
Study dates
1 Sep 2020to 5 Apr 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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:
  • History of active inflammatory bowel disease within the last 6 months before randomization;
  • Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
  • Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last 6 months before randomization;
  • 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 locations and contacts

71 sites in 13 countries.

71 sites in 13 countries

Ukraine9 sites

  • Medical center LLC " Fresenius medical care Ukraine"

    Cherkasy, 18009

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

    Dnipro, 49005

  • Private enterprise private production company " Acinus"

    Kropyvnytskyi, 25006

  • Kyiv City Center of Nephrology and Dialysis

    Kyiv, 01023

  • Medical Center of Edelweiss Medics LLC

    Kyiv, 02002

  • Kyiv City Center of Nephrology and Dialysis

    Kyiv, 02660

  • Volyn Regional Clinical Hospital

    Lutsk, 43005

  • Ternopil Regional Clinical Hospital

    Ternopil, 46002

  • Zaporizhzhia Regional Clinical Hospital

    Zaporizhzhya, 69600

Other trials in Ukraine

Israel8 sites

  • Barzilai Medical Center | Nephrology & Hypertension Dept.

    Ashkelon, 7830604

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Edith Wolfson Medical Center

    Holon, 5822012

  • Hadassah Hebrew University Hospital Ein Kerem

    Jerusalem, 9112001

  • Health Corporation of Galilee Medical Center

    Nahariya, 2210001

  • Clalit Health Services Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 5262000

  • Poriya Medical Center | Nephrology and Hypertension Dept.

    Tiberius, 1528001

Other trials in Israel

Spain8 sites

  • Complejo Hosp. Univ. A Coruña | Endocrinologia y Nutricion

    A Coruña, 150006

  • Hospital del Mar

    Barcelona, 08003

  • Ciutat Sanitaria i Universitaria de la Vall d'Hebron

    Barcelona, 08023

  • Hospital Quirón

    Barcelona, 08023

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

    Ferrol, A Coruña, 15405

  • Hospital Universitario Virgen de las Nieves|Medicina Interna

    Granada, 18014

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Dr. Peset

    Valencia, 46017

Other trials in Spain

Bulgaria7 sites

  • Med Centre Diamedical 2013

    Dimitrovgrad, 6400

  • Multiprofile Hospital for Active Treatment Medline Clinic

    Plovdiv, 4000

  • MHAT Sveta Karidad

    Plovdiv, 4004

  • MHAT Dr. Bratan Shukerov AD

    Smolyan, 4700

  • MHAT "Knyaginya Klementina - Sofia"EAD

    Sofia, 1233

  • MC Kalimat

    Sofia, 1680

  • MCOMH Preventsia-2000

    Stara Zagora, 6000

Other trials in Bulgaria

Denmark6 sites

  • Region Nordjylland | Aalborg University Hospital - Cardiology Department

    Aalborg, 9000

  • Steno Diabetes Center Copenhagen

    Herlev, 2730

  • Regionshospitalet Gødstrup

    Herning, 7400

  • Holbæk Sygehus

    Holbæk, 4300

  • Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme

    Kolding, 6000

  • Odense Universitetshospital, Endokrinologisk Afd. M

    Odense C, 5000

Other trials in Denmark

Italy6 sites

  • Istituto Ricerche Farmacologiche Mario Negri IRCCS

    Bergamo, Lombardy, 24020

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

    Bologna, Emilia-Romagna, 40138

  • IRCCS Ospedale Policlinico San Martino

    Genoa, Liguria, 16132

  • Ospedale San Raffaele s.r.l.

    Milan, Lombardy, 20132

  • IRCCS Centro Cardiologico Monzino S.p.A

    Milan, Lombardy, 20138

  • A.O.U. Luigi Vanvitelli

    Naples, Campania, 80131

Other trials in Italy

Austria5 sites

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

  • Klinik Landstraße - Krankenhaus Rudolfstiftung

    Vienna, 1030

  • Zentrum f. klinische Studien Dr. Hanusch GmbH

    Vienna, 1060

  • Universitätsklinikum AKH Wien

    Vienna, 1090

  • Klinik Hietzing

    Vienna, 1130

Other trials in Austria

Finland5 sites

  • StudyCor Oy

    Jyväskylä, 40620

  • Diagnos Klaukkalan Lääkäriasema

    Klaukkala, 01800

  • Satucon / Kuopion Työterveys

    Kuopio, 70100

  • Omena Terveys Oy

    Seinäjoki, 60320

  • Turun yliopistollinen keskussairaala

    Turku, 20521

Other trials in Finland

Germany5 sites

  • Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • DaVita Clinical Research Deutschland GmbH

    Düsseldorf, North Rhine-Westphalia, 40210

  • InnoDiab Forschung GmbH

    Essen, North Rhine-Westphalia, 45136

  • Medamed Studienambulanz GmbH

    Leipzig, Saxony, 04315

  • Klinikum der Universität Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

Belgium4 sites

  • OL Vrouwziekenhuis - Campus Aalst

    Aalst, 9300

  • Hôpital Erasme/Erasmus Ziekenhuis

    Bruxelles - Brussel, 1070

  • UZ Gent

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Sweden4 sites

  • PTC-Primary care Trial Center

    Gothenburg, 413 46

  • Clemenstorget Hjärtmottagning

    Lund, 222 21

  • Akademiska Sjukhuset Njurmottagningen

    Uppsala, 751 85

  • ClinSmart

    Uppsala, 752 37

Other trials in Sweden

Slovakia3 sites

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

    Košice, 040 11

  • BIODIAL, spol. s r.o.

    Púchov, 020 01

  • Medivasa s.r.o.

    Žilina, 01001

Other trials in Slovakia

Poland1 site

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, 02-507

Other trials in Poland

About this study

Official title: 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

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.

Being tested
runcaciguat, Placebo
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • runcaciguatDrug

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

  • PlaceboOther

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

Study groups in NCT04507061
Study groupRoleWhat they receive
runcaciguatExperimentalParticipant randomized to this arm will be up-titrated. A 30-day safety follow up will be performed after end of treatment or after early discontinuation from the study.
Receives: Drug: runcaciguat
PlaceboPlacebo comparatorParticipant randomized to this arm will be sham-titrated. A 30-day safety follow up will be performed after end of treatment or after early discontinuation from the study.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in urinary albumin-to-creatinine ratio (UACR) from baseline to the average of multiple time points during treatment

    Measured: From baseline up to day 57 (± 3)

Secondary outcomes (2)

  1. Number of subjects with treatment emergent adverse event (TEAE)

    Measured: From first treatment administration up to end of follow up (Day 87±7)

  2. Number of subjects with early discontinuations

    Measured: From first treatment administration up to end of treatment (Day 57±3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2020
  2. Study start1 Sep 2020
  3. Primary completion8 Mar 2022
  4. Study completion5 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04507061
Sponsor's protocol ID
18748
Other IDs
2019-003297-53, 2019
Acronym
CONCORD
Status last verified
Mar 2023
First submitted
6 Aug 2020
Last updated
4 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

  • Gansevoort RT, Wheeler DC, Deben FM, Speeckaert M, Thomas D, Berger M, Klein S, Friedrichs F, Paraschin K, Schmieder RE. The soluble guanylate cyclase activator runcaciguat significantly improves albuminuria in patients with chronic kidney disease: a randomized placebo-controlled clinical trial. Nephrol Dial Transplant. 2025 May 30;40(6):1147-1160. doi: 10.1093/ndt/gfae261.

    PubMed 39656628

  • Kraehling JR, Benardeau A, Schomber T, Popp L, Vienenkoetter J, Ellinger-Ziegelbauer H, Pavkovic M, Hartmann E, Siudak K, Freyberger A, Hagelschuer I, Mathar I, Hueser J, Hahn MG, Geiss V, Eitner F, Sandner P. The sGC Activator Runcaciguat Has Kidney Protective Effects and Prevents a Decline of Kidney Function in ZSF1 Rats. Int J Mol Sci. 2023 Aug 25;24(17):13226. doi: 10.3390/ijms241713226.

    PubMed 37686032

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing runcaciguat in people with Chronic Kidney Disease, run by Bayer at 71 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in Ukraine, Israel, Spain, Bulgaria, Denmark and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in urinary albumin-to-creatinine ratio (UACR) from baseline to the average of multiple time points during treatment (time frame: From baseline up to day 57 (± 3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04507061, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.

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