A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease
NCT ID: NCT03412006
Last Updated: 2022-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
152 participants
INTERVENTIONAL
2018-02-02
2019-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fulacimstat (BAY1142524)
Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition
Fulacimstat (BAY1142524)
25 mg BAY1142524 are given twice daily over a treatment period of 6 months
Placebo
Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition
Placebo
Matching placebo tablets are given twice daily over a treatment period of 6 months
Interventions
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Fulacimstat (BAY1142524)
25 mg BAY1142524 are given twice daily over a treatment period of 6 months
Placebo
Matching placebo tablets are given twice daily over a treatment period of 6 months
Eligibility Criteria
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Inclusion Criteria
* UACR \>50 mg/g and \<3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit
* estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m\*2 and \<90 mL/min/1.73 m\*2 (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) at the screening visit and the baseline visit
Exclusion Criteria
* Known bilateral clinical relevant renal artery stenosis (\>75%)
* New York Heart Association (NYHA) Class IV
* Acute kidney injury or dialysis within the last 3 months before the screening visit
* Renal replacement therapy during study conduct
* Renal allograft in place or a scheduled kidney transplant during study conduct
* Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit
* Clinically relevant hepatic dysfunction
* Uncontrolled hypertension as evidenced by systolic blood pressure \>160 mmHg, diastolic blood pressure \>100 mmHg (mean of triplicate values at the screening or baseline visit)
18 Years
79 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Med Centre Diamedical 2013
Dimitrovgrad, , Bulgaria
MCOMH Preventsia-2000
Stara Zagora, , Bulgaria
Med. Center Equita
Varna, , Bulgaria
Rigshospitalet
Copenhagen, , Denmark
Steno Diabetes Center Copenhagen
Gentofte Municipality, , Denmark
Nordsjællands Hospital
Hillerød, , Denmark
Pihlajalinna ITE Kuopio
Kuopio, , Finland
Terveystalo Oulu
Oulu, , Finland
TAYS TKI Keskus Tutkimusvastaanotto
Tampere, , Finland
Turun yliopistollinen keskussairaala, kantasairaala
Turku, , Finland
Barzilai Medical Center
Ashkelon, , Israel
Edith Wolfson Medical Center
Holon, , Israel
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, , Israel
The Nazareth Trust Hospital EMMS
Nazareth, , Israel
DMC - Diabetes Medical Center
Tel Aviv, , Israel
Shamir Medical Center (Assaf Harofeh)
Ẕerifin, , Israel
IRCCS Casa Sollievo della Sofferenza
Foggia, Apulia, Italy
A.O.U. Policlinico Federico II Napoli
Napoli, Campania, Italy
Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim
Bologna, Emilia-Romagna, Italy
A.O.U. di Padova
Padua, Veneto, Italy
Complexo Hospitalario Universitario de Ferrol
Ferrol, A Coruña, Spain
Hospital de Galdakao
Galdakao, Vizcaya, Spain
Hospital Fundació Puigvert
Barcelona, , Spain
Centralsjukhuset Kristianstad
Kristianstad, , Sweden
Universitetssjukhuset Örebro
Örebro, , Sweden
Akardo MedSite AB
Stockholm, , Sweden
S3 Clinical Research Centers
Vällingby, , Sweden
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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2017-000656-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
18933
Identifier Type: -
Identifier Source: org_study_id
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