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
CADA DIA
A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease
2 other identifiers
interventional
152
7 countries
27
Brief Summary
The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2018
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2018
CompletedFirst Posted
Study publicly available on registry
January 26, 2018
CompletedStudy Start
First participant enrolled
February 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2019
CompletedMarch 3, 2022
February 1, 2022
1.7 years
January 22, 2018
February 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in urinary albumin to creatinine ratio (UACR)
The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment
Baseline and at 6 months
Secondary Outcomes (2)
Number of patients with treatment-emergent adverse event
From first intake of study drug up to 3 days after last administration of study drug
Number of patients with serious adverse events
From first intake of study drug up to 3 days after last administration of study drug
Study Arms (2)
Fulacimstat (BAY1142524)
EXPERIMENTALPatients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition
Placebo
PLACEBO COMPARATORPatients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition
Interventions
25 mg BAY1142524 are given twice daily over a treatment period of 6 months
Matching placebo tablets are given twice daily over a treatment period of 6 months
Eligibility Criteria
You may qualify if:
- Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, without any adjustments to this therapy for at least 4 weeks prior to the screening visit.
- 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
You may not qualify if:
- Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (27)
Med Centre Diamedical 2013
Dimitrovgrad, 6400, Bulgaria
MCOMH Preventsia-2000
Stara Zagora, 6000, Bulgaria
Med. Center Equita
Varna, 9000, Bulgaria
Rigshospitalet
Copenhagen, 2100, Denmark
Steno Diabetes Center Copenhagen
Gentofte Municipality, 2730, Denmark
Nordsjællands Hospital
Hillerød, 3400, Denmark
Pihlajalinna ITE Kuopio
Kuopio, 70100, Finland
Terveystalo Oulu
Oulu, FI-90100, Finland
TAYS TKI Keskus Tutkimusvastaanotto
Tampere, 33520, Finland
Turun yliopistollinen keskussairaala, kantasairaala
Turku, FIN-20520, Finland
Barzilai Medical Center
Ashkelon, 7830604, Israel
Edith Wolfson Medical Center
Holon, 5822012, Israel
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, 9112001, Israel
The Nazareth Trust Hospital EMMS
Nazareth, 16100, Israel
DMC - Diabetes Medical Center
Tel Aviv, 6937947, Israel
Shamir Medical Center (Assaf Harofeh)
Ẕerifin, 7030000, Israel
IRCCS Casa Sollievo della Sofferenza
Foggia, Apulia, 71013, Italy
A.O.U. Policlinico Federico II Napoli
Napoli, Campania, 80131, Italy
Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim
Bologna, Emilia-Romagna, 40138, Italy
A.O.U. di Padova
Padua, Veneto, 35128, Italy
Complexo Hospitalario Universitario de Ferrol
Ferrol, A Coruña, 15405, Spain
Hospital de Galdakao
Galdakao, Vizcaya, 48960, Spain
Hospital Fundació Puigvert
Barcelona, 08025, Spain
Centralsjukhuset Kristianstad
Kristianstad, 29185, Sweden
Universitetssjukhuset Örebro
Örebro, 701 85, Sweden
Akardo MedSite AB
Stockholm, 114 46, Sweden
S3 Clinical Research Centers
Vällingby, 162 68, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2018
First Posted
January 26, 2018
Study Start
February 2, 2018
Primary Completion
October 2, 2019
Study Completion
October 10, 2019
Last Updated
March 3, 2022
Record last verified: 2022-02