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

Diabetic Kidney Disease Clinical Trial

— CADA DIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412006
• Other study ID #: 18933
• Secondary ID: 2017-000656-26
• Status: Completed
• Phase: Phase 2
• Start date: February 2, 2018
• Est. completion date: October 10, 2019

Study information

• Verified date: February 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: October 10, 2019
• Est. primary completion date: October 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Bulgaria	Med Centre Diamedical 2013	Dimitrovgrad
Bulgaria	MCOMH Preventsia-2000	Stara Zagora
Bulgaria	Med. Center Equita	Varna
Denmark	Steno Diabetes Center Copenhagen	Gentofte
Denmark	Nordsjællands Hospital	Hillerød
Denmark	Rigshospitalet	København
Finland	Pihlajalinna ITE Kuopio	Kuopio
Finland	Terveystalo Oulu	Oulu
Finland	TAYS TKI Keskus Tutkimusvastaanotto	Tampere
Finland	Turun yliopistollinen keskussairaala, kantasairaala	Turku
Israel	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)	Zerifin
Italy	Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim	Bologna	Emilia-Romagna
Italy	IRCCS Casa Sollievo della Sofferenza	Foggia	Puglia
Italy	A.O.U. Policlinico Federico II Napoli	Napoli	Campania
Italy	A.O.U. di Padova	Padova	Veneto
Spain	Hospital Fundació Puigvert	Barcelona
Spain	Complexo Hospitalario Universitario de Ferrol	Ferrol	A Coruña
Spain	Hospital de Galdakao	Galdakao	Vizcaya
Sweden	Centralsjukhuset Kristianstad	Kristianstad
Sweden	Universitetssjukhuset Örebro	Örebro
Sweden	Akardo MedSite AB	Stockholm
Sweden	S3 Clinical Research Centers	Vällingby

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Bulgaria,  Denmark,  Finland,  Israel,  Italy,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with treatment-emergent adverse event		From first intake of study drug up to 3 days after last administration of study drug
Secondary	Number of patients with serious adverse events		From first intake of study drug up to 3 days after last administration of study drug

External Links

•   Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
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