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

Phase 2

Completed

• Conditions: Diabetic Kidney Disease
• Interventions: Drug: Fulacimstat (BAY1142524); Drug: Placebo

• Registration Number: NCT03412006
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-26
• Study Start: 2018-02-02
• Primary Completion: 2019-10-02
• Study Completion: 2019-10-10
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fulacimstat (BAY1142524)	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
Placebo	Placebo	Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition

Primary Outcome Measures

Name	Time	Method
Change in urinary albumin to creatinine ratio (UACR)	Baseline and at 6 months	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

Secondary Outcome Measures

Name	Time	Method
Number of patients with serious adverse events	From first intake of study drug up to 3 days after last administration of study drug
Number of patients with treatment-emergent adverse event	From first intake of study drug up to 3 days after last administration of study drug

Trial Locations

Locations (27)

Med. Center Equita; 🇧🇬 Varna, Bulgaria

TAYS TKI Keskus Tutkimusvastaanotto; 🇫🇮 Tampere, Finland

The Nazareth Trust Hospital EMMS; 🇮🇱 Nazareth, Israel

Shamir Medical Center (Assaf Harofeh); 🇮🇱 Zerifin, Israel

Med Centre Diamedical 2013; 🇧🇬 Dimitrovgrad, Bulgaria

Barzilai Medical Center; 🇮🇱 Ashkelon, Israel

Hadassah Hebrew University Hospital Ein Kerem; 🇮🇱 Jerusalem, Israel

A.O.U. di Padova; 🇮🇹 Padova, Veneto, Italy

MCOMH Preventsia-2000; 🇧🇬 Stara Zagora, Bulgaria

Pihlajalinna ITE Kuopio; 🇫🇮 Kuopio, Finland

Turun yliopistollinen keskussairaala, kantasairaala; 🇫🇮 Turku, Finland

DMC - Diabetes Medical Center; 🇮🇱 Tel Aviv, Israel

Nordsjællands Hospital; 🇩🇰 Hillerød, Denmark

Steno Diabetes Center Copenhagen; 🇩🇰 Gentofte, Denmark

Rigshospitalet; 🇩🇰 København, Denmark

Terveystalo Oulu; 🇫🇮 Oulu, Finland

Edith Wolfson Medical Center; 🇮🇱 Holon, Israel

A.O.U. Policlinico Federico II Napoli; 🇮🇹 Napoli, Campania, Italy

IRCCS Casa Sollievo della Sofferenza; 🇮🇹 Foggia, Puglia, Italy

Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim; 🇮🇹 Bologna, Emilia-Romagna, 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

S3 Clinical Research Centers; 🇸🇪 Vällingby, Sweden

Akardo MedSite AB; 🇸🇪 Stockholm, Sweden

Universitetssjukhuset Örebro; 🇸🇪 Örebro, Sweden