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)

February 16, 2022 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Dimitrovgrad, Bulgaria, 6400
        • Med Centre Diamedical 2013
      • Stara Zagora, Bulgaria, 6000
        • MCOMH Preventsia-2000
      • Varna, Bulgaria, 9000
        • Med. Center Equita
  • Denmark
      • Gentofte, Denmark, 2730
        • Steno Diabetes Center Copenhagen
      • Hillerød, Denmark, 3400
        • Nordsjællands Hospital
      • København, Denmark, 2100
        • Rigshospitalet
  • Finland
      • Kuopio, Finland, 70100
        • Pihlajalinna ITE Kuopio
      • Oulu, Finland, FI-90100
        • Terveystalo Oulu
      • Tampere, Finland, 33520
        • TAYS TKI Keskus Tutkimusvastaanotto
      • Turku, Finland, FIN-20520
        • Turun yliopistollinen keskussairaala, kantasairaala
  • Israel
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center
      • Holon, Israel, 5822012
        • Edith Wolfson Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah Hebrew University Hospital Ein Kerem
      • Nazareth, Israel, 16100
        • The Nazareth Trust Hospital EMMS
      • Tel Aviv, Israel, 6937947
        • DMC - Diabetes Medical Center
      • Zerifin, Israel, 7030000
        • Shamir Medical Center (Assaf Harofeh)
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • A.O.U. Policlinico Federico II Napoli
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim
    • Puglia
      • Foggia, Puglia, Italy, 71013
        • IRCCS Casa Sollievo della Sofferenza
    • Veneto
      • Padova, Veneto, Italy, 35128
        • A.O.U. di Padova
  • Spain
      • Barcelona, Spain, 08025
        • Hospital Fundació Puigvert
    • A Coruña
      • Ferrol, A Coruña, Spain, 15405
        • Complexo Hospitalario Universitario de Ferrol
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Hospital de Galdakao
  • Sweden
      • Kristianstad, Sweden, 29185
        • Centralsjukhuset Kristianstad
      • Stockholm, Sweden, 114 46
        • Akardo MedSite AB
      • Vällingby, Sweden, 162 68
        • S3 Clinical Research Centers
      • Örebro, Sweden, 701 85
        • Universitetssjukhuset Örebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Fulacimstat (BAY1142524)
25 mg BAY1142524 are given twice daily over a treatment period of 6 months
Placebo Comparator: Placebo
Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition
Drug: Placebo
Matching placebo tablets are given twice daily over a treatment period of 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urinary albumin to creatinine ratio (UACR)
Time Frame: 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
Baseline and at 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2018

Primary Completion (Actual)

October 2, 2019

Study Completion (Actual)

October 10, 2019

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18933
  • 2017-000656-26 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Kidney Disease

Clinical Trials on Fulacimstat (BAY1142524)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe