search
Back to results

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)

Primary Purpose

Diabetic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fulacimstat (BAY1142524)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease focused on measuring type II diabetes, diabetic kidney disease

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Med Centre Diamedical 2013
  • MCOMH Preventsia-2000
  • Med. Center Equita
  • Steno Diabetes Center Copenhagen
  • Nordsjællands Hospital
  • Rigshospitalet
  • Pihlajalinna ITE Kuopio
  • Terveystalo Oulu
  • TAYS TKI Keskus Tutkimusvastaanotto
  • Turun yliopistollinen keskussairaala, kantasairaala
  • Barzilai Medical Center
  • Edith Wolfson Medical Center
  • Hadassah Hebrew University Hospital Ein Kerem
  • The Nazareth Trust Hospital EMMS
  • DMC - Diabetes Medical Center
  • Shamir Medical Center (Assaf Harofeh)
  • A.O.U. Policlinico Federico II Napoli
  • Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim
  • IRCCS Casa Sollievo della Sofferenza
  • A.O.U. di Padova
  • Complexo Hospitalario Universitario de Ferrol
  • Hospital de Galdakao
  • Hospital Fundació Puigvert
  • Centralsjukhuset Kristianstad
  • Akardo MedSite AB
  • S3 Clinical Research Centers
  • Universitetssjukhuset Örebro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fulacimstat (BAY1142524)

Placebo

Arm Description

Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition

Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients with treatment-emergent adverse event
Number of patients with serious adverse events

Full Information

First Posted
January 22, 2018
Last Updated
February 16, 2022
Sponsor
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT03412006
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
October 2, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease
Keywords
type II diabetes, diabetic kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fulacimstat (BAY1142524)
Arm Type
Experimental
Arm Description
Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition
Intervention Type
Drug
Intervention Name(s)
Fulacimstat (BAY1142524)
Intervention Description
25 mg BAY1142524 are given twice daily over a treatment period of 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets are given twice daily over a treatment period of 6 months
Primary Outcome Measure Information:
Title
Change in urinary albumin to creatinine ratio (UACR)
Description
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
Time Frame
Baseline and at 6 months
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Med Centre Diamedical 2013
City
Dimitrovgrad
ZIP/Postal Code
6400
Country
Bulgaria
Facility Name
MCOMH Preventsia-2000
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Med. Center Equita
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Steno Diabetes Center Copenhagen
City
Gentofte
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Nordsjællands Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Rigshospitalet
City
København
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Pihlajalinna ITE Kuopio
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Terveystalo Oulu
City
Oulu
ZIP/Postal Code
FI-90100
Country
Finland
Facility Name
TAYS TKI Keskus Tutkimusvastaanotto
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Turun yliopistollinen keskussairaala, kantasairaala
City
Turku
ZIP/Postal Code
FIN-20520
Country
Finland
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Hadassah Hebrew University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
The Nazareth Trust Hospital EMMS
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
DMC - Diabetes Medical Center
City
Tel Aviv
ZIP/Postal Code
6937947
Country
Israel
Facility Name
Shamir Medical Center (Assaf Harofeh)
City
Zerifin
ZIP/Postal Code
7030000
Country
Israel
Facility Name
A.O.U. Policlinico Federico II Napoli
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
IRCCS Casa Sollievo della Sofferenza
City
Foggia
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
A.O.U. di Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Complexo Hospitalario Universitario de Ferrol
City
Ferrol
State/Province
A Coruña
ZIP/Postal Code
15405
Country
Spain
Facility Name
Hospital de Galdakao
City
Galdakao
State/Province
Vizcaya
ZIP/Postal Code
48960
Country
Spain
Facility Name
Hospital Fundació Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Centralsjukhuset Kristianstad
City
Kristianstad
ZIP/Postal Code
29185
Country
Sweden
Facility Name
Akardo MedSite AB
City
Stockholm
ZIP/Postal Code
114 46
Country
Sweden
Facility Name
S3 Clinical Research Centers
City
Vällingby
ZIP/Postal Code
162 68
Country
Sweden
Facility Name
Universitetssjukhuset Örebro
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer Healthcare products.

Learn more about this trial

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

We'll reach out to this number within 24 hrs