Trial Condition(s):

Diabetic Kidney Disease

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)

Bayer Identifier:

18933

ClinicalTrials.gov Identifier:

NCT03412006

EudraCT Number:

2017-000656-26

Study Completed

Trial Purpose

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.

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)

Trial Summary

Enrollment Goal
152
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Fulacimstat (BAY1142524)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

S3 Clinical Research Centers

Vällingby, Sweden, 162 68

Status
Completed
 
Locations

Steno Diabetes Center Copenhagen

Gentofte, Denmark, 2730

Status
Completed
 
Locations

Rigshospitalet

København, Denmark, 2100

Status
Completed
 
Locations

Nordsjællands Hospital

Hillerød, Denmark, 3400

Status
Completed
 
Locations

Med Centre Diamedical 2013

Dimitrovgrad, Bulgaria, 6400

Status
Completed
 
Locations

Med. Center Equita

Varna, Bulgaria, 9000

Status
Completed
 
Locations

MCOMH Preventsia-2000

Stara Zagora, Bulgaria, 6000

Status
Completed
 
Locations

Terveystalo Oulu

Oulu, Finland, FI-90100

Status
Completed
 
Locations

Turun yliopistollinen keskussairaala, kantasairaala

Turku, Finland, FIN-20520

Status
Completed
 
Locations

TAYS TKI Keskus Tutkimusvastaanotto

Tampere, Finland, 33520

Status
Completed
 
Locations

Barzilai Medical Center

Ashkelon, Israel, 7830604

Status
Completed
 
Locations

Edith Wolfson Medical Center

Holon, Israel, 5822012

Status
Completed
 
Locations

A.O.U. di Padova

Padova, Italy, 35128

Status
Completed
 
Locations

IRCCS Casa Sollievo della Sofferenza

Foggia, Italy, 71013

Status
Completed
 
Locations

A.O.U. Policlinico Federico II Napoli

Napoli, Italy, 80131

Status
Completed
 
Locations

Complexo Hospitalario Universitario de Ferrol

Ferrol, Spain, 15405

Status
Completed
 
Locations

Hospital de Galdakao

Galdakao, Spain, 48960

Status
Completed
 
Locations

Hospital Fundació Puigvert

Barcelona, Spain, 08025

Status
Completed
 
Locations

Centralsjukhuset Kristianstad

Kristianstad, Sweden, 29185

Status
Completed
 
Locations

Universitetssjukhuset Örebro

Örebro, Sweden, 701 85

Status
Completed
 
Locations

Akardo MedSite AB

Stockholm, Sweden, 114 46

Status
Completed
 
Locations

DMC - Diabetes Medical Center

Tel Aviv, Israel, 6937947

Status
Completed
 
Locations

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel, 9112001

Status
Completed
 
Locations

The Nazareth Trust Hospital EMMS

Nazareth, Israel, 16100

Status
Completed
 
Locations

Shamir Medical Center (Assaf Harofeh)

Zerifin, Israel, 7030000

Status
Completed
 
Locations

Pihlajalinna ITE Kuopio

Kuopio, Finland, 70100

Status
Completed
 
Locations

Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim

Bologna, Italy, 40138

Status
Completed
 

Trial Design