check_circleStudy Completed

Diabetic kidney disease

Bayer Identifier:

18933

ClinicalTrials.gov Identifier:

NCT03412006

EudraCT Number:

2017-000656-26

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

All

Age

18 - 79 Years
  • - 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

  • - 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
February 2018 - October 2019
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Fulacimstat (BAY1142524)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
S3 Clinical Research CentersVällingby, 162 68, Sweden
Completed
Steno Diabetes Center CopenhagenGentofte, 2730, Denmark
Completed
RigshospitaletKøbenhavn, 2100, Denmark
Completed
Nordsjællands HospitalHillerød, 3400, Denmark
Completed
Med Centre Diamedical 2013Dimitrovgrad, 6400, Bulgaria
Completed
Med. Center EquitaVarna, 9000, Bulgaria
Completed
MCOMH Preventsia-2000Stara Zagora, 6000, Bulgaria
Completed
Terveystalo OuluOulu, FI-90100, Finland
Completed
Turun yliopistollinen keskussairaala, kantasairaalaTurku, FIN-20520, Finland
Completed
TAYS TKI Keskus TutkimusvastaanottoTampere, 33520, Finland
Completed
Barzilai Medical CenterAshkelon, 7830604, Israel
Completed
Edith Wolfson Medical CenterHolon, 5822012, Israel
Completed
A.O.U. di PadovaPadova, 35128, Italy
Completed
IRCCS Casa Sollievo della SofferenzaFoggia, 71013, Italy
Completed
A.O.U. Policlinico Federico II NapoliNapoli, 80131, Italy
Completed
Complexo Hospitalario Universitario de FerrolFerrol, 15405, Spain
Completed
Hospital de GaldakaoGaldakao, 48960, Spain
Completed
Hospital Fundació PuigvertBarcelona, 08025, Spain
Completed
Centralsjukhuset KristianstadKristianstad, 29185, Sweden
Completed
Universitetssjukhuset ÖrebroÖrebro, 701 85, Sweden
Completed
Akardo MedSite ABStockholm, 114 46, Sweden
Completed
DMC - Diabetes Medical CenterTel Aviv, 6937947, Israel
Completed
Hadassah Hebrew University Hospital Ein KeremJerusalem, 9112001, Israel
Completed
The Nazareth Trust Hospital EMMSNazareth, 16100, Israel
Completed
Shamir Medical Center (Assaf Harofeh)Zerifin, 7030000, Israel
Completed
Pihlajalinna ITE KuopioKuopio, 70100, Finland
Completed
Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e SperimBologna, 40138, Italy
Withdrawn
ASL Napoli 1 CentroNapoli, 80138, Italy

Primary Outcome

  • 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
    date_rangeTime Frame:
    Baseline and at 6 months

Secondary Outcome

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

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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