Chymase inhibitor BAY 1142524 in patients with type II diabetes and a clinical diagnosis of diabetic kidney disease

Phase 1

Conditions: type II diabetic mellitus (T2DM) patients with a clinical diagnosis of diabetic kidney disease (CKD)
MedDRA version: 21.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2017-000656-26-IT

Lead Sponsor: BAYER AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 147

Inclusion Criteria

1. Patients with T2DM and a clinical diagnosis of DKD (as judged by the investigator) treated with at least the minimal recommended dose of an ARB or an ACEI (according to international or local guidelines) – but not with both simultaneously – for at least 3 months prior to the screening visit without any adjustments to this therapy for at least 4 weeks prior to the screening visit
2. UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit
3. eGFR =30 mL/min/1.73 m2 and <90 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion Criteria

1. Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator
2. Known bilateral clinical relevant renal artery stenosis (>75%)
3. New York Heart Association (NYHA) Class IV
4. Acute kidney injury or dialysis within the last 3 months before the screening visit
5. Renal replacement therapy during study conduct
6. Renal allograft in place or a scheduled kidney transplant during study conduct
7. Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit
8. Clinically relevant hepatic dysfunction
9. Uncontrolled hypertension as evidenced by systolic blood pressure
>180 mmHg, diastolic blood pressure >110 mmHg (mean of triplicate values at the screening or baseline visit after at least 10 minutes rest in sitting position

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate the change in UACR from baseline values obtained at Visit 1 to 6 months after treatment with BAY 1142524, in comparison to placebo, on top of standard of care therapy.;Secondary Objective: assess safety and tolerability as evidenced by the incidence and severity of adverse events;Primary end point(s): The primary variable will be the ratio of UACR at Visit 6 (167 ±14 days after Visit 1) to UACR at Visit 1 (Day 0, before start of treatment with study drug).;Timepoint(s) of evaluation of this end point: Per la variabile primaria, l’UACR verrà valutato prima dell’inizio del trattamento con il farmaco in studio (Visita 1) e dopo 6 mesi di trattamento con il farmaco in studio (Visita 6).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): safety and tolerability<br>;Timepoint(s) of evaluation of this end point: LVLS

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