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

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) who have finished their up-titration with an ARB or ACEI 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.
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 58

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
>160mmHg, diastolic blood pressure >100 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: Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events;Primary end point(s): Ratio of UACR at Visit 6 (167 ±14 days after Visit 1) to UACR at Visit 1;Timepoint(s) of evaluation of this end point: UACR will be assessed before the start of treatment with study drug (Visit 1) and after 6 months of treatment with study drug (Visit 6) for the primary variable.

Secondary Outcome Measures

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

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