Chymase inhibitor BAY 1142524 in patients with type II diabetes and a clinical diagnosis of diabetic kidney disease
- Conditions
- Type II diabetic mellitus (T2DM) patients with a clinical diagnosis of diabetic kidney disease (CKD)Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-000656-26-ES
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 107
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
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: 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: Last Visit of the Last Subject