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-BG
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 138
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) 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
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
>160 mmHg, or 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
- Secondary Outcome Measures
Name Time Method