type II diabetic mellitus (T2DM) patients with a clinical diagnosis of diabetic kidney disease (CKD)
Conditions
Interventions
Product Name: BAY 1142524 25 mg Tablets
Product Code: BAY 1142524 25 mg Tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not assigned
CAS Number: not assigned
Current Sponsor code:
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): safety and tolerability;Timepoint(s) of evaluation of this end point: LVLS | — |
Countries
Bulgaria, Denmark, Finland, Israel, Italy, Spain, Sweden
Contacts
Public ContactBayer clinical Trails Contact
Bayer AG
Outcome results
None listed