Safety and efficacy of different oral doses of BAY 94-8862 in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic nephropathy

Phase 1

Active, not recruiting

• Conditions: Diabetic nephropathy; MedDRA version: 16.1 Level: PT Classification code 10061835 Term: Diabetic nephropathy System Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-004179-38-NL
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-02
• Study Completion: 2014-08-07
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 823

Inclusion Criteria

Men and women aged 18 years and older.
Subjects with type 2 diabetes mellitus
Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:
- Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of >/=300 mg/g in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m2 (CKD-EPI) or
- Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g in 2 out of 3 first morning void samples and eGFR >/=30 mL/min/1.73 m2 (CKD-EPI)
Subjects with at least the minimal dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), but not both, for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit; subjects with an eGFR of 30-45 mL/min/1.73 m2 (CKD-EPI) must also be treated with a non-potassium sparing diuretic at the screening visit and without any adjustments to this therapy for at least 4 weeks prior to the screening visit
- Serum potassium
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 670
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 670

Exclusion Criteria

Non-diabetic renal disease (confirmed by biopsy)
Known bilateral clinically relevant renal artery stenosis (>75%)
Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean sitting SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit
Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the run-in visit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective of the study is to investigate the change of urinary albumin-to-creatinine ratio (UACR) after treatment with different oral doses of BAY 94 8862 given once daily over 90 days;<br> Secondary Objective: Change in serum potassium<br> Change in renal function<br> Change in health related quality of life<br> Number of participants with adverse events as a measure of safety and tolerability<br> ;Primary end point(s): Ratio of urinary-albumin-to-creatinine-ratio (UACR) at Visit 5 (Day 90 +/- 2) to UACR at baseline;Timepoint(s) of evaluation of this end point: 90 days

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Change in serum potassium<br> Change in renal function<br> Change in health related quality of life<br> Number of participants with adverse events as a measure of safety and tolerability<br> ;<br> Timepoint(s) of evaluation of this end point: From baseline to 90 days<br> From baseline to 90 days<br> From baseline to 90 days<br> Up to 120 days<br>