Primary objective of the study is•To investigate the change of Urinary Albumin-to-Creatinine ratio (UCAR) after 90 days treatment Secondary objectives of the study are•To assess safety and tolerability of these doses by assessing the effects on…
ID
Source
Brief title
Condition
- Diabetic complications
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective of the study is
•To investigate the change of Urinary Albumin-to-Creatinine ratio (UCAR) after
90 days treatment
Secondary outcome
Secondary objectives of the study are
•To assess safety and tolerability of these doses by assessing the effects on
serum potassium and renal function
•To assess change in health-related quality of life from baseline to 90 days of
treatment assessed by the Kidney Disease Quality of Life (KDQL) and EQ-5D-3L
questionnaires
Background summary
Current therapies for Diabetic Nephropathy (DN) rely on the control of
proteinuria with Angiotensin Converting Enzyme Inhibitors (ACEIs) or
Angiotensin II receptor blockers (ARBs). Studies have shown a direct
relationship between an increase in plasma aldosterone after ACEI/ARBs
treatment and an increase in proteinuria and a decrease in kidney function.
There is an urgent need to evaluate novel therapies to improve
cardiovascular and renal outcomes in patients with diabetic nephropathy. The
study medication, BAY94-8862 is expected to have the potential to address the
unmet medical needs in patients with type 2 diabetes mellitus and the clinical
diagnosis of DN. In a previous study with BAY94-8862, albuminuria was reduced,
in particular in subjects with high and very high albuminuria at baseline. When
added to standard therapy with ACEIs or ARBs treatment, BAY94-8862 might lead
to a reduction in proteinuria compared with placebo on top of standard of care.
Study objective
Primary objective of the study is
•To investigate the change of Urinary Albumin-to-Creatinine ratio (UCAR) after
90 days treatment
Secondary objectives of the study are
•To assess safety and tolerability of these doses by assessing the effects on
serum potassium and renal function
•To assess change in health-related quality of life from baseline to 90 days of
treatment assessed by the Kidney Disease Quality of Life (KDQL) and EQ-5D-3L
questionnaires
Study design
Multi-center, randomized, adaptive, double-blind, placebo-controlled
parallel-group design
Intervention
Niet van toepassing.
Study burden and risks
Up to 8 study visits (Maximum study duration is 216 days)
Blood samples at each study visit.
Urine sample collection at 7 visits (3 samples collected over 3 days)
Two questionnaires to complete at 4 visits. EQ-5D-3L - 2 pages in length and
KDQL consists of 36 questions.
Physical Examination at 5 visits.
ECG assessment at 7 visits.
Some patients may need to modify current medication before entering the study.
BAY94-8862 may have some therapeutic benefit, however this cannot be
guaranteed. Patients are at risk of experiencing side effects.
Energieweg 1
Mijdrecht 3641 RT
NL
Energieweg 1
Mijdrecht 3641 RT
NL
Listed location countries
Age
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 treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), but not both, for at least 3 months;Serum potassium
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-004179-38-NL |
| ClinicalTrials.gov | NCT01874431 |
| CCMO | NL44508.042.13 |