Diabetic Nephropathy, Chronic Kidney Disease
Conditions
Interventions
investigational material(s)
Generic name etc : ABT-627
INN of investigational material : atrasentan
Therapeutic category code : 219 Other cardiovascular agents
Dosage and Administration for Investigat
Sponsors
Abbott Japan Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patient has Type 2 diabetes and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the screening period. -Patient is receiving a maximum tolerated labeled dose of an ACEi (Angiotensin Converting Enzyme inhibitor) or ARB (Angiotensin II Receptor Blocker)(Renin Angiotensin System (RAS) inhibitor). -Estimated GFR (Glomerular Filtration Rate) is greater than or equal to 30 and less than or equal to 75 mL/min/1.73m2. -UACR (Urinary Albumin to Creatinine Ratio) is greater than or equal to 200 mg/g as determined by the geometric mean of the three morning void urine specimens obtained at Run-in period. -Serum albumin is greater than or equal to 3.0 g/dL. -BNP (B-type Natriuretic Peptide) is less than or equal to 200 pg/mL. -SBP (Systolic Blood Pressure) is greater than or equal to 110 mmHg and less than or equal to 160 mmHg. -HbA1c (Glucosylated Hemoglobin A1c) is less than or equal to 12%. -Serum potassium is less than or equal to 5.5 mEq/L.
Exclusion criteria
Exclusion criteria: -Patient has a history of moderate or severe edema, facial edema unrelated to trauma, or a history of myxedema in the prior 6 months to screening. -Patient is receiving loop diuretics greater than or equal to 120 mg QD (Once Daily) of furosemide or greater than or equal to 3.0 mg QD (Once Daily) of bumetanide or greater than or equal to 150 mg QD (Once Daily) of ethacrynic acid or greater than or equal to 60 mg QD (Once Daily) of torasemide. -Patient has a documented history of Stage C or Stage D heart failure, defined ACC/AHA (American College of Cardiology/ American Heart Association Practice Guidelines). -Patient is receiving any of a combination of an ACEi (Angiotensin Converting Enzyme inhibitor) and ARB (Angiotensin II Receptor Blocker) or rosiglitazone or aliskiren or an aldosterone antagonist. -Patient is receiving pioglitazone and edema is present.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline to each post-baseline visit in log-transformed UACR (Urinary Albumin to Creatinine Ratio) Up to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| -The proportion of subjects who have achieved at least 30% reduction on UACR (Urinary Albumin to Creatinine Ratio) who have not had any form of treatment-emergent edema with moderate or severe severity. -The change from baseline to each post-baseline visit on log-transformed UACR (Urinary Albumin to Creatinine Ratio) and estimated GFR (Glomerular Filtration Rate). -The proportion of subjects who achieve various percent of reduction in UACR (Urinary Albumin to Creatinine Ratio) from baseline to final. Up to Week 12 | — |
Outcome results
None listed