Phase
Condition
Diabetes And Hypertension
Diabetes Mellitus Types I And Ii
Diabetic Kidney Disease
Treatment
N/AClinical Study ID
Ages 20-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient has Type 2 diabetes and has been treated with at least one anti-hyperglycemicmedication within the 12 months prior to the screening period.
Patient is receiving a maximum tolerated labeled dose of an ACEi (AngiotensinConverting Enzyme inhibitor) or ARB (Angiotensin II Receptor Blocker)(ReninAngiotensin System (RAS) inhibitor). Estimated GFR (Glomerular Filtration Rate) isgreater than or equal to 30 and less than or equal to 75 mL/min/1.73m2 by the CKD (chronic kidney disease)
Epidemiology Collaboration (EPI) formula.
UACR (Urinary Albumin to Creatinine Ratio) is greater than or equal to 200 mg/g asdetermined by the geometric mean of the three morning void urine specimens obtained atRun-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 orequal to 160 mmHg. HbA1c (Glucosylated Hemoglobin A1c) is less than or equal to 12%and serum potassium is less than or equal to 5.5 mEq/L.
Exclusion
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) offurosemide or greater than or equal to 3.0 mg QD (Once Daily) of bumetanide or greaterthan 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 Enzymeinhibitor) and ARB (Angiotensin II Receptor Blocker) or rosiglitazone or aliskiren oran aldosterone antagonist and patient is receiving pioglitazone and edema is present.
Study Design
Connect with a study center
Site Reference ID/Investigator# 62022
Azumino,
JapanSite Not Available
Site Reference ID/Investigator# 58124
Chiba,
JapanSite Not Available
Site Reference ID/Investigator# 57486
Fujisawa,
JapanSite Not Available
Site Reference ID/Investigator# 55097
Ibaraki,
JapanSite Not Available
Site Reference ID/Investigator# 56982
Ina,
JapanSite Not Available
Site Reference ID/Investigator# 55093
Kawagoe,
JapanSite Not Available
Site Reference ID/Investigator# 57485
Kawasaki,
JapanSite Not Available
Site Reference ID/Investigator# 55092
Koriyama,
JapanSite Not Available
Site Reference ID/Investigator# 56524
Matsumoto,
JapanSite Not Available
Site Reference ID/Investigator# 57242
Nagano,
JapanSite Not Available
Site Reference ID/Investigator# 55781
Nagoya,
JapanSite Not Available
Site Reference ID/Investigator# 60965
Nagoya-city,
JapanSite Not Available
Site Reference ID/Investigator# 55304
Suwa,
JapanSite Not Available
Site Reference ID/Investigator# 59474
Tokyo,
JapanSite Not Available
Site Reference ID/Investigator# 59967
Ueda,
JapanSite Not Available
Site Reference ID/Investigator# 55095
Yokohama,
JapanSite Not Available
Site Reference ID/Investigator# 57484
Yokohama,
JapanSite Not Available
Site Reference ID/Investigator# 59842
Yokohama,
JapanSite Not Available

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