Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan

Last updated: August 25, 2017
Sponsor: AbbVie (prior sponsor, Abbott)
Overall Status: Completed

Phase

2

Condition

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Diabetic Kidney Disease

Treatment

N/A

Clinical Study ID

NCT01424319
M12-812
  • Ages 20-99
  • All Genders

Study Summary

Prospective, randomized, double-blind, placebo controlled, 12-week, multicenter study. The objective of the study is to evaluate the efficacy and safety of once daily administration of atrasentan tablets compared to placebo in reducing residual albuminuria in Japanese Type 2 diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose for hypertension of a RAS (renin angiotensin system) inhibitor.

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

Total Participants: 58
Study Start date:
August 01, 2011
Estimated Completion Date:
July 31, 2012

Connect with a study center

  • Site Reference ID/Investigator# 62022

    Azumino,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 58124

    Chiba,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 57486

    Fujisawa,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 55097

    Ibaraki,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 56982

    Ina,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 55093

    Kawagoe,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 57485

    Kawasaki,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 55092

    Koriyama,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 56524

    Matsumoto,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 57242

    Nagano,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 55781

    Nagoya,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 60965

    Nagoya-city,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 55304

    Suwa,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 59474

    Tokyo,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 59967

    Ueda,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 55095

    Yokohama,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 57484

    Yokohama,
    Japan

    Site Not Available

  • Site Reference ID/Investigator# 59842

    Yokohama,
    Japan

    Site Not Available

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