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Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01424319
First received: August 25, 2011
Last updated: February 12, 2013
Last verified: February 2013

August 25, 2011
February 12, 2013
August 2011
July 2012   (final data collection date for primary outcome measure)
The change from baseline to each post-baseline visit in log-transformed UACR (urinary albumin to creatinine ratio) [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01424319 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
  • The change from baseline to each post-baseline visit on log-transformed UACR (Urinary Albumin to Creatinine Ratio) and estimated GFR (Glomerular Filtration Rate) [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve various percent of reduction in UACR (Urinary Albumin to Creatinine Ratio) from baseline to final [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
  • The proportion of subjects who have achieved at least 30% reduction on UACR who have not had any form of treatment-emergent edema with moderate or severe severity. [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
  • The change from baseline to each post-baseline visit on log-transformed UACR and estimated GFR (glomerular filtration rate) [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve various percent of reduction in UACR from baseline to final [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan
Reducing Residual Albuminuria in Subjects With Diabetes & Nephropathy With Atrasentan - A Phase 2b, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Safety & Efficacy in Japanese Subjects

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Diabetic Nephropathy
  • Drug: Atrasentan low dose group
    Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.
  • Drug: Atrasentan high dose group
    Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.
  • Drug: Atrasentan placebo group
    Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.
  • Experimental: ABT-627, Low dose
    Intervention: Drug: Atrasentan low dose group
  • Experimental: ABT-627, High dose
    Intervention: Drug: Atrasentan high dose group
  • Placebo Comparator: ABT-627, Placebo
    Intervention: Drug: Atrasentan placebo group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
July 2012
July 2012   (final data collection date for primary outcome measure)

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 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 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% and serum potassium is less than or equal to 5.5 mEq/L.

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 and patient is receiving pioglitazone and edema is present.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01424319
M12-812
Yes
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Mosleh UDDIN, PharmD Abbott Japan Co.,Ltd
AbbVie
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP