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
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Diabetic Nephropathy
Drug: Atrasentan low dose group
Drug: Atrasentan high dose group
Drug: Atrasentan placebo group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 58
Study Start Date: August 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-627, Low dose 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.
Experimental: ABT-627, High dose 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.
Placebo Comparator: ABT-627, Placebo 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424319

Locations
Japan
Site Reference ID/Investigator# 62022
Azumino, Japan
Site Reference ID/Investigator# 58124
Chiba, Japan
Site Reference ID/Investigator# 57486
Fujisawa, Japan
Site Reference ID/Investigator# 55097
Ibaraki, Japan
Site Reference ID/Investigator# 56982
Ina, Japan
Site Reference ID/Investigator# 55093
Kawagoe, Japan
Site Reference ID/Investigator# 57485
Kawasaki, Japan
Site Reference ID/Investigator# 55092
Koriyama, Japan
Site Reference ID/Investigator# 56524
Matsumoto, Japan
Site Reference ID/Investigator# 57242
Nagano, Japan
Site Reference ID/Investigator# 55781
Nagoya, Japan
Site Reference ID/Investigator# 60965
Nagoya-city, Japan
Site Reference ID/Investigator# 55304
Suwa, Japan
Site Reference ID/Investigator# 59474
Tokyo, Japan
Site Reference ID/Investigator# 59967
Ueda, Japan
Site Reference ID/Investigator# 55095
Yokohama, Japan
Site Reference ID/Investigator# 59842
Yokohama, Japan
Site Reference ID/Investigator# 57484
Yokohama, Japan
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Mosleh UDDIN, PharmD Abbott Japan Co.,Ltd
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01424319     History of Changes
Other Study ID Numbers: M12-812
Study First Received: August 25, 2011
Last Updated: February 12, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Endothelin Receptor Antagonists
Proteinuria

Additional relevant MeSH terms:
Albuminuria
Diabetic Nephropathies
Kidney Diseases
Renal Insufficiency, Chronic
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 26, 2014