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Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan

Primary Purpose

Chronic Kidney Disease, Diabetic Nephropathy

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Atrasentan low dose group
Atrasentan high dose group
Atrasentan placebo group
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Endothelin Receptor Antagonists, Proteinuria

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site Reference ID/Investigator# 62022
  • Site Reference ID/Investigator# 58124
  • Site Reference ID/Investigator# 57486
  • Site Reference ID/Investigator# 55097
  • Site Reference ID/Investigator# 56982
  • Site Reference ID/Investigator# 55093
  • Site Reference ID/Investigator# 57485
  • Site Reference ID/Investigator# 55092
  • Site Reference ID/Investigator# 56524
  • Site Reference ID/Investigator# 57242
  • Site Reference ID/Investigator# 60965
  • Site Reference ID/Investigator# 55781
  • Site Reference ID/Investigator# 55304
  • Site Reference ID/Investigator# 59474
  • Site Reference ID/Investigator# 59967
  • Site Reference ID/Investigator# 55095
  • Site Reference ID/Investigator# 57484
  • Site Reference ID/Investigator# 59842

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ABT-627, Low dose

ABT-627, High dose

ABT-627, Placebo

Arm Description

Outcomes

Primary Outcome Measures

The change from baseline to each post-baseline visit in log-transformed UACR (urinary albumin to creatinine ratio)

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.
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

Full Information

First Posted
August 25, 2011
Last Updated
August 25, 2017
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT01424319
Brief Title
Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Diabetic Nephropathy
Keywords
Endothelin Receptor Antagonists, Proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-627, Low dose
Arm Type
Experimental
Arm Title
ABT-627, High dose
Arm Type
Experimental
Arm Title
ABT-627, Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Atrasentan low dose group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atrasentan high dose group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atrasentan placebo group
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change from baseline to each post-baseline visit in log-transformed UACR (urinary albumin to creatinine ratio)
Time Frame
Up to Week 12
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mosleh UDDIN, PharmD
Organizational Affiliation
Abbott Japan Co.,Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 62022
City
Azumino
Country
Japan
Facility Name
Site Reference ID/Investigator# 58124
City
Chiba
Country
Japan
Facility Name
Site Reference ID/Investigator# 57486
City
Fujisawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 55097
City
Ibaraki
Country
Japan
Facility Name
Site Reference ID/Investigator# 56982
City
Ina
Country
Japan
Facility Name
Site Reference ID/Investigator# 55093
City
Kawagoe
Country
Japan
Facility Name
Site Reference ID/Investigator# 57485
City
Kawasaki
Country
Japan
Facility Name
Site Reference ID/Investigator# 55092
City
Koriyama
Country
Japan
Facility Name
Site Reference ID/Investigator# 56524
City
Matsumoto
Country
Japan
Facility Name
Site Reference ID/Investigator# 57242
City
Nagano
Country
Japan
Facility Name
Site Reference ID/Investigator# 60965
City
Nagoya-city
Country
Japan
Facility Name
Site Reference ID/Investigator# 55781
City
Nagoya
Country
Japan
Facility Name
Site Reference ID/Investigator# 55304
City
Suwa
Country
Japan
Facility Name
Site Reference ID/Investigator# 59474
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59967
City
Ueda
Country
Japan
Facility Name
Site Reference ID/Investigator# 55095
City
Yokohama
Country
Japan
Facility Name
Site Reference ID/Investigator# 57484
City
Yokohama
Country
Japan
Facility Name
Site Reference ID/Investigator# 59842
City
Yokohama
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24722445
Citation
de Zeeuw D, Coll B, Andress D, Brennan JJ, Tang H, Houser M, Correa-Rotter R, Kohan D, Lambers Heerspink HJ, Makino H, Perkovic V, Pritchett Y, Remuzzi G, Tobe SW, Toto R, Viberti G, Parving HH. The endothelin antagonist atrasentan lowers residual albuminuria in patients with type 2 diabetic nephropathy. J Am Soc Nephrol. 2014 May;25(5):1083-93. doi: 10.1681/ASN.2013080830. Epub 2014 Apr 10.
Results Reference
result
PubMed Identifier
26153128
Citation
Kohan DE, Lambers Heerspink HJ, Coll B, Andress D, Brennan JJ, Kitzman DW, Correa-Rotter R, Makino H, Perkovic V, Hou FF, Remuzzi G, Tobe SW, Toto R, Parving HH, de Zeeuw D. Predictors of Atrasentan-Associated Fluid Retention and Change in Albuminuria in Patients with Diabetic Nephropathy. Clin J Am Soc Nephrol. 2015 Sep 4;10(9):1568-74. doi: 10.2215/CJN.00570115. Epub 2015 Jul 7.
Results Reference
result
PubMed Identifier
28756065
Citation
Lin CW, Mostafa NM, L Andress D, J Brennan J, Klein CE, Awni WM. Relationship Between Atrasentan Concentrations and Urinary Albumin to Creatinine Ratio in Western and Japanese Patients With Diabetic Nephropathy. Clin Ther. 2018 Feb;40(2):242-251. doi: 10.1016/j.clinthera.2017.07.011. Epub 2017 Jul 27.
Results Reference
derived

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Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan

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