Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan

August 25, 2017 updated by: AbbVie (prior sponsor, Abbott)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Azumino, Japan
        • Site Reference ID/Investigator# 62022
      • Chiba, Japan
        • Site Reference ID/Investigator# 58124
      • Fujisawa, Japan
        • Site Reference ID/Investigator# 57486
      • Ibaraki, Japan
        • Site Reference ID/Investigator# 55097
      • Ina, Japan
        • Site Reference ID/Investigator# 56982
      • Kawagoe, Japan
        • Site Reference ID/Investigator# 55093
      • Kawasaki, Japan
        • Site Reference ID/Investigator# 57485
      • Koriyama, Japan
        • Site Reference ID/Investigator# 55092
      • Matsumoto, Japan
        • Site Reference ID/Investigator# 56524
      • Nagano, Japan
        • Site Reference ID/Investigator# 57242
      • Nagoya, Japan
        • Site Reference ID/Investigator# 55781
      • Nagoya-city, Japan
        • Site Reference ID/Investigator# 60965
      • Suwa, Japan
        • Site Reference ID/Investigator# 55304
      • Tokyo, Japan
        • Site Reference ID/Investigator# 59474
      • Ueda, Japan
        • Site Reference ID/Investigator# 59967
      • Yokohama, Japan
        • Site Reference ID/Investigator# 55095
      • Yokohama, Japan
        • Site Reference ID/Investigator# 57484
      • Yokohama, Japan
        • Site Reference ID/Investigator# 59842

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change from baseline to each post-baseline visit in log-transformed UACR (urinary albumin to creatinine ratio)
Time Frame: Up to Week 12
Up to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Up to Week 12
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
Up to Week 12
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
Up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Mosleh UDDIN, PharmD, Abbott Japan Co.,Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

August 25, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (ESTIMATE)

August 29, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12-812

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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