A Prospective, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of Atrasentan, Including Thoracic Bioimpedance, in Type 2 Diabetic Subjects With Nephropathy

September 25, 2013 updated by: AbbVie (prior sponsor, Abbott)

A Phase 2b, Prospective, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of Atrasentan, Including Thoracic Bioimpedance, in Type 2 Diabetic Subjects With Nephropathy

Prospective, Randomized, Double-Blind, Parallel Design, Placebo-Controlled Multicenter Study. The study objectives are to evaluate efficacy and safety, including thoracic bioimpedance, of once daily administration of atrasentan tablets (high dose and low dose) compared to placebo in type 2 diabetic subjects with nephropathy who are receiving the maximum tolerated labeled daily dose of a RAS inhibitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Site Reference ID/Investigator# 58144
      • Tempe, Arizona, United States, 85284
        • Site Reference ID/Investigator# 71034
    • California
      • Azusa, California, United States, 91702
        • Site Reference ID/Investigator# 56927
      • Azusa, California, United States, 91702
        • Site Reference ID/Investigator# 70793
      • Chula Vista, California, United States, 91910
        • Site Reference ID/Investigator# 64027
      • Concord, California, United States, 94520
        • Site Reference ID/Investigator# 54120
      • La Mesa, California, United States, 91942
        • Site Reference ID/Investigator# 64026
      • Los Angeles, California, United States, 90048
        • Site Reference ID/Investigator# 70173
    • Colorado
      • Denver, Colorado, United States, 80209
        • Site Reference ID/Investigator# 54121
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Site Reference ID/Investigator# 56924
      • Hollywood, Florida, United States, 33021
        • Site Reference ID/Investigator# 56642
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Site Reference ID/Investigator# 68986
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Site Reference ID/Investigator# 56644
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Site Reference ID/Investigator# 54129
    • Michigan
      • Pontiac, Michigan, United States, 48341
        • Site Reference ID/Investigator# 68982
    • New York
      • Albany, New York, United States, 12206
        • Site Reference ID/Investigator# 64023
      • Flushing, New York, United States, 11355
        • Site Reference ID/Investigator# 55543
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Site Reference ID/Investigator# 54164
    • Ohio
      • Willoughby Hills, Ohio, United States, 44094
        • Site Reference ID/Investigator# 58147
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Site Reference ID/Investigator# 54123
      • Pittsburg, Pennsylvania, United States, 15224
        • Site Reference ID/Investigator# 61742
    • Tennessee
      • Chattanooga, Tennessee, United States, 37408
        • Site Reference ID/Investigator# 54132
    • Texas
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 54108
      • Greenville, Texas, United States, 75402
        • Site Reference ID/Investigator# 54126
      • Houston, Texas, United States, 77024
        • Site Reference ID/Investigator# 58153
      • Houston, Texas, United States, 77099
        • Site Reference ID/Investigator# 54110
      • North Richland Hills, Texas, United States, 76180
        • Site Reference ID/Investigator# 54116
    • Washington
      • Silverdale, Washington, United States, 98383
        • Site Reference ID/Investigator# 54173

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is greater than or equal to 18 years old.
  2. Subject has type 2 diabetes and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the Screening Period.
  3. Subject is currently receiving an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II receptor blocker (ARB) (Renin Angiotensin System (RAS) inhibitor).
  4. If female, subject is not breastfeeding and is not pregnant (verified by negative serum pregnancy test prior to the Treatment Period). Subject is not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or is of childbearing potential and practicing one of the approved methods of birth control as defined in the Clinical Trial Protocol. Contraception must be used during the study and for 4 weeks after the last dose of study drug.

  5. For entry into the Run-in Period the subject must satisfy the following criteria based on the Screening laboratory values:

    • Estimated glomerular filtration rate (eGFR) greater than or equal to 30 and less than or equal to 75 mL/min/1.73m^2 by the Epidemiology Collaboration (EPI) formula
    • Urinary Albumin to Creatinine Ratio (UACR) greater than or equal to 300 and less than or equal to 3500 mg/g as determined by the geometric mean of the two morning void urine specimens obtained at the Screening visit
    • Serum albumin greater than or equal to 3.0 g/dL
    • B-Type Natriuretic Peptide (BNP) less than or equal to 200 pg/mL
    • Negative serum pregnancy test for female subjects
    • Systolic Blood Pressure (SBP) greater than or equal to 110 mmHg and less than or equal to 180 mmHg
    • Glucosylated hemoglobin (HbA1c) less than or equal to 12%

  6. For entry into the Treatment Period the subject must satisfy the following criteria based on the last visit of the Run-in Period laboratory values:

    • Renin Angiotensin System (RAS) inhibitor at maximum tolerated labeled dose for the previous 4 weeks with no adjustment of dose
    • Diuretic at any dose unless medically contraindicated (with the exception of loop diuretics greater than or equal to 120 mg QD of furosemide or greater than or equal to 3.0 mg QD of bumetanide or greater than or equal to 150 mg QD of ethacrynic acid or greater than or equal to 60 mg QD of torasemide)
    • UACR ≥ 200 mg/g as determined by the median of the three morning void urine specimens obtained prior to the Week -1 visit
    • Systolic Blood Pressure (SBP) greater than or equal to 110 mmHg and less than or equal to 160 mmHg
    • Serum Potassium less than or equal to 5.5 mEq/L
    • Negative serum pregnancy test for female subjects

Exclusion Criteria:

  1. 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.
  2. Subject is receiving loop diuretics greater than or equal to 120 mg QD of furosemide or greater than or equal to 3.0 mg QD of bumetanide or greater than or equal to 150 mg QD of ethacrynic acid or greater than or equal to 60 mg QD of torasemide.
  3. Subject has a history of pulmonary edema.
  4. Subject has a history of pulmonary hypertension, or any lung diseases requiring oxygen therapy (i.e., chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis).
  5. Subject has a history of orthostatic hypotension within the past 6 months as defined by the presence of a supine-to-standing blood pressure decrease greater than or equal to 20 mmHg systolic or greater than or equal to 10 mmHg diastolic within 3 minutes of standing.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group A - Placebo QD
Drug: Placebo
Subjects will take two tablets daily of placebo QD for 8 weeks during the treatment period.
Active Comparator: Group B - Low dose Atrasentan QD
Drug: Atrasentan
Subjects will take two tablets daily of either low dose Atrasentan QD or high dose Atrasentan QD for 8 weeks during the treatment period.
Other Names:
  • ABT-627
Active Comparator: Group C - High dose Atrasentan QD
Drug: Atrasentan
Subjects will take two tablets daily of either low dose Atrasentan QD or high dose Atrasentan QD for 8 weeks during the treatment period.
Other Names:
  • ABT-627

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to each post-baseline visit up to Week 8 in log-transformed Urinary Albumin to Creatinine Ratio (UACR)
Time Frame: Every two weeks for 8 weeks
Every two weeks for 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to each post baseline measure for estimated glomerular filtration rate (eGFR)
Time Frame: Every two weeks for 8 weeks
Every two weeks for 8 weeks
The change from baseline to each post-baseline assessment of thoracic bioimpedance
Time Frame: Treatment Day 1, Week 1, 2, 4, 6, 8 and 30 days post-treatment
Treatment Day 1, Week 1, 2, 4, 6, 8 and 30 days post-treatment

Collaborators and Investigators

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

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Blai Coll, MD, AbbVie

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)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

July 20, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

October 25, 2013

Last Update Submitted That Met QC Criteria

September 25, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12-830

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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