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Evaluate the Efficacy and Safety of Once Daily Administration of Atrasentan Tablets (Low and High) Compared to Placebo in Reducing Residual Albuminuria in Type 2 Diabetic Patients With Nephropathy Who Are Treated With the Maximum Tolerated Labeled Dose of a Renin Angiotensin System (RAS) Inhibitor

NCT ID: NCT01356849

Last Updated: 2013-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-08-31

Brief Summary

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Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study. The objective of the study is to evaluate the efficacy and safety of once daily administration of atrasentan tablets (low dose and high dose) compared to placebo in reducing residual albuminuria in Type 2 diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose of a Renin Angiotensin System (RAS) inhibitor. If the patient is already receiving a maximum tolerated labeled daily dose of RAS inhibitor and a diuretic, he/she will complete 4 weeks of the Run-in Period on a dose that has not been adjusted. If the patient is currently not receiving a maximum labeled daily dose of a RAS inhibitor then the dose will be titrated up to the maximum tolerated labeled dose over the course of 4 to 8 weeks during the Run-in Period. It is expected that subjects not receiving a diuretic will have a diuretic added or titrated during this period to maximize RAS inhibition. Following titration to the maximum tolerated labeled dose, the patient will complete an additional 4 weeks of Run-In Period on an unchanged doses of RAS inhibitor and diuretics, unless medically contraindicated. The randomization will be stratified based on country where subjects are enrolled into the study, and the Week -1 Urinary Albumin to Creatinine Ratio (UACR) levels (\< or = 1000 mg/g \[113 mg/mmol\], or \> 1000 mg/g \[113 mg/mmol\]). Within each stratum, subjects will be randomly assigned in a 1:2:2 ratio to one of the following blinded treatment groups: Group A - Placebo once daily (QD) Group B - low dose atrasentan QD Group C - high dose atrasentan QD After the 12 weeks of study drug treatment, subjects will be followed up to 30 days.

Detailed Description

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Conditions

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Chronic Kidney Disease Diabetic Nephropathy

Keywords

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Endothelin Receptor Antagonists Proteinuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A - Placebo QD

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will take two tablets daily of placebo QD for 12 weeks during the treatment period.

Group B - Low dose Atrasentan QD

Group Type ACTIVE_COMPARATOR

Atrasentan

Intervention Type DRUG

Subjects will take two tablets daily of either low dose Atrasentan QD or high dose Atrasentan QD for 12 weeks during the treatment period.

Group C - High dose Atrasentan QD

Group Type ACTIVE_COMPARATOR

Atrasentan

Intervention Type DRUG

Subjects will take two tablets daily of either low dose Atrasentan QD or high dose Atrasentan QD for 12 weeks during the treatment period.

Interventions

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Atrasentan

Subjects will take two tablets daily of either low dose Atrasentan QD or high dose Atrasentan QD for 12 weeks during the treatment period.

Intervention Type DRUG

Placebo

Subjects will take two tablets daily of placebo QD for 12 weeks during the treatment period.

Intervention Type DRUG

Other Intervention Names

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ABT-627

Eligibility Criteria

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Inclusion Criteria

* Patient is \> or = 18 years old.
* 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 currently receiving an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II receptor blocker (ARB) (Renin Angiotensin System (RAS) inhibitor).
* For entry in the Run-in Period the patient must satisfy the following criteria based on the Screening laboratory values:

* Estimated glomerular filtration rate (eGFR) ≥ 30 and ≤ 75 mL/min/1.73m2 by Epidemiology Collaboration (EPI) formula
* Urinary Albumin to Creatinine Ratio (UACR) \> or = 300 and \< or = 3500 mg/g as determined by the geometric mean of the two morning void urine specimens obtained at the Screening visit (UACR \> or = 34 mg/mmol and \< or = 396 mg/mmol)
* Serum albumin \> or = 3.0 g/dL (30 g/L) - B-type Natriuretic Peptide (BNP) \< or = 200 pg/mL (57.8 pmol/L) \* Negative serum pregnancy test for female patients
* Systolic Blood Pressure (SBP) \> or = 110 mmHg and \< or = 180 mmHg
* Glucosylated hemoglobin A1c (HbA1c) \< or = 12%
* For entry in the Treatment Period the patient 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 adjustments of dose
* Diuretic at any dose unless medically contraindicated (with the exception of loop diuretics \> or = 120 mg QD of furosemide or \> or = 3.0 mg QD of bumetanide or \> or = 150 mg QD of ethacrynic acid or \> or = 60 mg QD of torasemide)
* Urinary Albumin to Creatinine Ratio (UACR) \> or = 200 and \< or = 3500 mg/g as determined by the median of the three morning void urine specimens obtained prior to the Week -1 visit (UACR \> or = 23 mg/mmol and \< or = 396 mg/mmol)
* Systolic blood pressure (SBP) \> or = 110 mmHg and \< or = 160 mmHg
* Serum Potassium \< or = 5.5 mEq/L (5.5 mmol/L)
* Negative serum pregnancy test for female patients

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 \> or = 120 mg QD of furosemide or \> or = 3.0 mg QD of bumetanide or \> or = 150 mg QD of ethacrynic acid or \> or = 60 mg QD of torasemide.
* Patient has a history of pulmonary edema.
* Patient has a history of pulmonary hypertension, or any lung diseases requiring oxygen therapy (i.e., chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis).
* Patient has a history of orthostatic hypotension within the past 6 months as defined by the presence of a supine-to-standing blood pressure decrease \> or = 20 mmHg systolic or \> or = 10 mmHg diastolic within 3 minutes of standing.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Blai Coll, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 46345

Pell City, Alabama, United States

Site Status

Site Reference ID/Investigator# 46035

Tempe, Arizona, United States

Site Status

Site Reference ID/Investigator# 46016

Azusa, California, United States

Site Status

Site Reference ID/Investigator# 45992

Chula Vista, California, United States

Site Status

Site Reference ID/Investigator# 46000

La Mesa, California, United States

Site Status

Site Reference ID/Investigator# 46038

Lincoln, California, United States

Site Status

Site Reference ID/Investigator# 45994

Long Beach, California, United States

Site Status

Site Reference ID/Investigator# 45998

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 47584

Los Gatos, California, United States

Site Status

Site Reference ID/Investigator# 64465

National City, California, United States

Site Status

Site Reference ID/Investigator# 65862

Orange, California, United States

Site Status

Site Reference ID/Investigator# 46019

Riverside, California, United States

Site Status

Site Reference ID/Investigator# 46110

Salinas, California, United States

Site Status

Site Reference ID/Investigator# 46017

Yuba City, California, United States

Site Status

Site Reference ID/Investigator# 46662

Westminster, Colorado, United States

Site Status

Site Reference ID/Investigator# 46033

Coral Gables, Florida, United States

Site Status

Site Reference ID/Investigator# 45989

Hialeah, Florida, United States

Site Status

Site Reference ID/Investigator# 46667

Lauderdale Lakes, Florida, United States

Site Status

Site Reference ID/Investigator# 46123

Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 46115

Ocala, Florida, United States

Site Status

Site Reference ID/Investigator# 46664

Pembroke Pines, Florida, United States

Site Status

Site Reference ID/Investigator# 46031

Pembroke Pines, Florida, United States

Site Status

Site Reference ID/Investigator# 46040

Pembroke Pines, Florida, United States

Site Status

Site Reference ID/Investigator# 46122

Port Charlotte, Florida, United States

Site Status

Site Reference ID/Investigator# 46015

West Palm Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 50482

Jonesboro, Georgia, United States

Site Status

Site Reference ID/Investigator# 46034

Meridian, Idaho, United States

Site Status

Site Reference ID/Investigator# 46666

Chicago, Illinois, United States

Site Status

Site Reference ID/Investigator# 45996

Evergreen Park, Illinois, United States

Site Status

Site Reference ID/Investigator# 46002

Gurnee, Illinois, United States

Site Status

Site Reference ID/Investigator# 46111

Shreveport, Louisiana, United States

Site Status

Site Reference ID/Investigator# 46030

Oxon Hill, Maryland, United States

Site Status

Site Reference ID/Investigator# 45991

Rockville, Maryland, United States

Site Status

Site Reference ID/Investigator# 46025

Novi, Michigan, United States

Site Status

Site Reference ID/Investigator# 46023

Brooklyn Center, Minnesota, United States

Site Status

Site Reference ID/Investigator# 46062

Farmington, Missouri, United States

Site Status

Site Reference ID/Investigator# 48942

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 46349

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 46116

Las Vegas, Nevada, United States

Site Status

Site Reference ID/Investigator# 50483

Albany, New York, United States

Site Status

Site Reference ID/Investigator# 68328

New Hyde Park, New York, United States

Site Status

Site Reference ID/Investigator# 65863

Asheville, North Carolina, United States

Site Status

Site Reference ID/Investigator# 50529

Greensboro, North Carolina, United States

Site Status

Site Reference ID/Investigator# 46129

Greenville, North Carolina, United States

Site Status

Site Reference ID/Investigator# 46022

Morehead City, North Carolina, United States

Site Status

Site Reference ID/Investigator# 46224

Doylestown, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 46028

Orangeburg, South Carolina, United States

Site Status

Site Reference ID/Investigator# 46702

Orangeburg, South Carolina, United States

Site Status

Site Reference ID/Investigator# 46024

Greenville, Texas, United States

Site Status

Site Reference ID/Investigator# 46228

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 47068

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 64464

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 64483

Mission, Texas, United States

Site Status

Site Reference ID/Investigator# 46348

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 46063

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 68486

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 46669

Bennington, Vermont, United States

Site Status

Site Reference ID/Investigator# 46026

Alexandria, Virginia, United States

Site Status

Site Reference ID/Investigator# 46027

Fairfax, Virginia, United States

Site Status

Site Reference ID/Investigator# 67762

Kitchener, , Canada

Site Status

Site Reference ID/Investigator# 50526

Sarnia, , Canada

Site Status

Site Reference ID/Investigator# 50525

Thornhill, , Canada

Site Status

Site Reference ID/Investigator# 47067

Caguas, , Puerto Rico

Site Status

Site Reference ID/Investigator# 50522

Manatí, , Puerto Rico

Site Status

Site Reference ID/Investigator# 46352

Ponce, , Puerto Rico

Site Status

Site Reference ID/Investigator# 46351

Ponce, , Puerto Rico

Site Status

Site Reference ID/Investigator# 46133

Ponce, , Puerto Rico

Site Status

Site Reference ID/Investigator# 46131

Rio Piedras, , Puerto Rico

Site Status

Site Reference ID/Investigator# 46132

San Juan, , Puerto Rico

Site Status

Site Reference ID/Investigator# 46230

Santurce, , Puerto Rico

Site Status

Site Reference ID/Investigator# 51566

Taichung, , Taiwan

Site Status

Site Reference ID/Investigator# 51567

Taichung, , Taiwan

Site Status

Countries

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United States Canada Puerto Rico Taiwan

References

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Smeijer JD, Kohan DE, Rossing P, Correa-Rotter R, Liew A, Tang SCW, de Zeeuw D, Gansevoort RT, Ju W, Lambers Heerspink HJ. Insulin resistance, kidney outcomes and effects of the endothelin receptor antagonist atrasentan in patients with type 2 diabetes and chronic kidney disease. Cardiovasc Diabetol. 2023 Sep 16;22(1):251. doi: 10.1186/s12933-023-01964-8.

Reference Type DERIVED
PMID: 37716952 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28756065 (View on PubMed)

Other Identifiers

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M11-350

Identifier Type: -

Identifier Source: org_study_id