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Chronic Kidney DiseasePhase 2RADARNCT01356849

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

A Phase 2 study testing Atrasentan in people with Chronic Kidney Disease and Diabetic Nephropathy, run by AbbVie (prior sponsor, Abbott) at 72 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease, Diabetic Nephropathy
What is being tested?
Atrasentan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
149 participants
Where
72 sitesin 4 countries
Study dates
Apr 2011to Aug 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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.

Trial locations and contacts

72 sites in 4 countries.

72 sites in 4 countries

United States59 sites

  • Site Reference ID/Investigator# 50483

    Albany, New York, 12206

  • Site Reference ID/Investigator# 46026

    Alexandria, Virginia, 22304

  • Site Reference ID/Investigator# 65863

    Asheville, North Carolina, 28801

  • Site Reference ID/Investigator# 46016

    Azusa, California, 91702

  • Site Reference ID/Investigator# 46669

    Bennington, Vermont, 05201

  • Site Reference ID/Investigator# 46023

    Brooklyn Center, Minnesota, 55430

  • Site Reference ID/Investigator# 46666

    Chicago, Illinois, 60616

  • Site Reference ID/Investigator# 45992

    Chula Vista, California, 91910

  • Site Reference ID/Investigator# 46033

    Coral Gables, Florida, 33134

  • Site Reference ID/Investigator# 46224

    Doylestown, Pennsylvania, 18901

  • Site Reference ID/Investigator# 45996

    Evergreen Park, Illinois, 60805

  • Site Reference ID/Investigator# 46027

    Fairfax, Virginia, 22030

  • Site Reference ID/Investigator# 46062

    Farmington, Missouri, 63640

  • Site Reference ID/Investigator# 50529

    Greensboro, North Carolina, 27408

  • Site Reference ID/Investigator# 46129

    Greenville, North Carolina, 27834

  • Site Reference ID/Investigator# 46024

    Greenville, Texas, 75402

  • Site Reference ID/Investigator# 46002

    Gurnee, Illinois, 60031

  • Site Reference ID/Investigator# 45989

    Hialeah, Florida, 33012

  • Site Reference ID/Investigator# 46228

    Houston, Texas, 77004

  • Site Reference ID/Investigator# 47068

    Houston, Texas, 77004

  • Site Reference ID/Investigator# 64464

    Houston, Texas, 77054

  • Site Reference ID/Investigator# 50482

    Jonesboro, Georgia, 30236

  • Site Reference ID/Investigator# 46000

    La Mesa, California, 91942

  • Site Reference ID/Investigator# 46116

    Las Vegas, Nevada, 89106

  • Site Reference ID/Investigator# 46667

    Lauderdale Lakes, Florida, 33313

  • Site Reference ID/Investigator# 46038

    Lincoln, California, 95648

  • Site Reference ID/Investigator# 45994

    Long Beach, California, 90806

  • Site Reference ID/Investigator# 45998

    Los Angeles, California, 90022

  • Site Reference ID/Investigator# 47584

    Los Gatos, California, 95032

  • Site Reference ID/Investigator# 46034

    Meridian, Idaho, 83642

  • Site Reference ID/Investigator# 46123

    Miami, Florida, 33135

  • Site Reference ID/Investigator# 64483

    Mission, Texas, 78572

  • Site Reference ID/Investigator# 46022

    Morehead City, North Carolina, 28557

  • Site Reference ID/Investigator# 64465

    National City, California, 91950

  • Site Reference ID/Investigator# 68328

    New Hyde Park, New York, 11042

  • Site Reference ID/Investigator# 46025

    Novi, Michigan, 48374

  • Site Reference ID/Investigator# 46115

    Ocala, Florida, 34471

  • Site Reference ID/Investigator# 48942

    Omaha, Nebraska, 68131-3403

  • Site Reference ID/Investigator# 46349

    Omaha, Nebraska, 68131

  • Site Reference ID/Investigator# 65862

    Orange, California, 92868

  • Site Reference ID/Investigator# 46028

    Orangeburg, South Carolina, 29118

  • Site Reference ID/Investigator# 46702

    Orangeburg, South Carolina, 29118

  • Site Reference ID/Investigator# 46030

    Oxon Hill, Maryland, 20745

  • Site Reference ID/Investigator# 46345

    Pell City, Alabama, 35128

  • Site Reference ID/Investigator# 46664

    Pembroke Pines, Florida, 33027

  • Site Reference ID/Investigator# 46031

    Pembroke Pines, Florida, 33028

  • Site Reference ID/Investigator# 46040

    Pembroke Pines, Florida, 33028

  • Site Reference ID/Investigator# 46122

    Port Charlotte, Florida, 33952

  • Site Reference ID/Investigator# 46019

    Riverside, California, 92505

  • Site Reference ID/Investigator# 45991

    Rockville, Maryland, 20852

  • Site Reference ID/Investigator# 46110

    Salinas, California, 93901

  • Site Reference ID/Investigator# 46348

    San Antonio, Texas, 78215

  • Site Reference ID/Investigator# 46063

    San Antonio, Texas, 78229-4801

  • Site Reference ID/Investigator# 68486

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 46111

    Shreveport, Louisiana, 71101

  • Site Reference ID/Investigator# 46035

    Tempe, Arizona, 85284

  • Site Reference ID/Investigator# 46015

    West Palm Beach, Florida, 33401

  • Site Reference ID/Investigator# 46662

    Westminster, Colorado, 80031

  • Site Reference ID/Investigator# 46017

    Yuba City, California, 95991

Other trials in United States

Puerto Rico8 sites

  • Site Reference ID/Investigator# 47067

    Caguas, 00725

  • Site Reference ID/Investigator# 50522

    Manati, 00674

  • Site Reference ID/Investigator# 46352

    Ponce, 00717-1322

  • Site Reference ID/Investigator# 46351

    Ponce, 00717-2075

  • Site Reference ID/Investigator# 46133

    Ponce, 00717

  • Site Reference ID/Investigator# 46131

    Rio Piedras, 00935

  • Site Reference ID/Investigator# 46132

    San Juan, 00918

  • Site Reference ID/Investigator# 46230

    Santurce, 00909-2244

Other trials in Puerto Rico

Canada3 sites

  • Site Reference ID/Investigator# 67762

    Kitchener, N2H 5Z8

  • Site Reference ID/Investigator# 50526

    Sarnia, N7T 4X3

  • Site Reference ID/Investigator# 50525

    Thornhill, L4J 8L7

Other trials in Canada

Taiwan2 sites

  • Site Reference ID/Investigator# 51566

    Taichung, 40447

  • Site Reference ID/Investigator# 51567

    Taichung, 40705

Other trials in Taiwan

About this study

Official title: RADAR: Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With AtRasentan - A Phase 2b, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Safety and Efficacy

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.

Being tested
Atrasentan, Placebo
Keywords
Endothelin Receptor Antagonists, Proteinuria
Medical subject headings
Renal Insufficiency, Chronic, Diabetic Nephropathies, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtrasentanDrug

    Also called ABT-627

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

  • PlaceboDrug

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

Study groups in NCT01356849
Study groupRoleWhat they receive
Group A - Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo
Group B - Low dose Atrasentan QDActive comparatorNot described
Receives: Drug: Atrasentan
Group C - High dose Atrasentan QDActive comparatorNot described
Receives: Drug: Atrasentan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to Week 12 in Urinary Albumin to Creatinine Ratio (UACR)

    Measured: Every two weeks for 12 weeks

Secondary outcomes (3)

  1. Differences in change from baseline to each post baseline measure for estimated glomerular filtration rate (eGFR)

    Measured: Every two weeks for 12 weeks

  2. Differences in change from baseline to each post baseline measure for EQ-5D Index Score

    Measured: Once a month for 3 months

  3. Differences in change from baseline to each post baseline measure for each of the Kidney Disease Quality of Life (KDQOL) Kidney Disease Targeted Scales

    Measured: Once a month for 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01356849
Sponsor's protocol ID
M11-350
Acronym
RADAR
Status last verified
Aug 2013
First submitted
19 Apr 2011
Last updated
28 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37716952

  • 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.

    PubMed 28756065

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atrasentan in people with Chronic Kidney Disease and Diabetic Nephropathy, run by AbbVie (prior sponsor, Abbott) at 72 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Puerto Rico, Canada, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to Week 12 in Urinary Albumin to Creatinine Ratio (UACR) (time frame: Every two weeks for 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01356849, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.

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