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A Study of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Treated With Renin-Angiotensin System Inhibitors | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Treated With Renin-Angiotensin System Inhibitors

A Phase 2a, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Safety and Efficacy of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Subjects Who Are Currently Being Treated With an Renin-Angiotensin System Inhibitor

NCT00920764•AbbVie (prior sponsor, Abbott)

View on ClinicalTrials.gov

Summary

The study objective is to investigate the effects of three low doses of atrasentan on urinary albumin/creatinine ratio (UACR) levels in subjects with Type 2 diabetic nephropathy. Patients with Type 2 diabetes with nephropathy must be receiving a renin-angiotensin system inhibitor, such as an Angiotensin converting enzyme inhibitor (ACEi) or an Angiotensin II Receptor Blocker (ARB) for participation in this study. ACEi and ARB treatment are the standard of care for the management of proteinuria in Chronic Kidney Disease (CKD) patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1.Subject is \>= 18 years old.
•2.Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
•3.Subject has Type 2 diabetes and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the Screening Phase.
•4.Subject has been receiving a stable dose (i.e., same type and regimen) of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin receptor blocking agents (ARB) for at least 2 months prior to the Screening Phase.
•5.If female, subject must be not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). The reason for non-childbearing potential must be specified in the subject's eCRF.
•6.If male, subject must be surgically sterile or if sexually active and of childbearing potential, the site must document the lack of desire for future procreation and subject must agree to use a condom and a second reliable barrier of contraception from the Screening Visit through two months following completion of their participation in the study.
•7.For entry into the Treatment Phase the subject must satisfy the following criteria based on Screening laboratory values:
•* a.Estimated GFR \> 20 mL/min/1.73 m2 by simplified MDRD formula
•* b.UACR between 100 and 3000 mg/g as determined at the initial Screening visit or by the mean of the 2 morning void urine specimens obtained prior to the second Screening visit.
•* c.Serum albumin \> 3.0 g/dL.
+3 more criteria

Exclusion Criteria

•1.Subject has a history of significant peripheral edema (2 + or greater), or facial edema unrelated to trauma, or a history of myxedema in the 6 months prior to Screening.
•2.Subject receiving loop diuretics \> 30 mg BID of furosemide or \> 0.5 mg BID of bumetanide or \> 25 mg BID of ethacrynic acid.
•3.Subject has a history of pulmonary edema.
•4.Subject has a history of pulmonary hypertension, chronic obstructive pulmonary disease, emphysema, pulmonary fibrous disease, asthma or other lung disease that requires oxygen.
•5.Subject has a documented history of heart failure, defined as New York Heart Association (NYHA) Class II, III or IV heart failure.
•6.Subject has a body mass index (BMI) \> 40.
•7.Subject has elevated liver enzymes (ALT and/or AST) \> 1.5 x the upper limit of normal (ULN).
•8.Subject has a hemoglobin \< 9.5 g/dL.
•9.Subject has a history of an allergic reaction or significant sensitivity to atrasentan or its excipients.
•10.Subject has a history of a chronic gastrointestinal disease, which in the Investigator's opinion may cause significant GI malabsorption.
+14 more criteria

Locations (28)

Site Reference ID/Investigator# 19386

Tempe, Arizona, United States

Site Reference ID/Investigator# 25043

Azusa, California, United States

Site Reference ID/Investigator# 23308

Los Angeles, California, United States

Site Reference ID/Investigator# 25430

Los Angeles, California, United States

Site Reference ID/Investigator# 20421

San Diego, California, United States

Site Reference ID/Investigator# 22442

San Diego, California, United States

Site Reference ID/Investigator# 21061

Whittier, California, United States

Site Reference ID/Investigator# 16572

Yuba City, California, United States

Site Reference ID/Investigator# 26142

Coral Gables, Florida, United States

Site Reference ID/Investigator# 16567

Hudson, Florida, United States

Key Dates

Start Date

June 1, 2009

Primary Completion Date

April 1, 2010

Completion Date

May 1, 2010

Last Updated

June 6, 2018

Enrollment

ACTUAL participants

Conditions

Chronic Kidney DiseaseDiabetic Nephropathy

Interventions

Placebo for Atrasentan 0.2 mg/mL solution

DRUG

0.25 mg Atrasentan QD

DRUG

0.75 mg Atrasentan QD

DRUG

1.75 mg Atrasentan QD

DRUG

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NCT07241390

Atherosclerosis Cardiovascular DiseaseChronic Kidney Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Treated With Renin-Angiotensin System Inhibitors

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease

OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD

Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias