Chronic Kidney DiseasePhase 2NCT00920764

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

A Phase 2 study testing 0.25 mg Atrasentan QD, 0.75 mg Atrasentan QD and 1.75 mg Atrasentan QD in people with Chronic Kidney Disease and Diabetic Nephropathy, run by AbbVie (prior sponsor, Abbott) at 28 sites in 2 countries.

Completed

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

Official record

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Trial 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. 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?: 0.25 mg Atrasentan QD, 0.75 mg Atrasentan QD and 1.75 mg Atrasentan QD
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 92 participants
Where: 28 sitesin 2 countries
Study dates: Jun 2009to May 2010
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

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.

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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.
d.HbA1c <= 10%.
e.Pro-BNP <= 500pg/mL.
f.Negative urine pregnancy test for female subjects.

Who cannot join

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.

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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.
11.Subject has a history of secondary hypertension (i.e., renal artery stenosis, primary aldosteronism or pheochromocytoma).
12.Subject has poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and or diastolic blood pressure ≥ 90 mmHg) or hypotension (systolic blood pressure <= 90 mmHg).
13.Subject has significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy less than 1 year.
14.Subject is expected to receive an increased dose of current RAAS inhibitor (ACEi, ARB, renin or aldosterone inhibitor) during the course of the study. Conversions from one product to another (e.g., ACEi to ARB) must be at equivalent doses.
15.Subject has clinically significant coronary artery disease (CAD) within 3 months prior to the Screening Period, defined as one of the following:
Hospitalization for MI or unstable angina; or
New onset angina with positive functional study or coronary angiogram revealing stenosis; or
Coronary revascularization procedure.
16.Subject has a history of viral or bacterial infection within 4 weeks of Screening or HIV infection.
17.Subject has scheduled or planned surgery with general anesthesia within 12 weeks of Screening Visit.
18.Subject has a history of drug or alcohol abuse within 6 months prior to the Screening Visit.
19.Subject has evidence of poor compliance with diet or medication that may interfere, in the Investigator's opinion, with adherence to the protocol.
20.Subject has received any investigational drug within 30 days prior to study drug administration.
21.For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive atrasentan oral solution or is put at risk by study procedures

Trial locations and contacts

28 sites in 2 countries.

Country

City, postcode or hospital

28 sites in 2 countries

United States24 sites

Site Reference ID/Investigator# 25043
Azusa, California, 91702
Site Reference ID/Investigator# 19383
Bethlehem, Pennsylvania, 18017
Site Reference ID/Investigator# 20221
Buffalo, New York, 14215
Site Reference ID/Investigator# 26142
Coral Gables, Florida, 33134
Site Reference ID/Investigator# 24542
Fairfax, Virginia, 22030
Site Reference ID/Investigator# 16576
Greenville, North Carolina, 27834
Site Reference ID/Investigator# 16567
Hudson, Florida, 34667
Site Reference ID/Investigator# 23308
Los Angeles, California, 90022
Site Reference ID/Investigator# 25430
Los Angeles, California, 90048
Site Reference ID/Investigator# 16573
Morehead City, North Carolina, 28557
Site Reference ID/Investigator# 16574
Omaha, Nebraska, 68131
Site Reference ID/Investigator# 26365
Orangeburg, South Carolina, 29115
Site Reference ID/Investigator# 16577
Pembroke Pines, Florida, 33028
Site Reference ID/Investigator# 25242
Pembroke Pines, Florida, 33028
Site Reference ID/Investigator# 16569
Rockville, Maryland, 20852
Site Reference ID/Investigator# 16571
San Antonio, Texas, 78229-4801
Site Reference ID/Investigator# 16566
San Antonio, Texas, 78229
Site Reference ID/Investigator# 19384
San Antonio, Texas, 78229
Site Reference ID/Investigator# 20421
San Diego, California, 92123
Site Reference ID/Investigator# 22442
San Diego, California, 92123
Site Reference ID/Investigator# 26143
Statesville, North Carolina, 28625
Site Reference ID/Investigator# 19386
Tempe, Arizona, 85284
Site Reference ID/Investigator# 21061
Whittier, California, 90603
Site Reference ID/Investigator# 16572
Yuba City, California, 95991

Other trials in United States

Puerto Rico4 sites

Site Reference ID/Investigator# 16564
Las Piedras, 00771
Site Reference ID/Investigator# 19381
Ponce, 00717
Site Reference ID/Investigator# 16563
San Juan, 00918
Site Reference ID/Investigator# 16562
San Juan, 00936-5067

Other trials in Puerto Rico

About this study

Official title: 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

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.

Conditions: Chronic Kidney Disease, Diabetic Nephropathy
Being tested: Placebo for Atrasentan 0.2 mg/mL solution, 0.25 mg Atrasentan QD, 0.75 mg Atrasentan QD, 1.75 mg Atrasentan QD
Keywords: CKD Stages 3&4, Endothelin antagonist, 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.

Placebo for Atrasentan 0.2 mg/mL solutionDrug
10 mL oral solution, daily, 8 weeks
0.25 mg Atrasentan QDDrug
10 mL oral solution, daily, 8 weeks
0.75 mg Atrasentan QDDrug
10 mL oral solution, daily, 8 weeks
1.75 mg Atrasentan QDDrug
10 mL oral solution, daily, 8 weeks

Study groups in NCT00920764
Study group	Role	What they receive
A	Active comparator	Not described Receives: Drug: 1.75 mg Atrasentan QD
B	Active comparator	Not described Receives: Drug: 0.25 mg Atrasentan QD
C	Active comparator	Not described Receives: Drug: 0.75 mg Atrasentan QD
D	Placebo comparator	Not described Receives: Drug: Placebo for Atrasentan 0.2 mg/mL solution

What is being measured

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

Mean change from baseline to each post-baseline observation on UACR over the course of treatment period versus standard of care
Measured: Week 8 visit or final assessment

Secondary outcomes (4)

Proportion of subjects achieving at least a 25% reduction in final UACR levels from baseline
Measured: Week 8 visit or final assessment
Proportion of subjects achieving at least a 40% reduction in final UACR levels from baseline
Measured: Week 8 visit or final assessment
Change from baseline to the final value in UACR, estimated glomerular filtration rate (eGFR), Neutrophil Gelatinase-Associated Lipocalin (NGAL)
Measured: Week 8 visit or final assessment
Change from baseline to each weekly measurement in NGAL
Measured: Week 8 visit or final assessment

Timeline

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

Jun 2009May 2010

First posted15 Jun 2009 (estimated)
Study startJun 2009
Primary completionApr 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00920764
Sponsor's protocol ID: M10-815
Status last verified: Jan 2013
First submitted: 11 Jun 2009
Last updated: 6 Jun 2018
Results posted: No
Data monitoring committee: No

Publications

Perez-Gomez MV, Sanchez-Nino MD, Sanz AB, Martin-Cleary C, Ruiz-Ortega M, Egido J, Navarro-Gonzalez JF, Ortiz A, Fernandez-Fernandez B. Horizon 2020 in Diabetic Kidney Disease: The Clinical Trial Pipeline for Add-On Therapies on Top of Renin Angiotensin System Blockade. J Clin Med. 2015 Jun 18;4(6):1325-47. doi: 10.3390/jcm4061325.
PubMed 26239562

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00920764
Acronym / sponsor ID: M10-815
Conditions: Chronic Kidney Disease, Diabetic Nephropathy
Keywords: CKD Stages 3&4, Endothelin antagonist, Proteinuria
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Apr 2010 (actual)
Study completion: May 2010 (actual)
First posted: 15 Jun 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
A	Active comparator	Drug: 1.75 mg Atrasentan QD
B	Active comparator	Drug: 0.25 mg Atrasentan QD
C	Active comparator	Drug: 0.75 mg Atrasentan QD
D	Placebo comparator	Drug: Placebo for Atrasentan 0.2 mg/mL solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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.

Key exclusion criteria (24 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo for Atrasentan 0.2 mg/mL solution10 mL oral solution, daily, 8 weeks	Drug	D
0.25 mg Atrasentan QD10 mL oral solution, daily, 8 weeks	Drug	B
0.75 mg Atrasentan QD10 mL oral solution, daily, 8 weeks	Drug	C
1.75 mg Atrasentan QD10 mL oral solution, daily, 8 weeks	Drug	A

Primary outcome

Mean change from baseline to each post-baseline observation on UACR over the course of treatment period versus standard of care
Time frame: Week 8 visit or final assessment

4 secondary outcomes

Proportion of subjects achieving at least a 25% reduction in final UACR levels from baseline
Time frame: Week 8 visit or final assessment
Proportion of subjects achieving at least a 40% reduction in final UACR levels from baseline
Time frame: Week 8 visit or final assessment
Change from baseline to the final value in UACR, estimated glomerular filtration rate (eGFR), Neutrophil Gelatinase-Associated Lipocalin (NGAL)
Time frame: Week 8 visit or final assessment
Change from baseline to each weekly measurement in NGAL
Time frame: Week 8 visit or final assessment

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
Background: PubMed 26239562Perez-Gomez MV, Sanchez-Nino MD, Sanz AB, Martin-Cleary C, Ruiz-Ortega M, Egido J, Navarro-Gonzalez JF, Ortiz A, Fernandez-Fernandez B. Horizon 2020 in Diabetic Kidney Disease: The Clinical Trial Pipeline for Add-On Therapies on Top of Renin Angiotensin System Blockade. J Clin Med. 2015 Jun 18;4(6):1325-47. doi: 10.3390/jcm4061325.

Related trials for Chronic Kidney Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dennis Andress study director

AbbVie

28 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 24 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Puerto Rico. 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?

Mean change from baseline to each post-baseline observation on UACR over the course of treatment period versus standard of care (time frame: Week 8 visit or final assessment). 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 NCT00920764, which also lists 1 linked publication.

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 6 Jun 2018.