Chronic Kidney DiseasePhase 2NCT01399580
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
A Phase 2 study testing Atrasentan in people with Chronic Kidney Disease and Diabetic Nephropathy, run by AbbVie (prior sponsor, Abbott) at 28 sites in United States.
Trial summary
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… 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
- 48 participants
- Where
- 28 sitesUnited States
- Study dates
- Aug 2011to Sep 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
- Subject is greater than or equal to 18 years old.
- 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.
- Subject is currently receiving an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II receptor blocker (ARB) (Renin Angiotensin System (RAS) inhibitor).
- 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.
- 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
Show all 19Show fewer
- 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%
- 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
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.
- 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.
- Subject has a history of pulmonary edema.
- Subject has a history of pulmonary hypertension, or any lung diseases requiring oxygen therapy (i.e., chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis).
- 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.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Site Reference ID/Investigator# 64023
Albany, New York, 12206
Site Reference ID/Investigator# 68986
Augusta, Georgia, 30901
Site Reference ID/Investigator# 56927
Azusa, California, 91702
Site Reference ID/Investigator# 70793
Azusa, California, 91702
Site Reference ID/Investigator# 54129
Baton Rouge, Louisiana, 70808
Site Reference ID/Investigator# 54123
Bethlehem, Pennsylvania, 18017
Site Reference ID/Investigator# 56924
Boynton Beach, Florida, 33472
Site Reference ID/Investigator# 54132
Chattanooga, Tennessee, 37408
Site Reference ID/Investigator# 56644
Chicago, Illinois, 60611
Site Reference ID/Investigator# 64027
Chula Vista, California, 91910
Site Reference ID/Investigator# 54120
Concord, California, 94520
Site Reference ID/Investigator# 54108
Dallas, Texas, 75231
Site Reference ID/Investigator# 54121
Denver, Colorado, 80209
Site Reference ID/Investigator# 54164
Fargo, North Dakota, 58103
Site Reference ID/Investigator# 55543
Flushing, New York, 11355
Site Reference ID/Investigator# 54126
Greenville, Texas, 75402
Site Reference ID/Investigator# 56642
Hollywood, Florida, 33021
Site Reference ID/Investigator# 58153
Houston, Texas, 77024
Site Reference ID/Investigator# 54110
Houston, Texas, 77099
Site Reference ID/Investigator# 64026
La Mesa, California, 91942
Site Reference ID/Investigator# 70173
Los Angeles, California, 90048
Site Reference ID/Investigator# 54116
North Richland Hills, Texas, 76180
Site Reference ID/Investigator# 58144
Phoenix, Arizona, 85032
Site Reference ID/Investigator# 61742
Pittsburgh, Pennsylvania, 15224
Site Reference ID/Investigator# 68982
Pontiac, Michigan, 48341
Site Reference ID/Investigator# 54173
Silverdale, Washington, 98383
Site Reference ID/Investigator# 71034
Tempe, Arizona, 85284
Site Reference ID/Investigator# 58147
Willoughby Hills, Ohio, 44094
About this study
Official title: 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.
- Conditions
- Chronic Kidney Disease, Diabetic Nephropathy
- Being tested
- Atrasentan, Placebo
- Keywords
- endothelin receptor antagonists
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetic Nephropathies
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 8 weeks during the treatment period.
PlaceboDrug
Subjects will take two tablets daily of placebo QD for 8 weeks during the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Placebo QD | Placebo comparator | Not described Receives: Drug: Placebo |
| Group B - Low dose Atrasentan QD | Active comparator | Not described Receives: Drug: Atrasentan |
| Group C - High dose Atrasentan QD | Active comparator | Not described Receives: Drug: Atrasentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to each post-baseline visit up to Week 8 in log-transformed Urinary Albumin to Creatinine Ratio (UACR)
Measured: Every two weeks for 8 weeks
Secondary outcomes (2)
Change from baseline to each post baseline measure for estimated glomerular filtration rate (eGFR)
Measured: Every two weeks for 8 weeks
The change from baseline to each post-baseline assessment of thoracic bioimpedance
Measured: Treatment Day 1, Week 1, 2, 4, 6, 8 and 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2012
- Study completionSep 2012
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Blai Coll, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399580
- Sponsor's protocol ID
- M12-830
- Status last verified
- Sep 2013
- First submitted
- 20 Jul 2011
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01399580
- Acronym / sponsor ID
- M12-830
- Conditions
- Chronic Kidney Disease, Diabetic Nephropathy
- Keywords
- endothelin receptor antagonists
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Jul 2011 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - Placebo QD | Placebo comparator | Drug: Placebo |
| Group B - Low dose Atrasentan QD | Active comparator | Drug: Atrasentan |
| Group C - High dose Atrasentan QD | Active comparator | Drug: Atrasentan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subject is greater than or equal to 18 years old.
- 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.
- Subject is currently receiving an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II receptor blocker (ARB) (Renin Angiotensin System (RAS) inhibitor).
- 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.
- For entry into the Run-in Period the subject must satisfy the following criteria based on the Screening laboratory values:
Key exclusion criteria (5 listed)
- 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.
- 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.
- Subject has a history of pulmonary edema.
- Subject has a history of pulmonary hypertension, or any lung diseases requiring oxygen therapy (i.e., chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis).
- 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.
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 |
|---|---|---|
| AtrasentanAlso: ABT-627Subjects will take two tablets daily of either low dose Atrasentan QD or high dose Atrasentan QD for 8 weeks during the treatment period. | Drug | Group B - Low dose Atrasentan QD, Group C - High dose Atrasentan QD |
| PlaceboSubjects will take two tablets daily of placebo QD for 8 weeks during the treatment period. | Drug | Group A - Placebo QD |
Primary outcome
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
2 secondary outcomes
Change from baseline to each post baseline measure for estimated glomerular filtration rate (eGFR)
Time frame: 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
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 25 Oct 2013.
- Derived from this study: PubMed 28756065Lin 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.
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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.
Blai Coll, MD study director
AbbVie
28 sites in 1 country: see every site and its status.
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 28 sites in United States.
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 19 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 25 Oct 2013. 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. 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 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). 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 NCT01399580, 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 25 Oct 2013.