Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006389

Trial Description

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Title

A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects With Type 2 Diabetes and Nephropathy SONAR: Study Of Diabetic Nephropathy With Atrasentan

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Trial Acronym

SONAR

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study is being conducted to evaluate the effects of Atrasentan on Renal Outcomes in
Subjects with Type 2 Diabetes and Nephropathy.

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Brief Summary in Scientific Language

The study objective is to evaluate the effect of atrasentan compared with placebo on time to
doubling of serum creatinine or the onset of end stage renal disease (ESRD) in subjects with
type 2 diabetes and nephropathy who are treated with the maximum tolerated labeled daily
dose (MTLDD) of a Renin Angiotensin System (RAS) inhibitor. In addition, the study will
assess the effects of atrasentan compared with placebo on cardiovascular morbidity and
mortality, urine albumin excretion, changes in estimated glomerular filtration rate (eGFR),
as well as on the impact on quality of life in subjects with type 2 diabetes and
nephropathy.

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Organizational Data

  •   DRKS00006389
  •   2014/11/18
  •   2013/05/17
  •   no
  •   [---]*
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Secondary IDs

  •   2012-005848-21 
  •   NCT01858532  (ClinicalTrials.gov)
  •   M11-352  (AbbVie)
  •   2012-005848-21 
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Health Condition or Problem studied

  •   Diabetic Nephropathy
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Interventions/Observational Groups

  •   Drug: Atrasentan
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Time to the first occurrence of a component of the composite renal endpoint.; time frame: Approximately 48 months.; Time to the first occurrence of a component of the composite renal endpoint: doubling of serum creatinine (confirmed by a 30-day serum creatinine) or the onset of end stage renal disease (needing chronic dialysis or renal transplantation or renal death).

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Secondary Outcome

- Change from baseline to Month 24 post-randomization visit on urine albumin creatinine ratio.; time frame: From Day 0 to 24 months.
- Time to a 30% estimated glomerular filtration rate reduction after 3 months post-randomization treatment.; time frame: Approximately 24 months.
- Time to cardio-renal composite endpoint: doubling of serum creatinine, end stage renal disease, cardiovascular death, nonfatal myocardial infarction, nonfatal stroke.; time frame: Approximately 48 months.
- Time to the cardiovascular composite endpoint: cardiovascular death, nonfatal myocardial infarction and nonfatal stroke.; time frame: Approximately 48 months.

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Austria
  •   Belgium
  •   Brazil
  •   Bulgaria
  •   Canada
  •   Chile
  •   Czech Republic
  •   Denmark
  •   Finland
  •   France
  •   Germany
  •   Greece
  •   Hong Kong
  •   Ireland
  •   Israel
  •   Italy
  •   Japan
  •   Korea, Republic of
  •   Malaysia
  •   Mexico
  •   Netherlands
  •   New Zealand
  •   Peru
  •   Poland
  •   Portugal
  •   Puerto Rico
  •   Romania
  •   Russian Federation
  •   Singapore
  •   Slovakia
  •   South Africa
  •   Spain
  •   Sweden
  •   Taiwan, Province of China
  •   Turkey
  •   Ukraine
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2013/01/31
  •   4148
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional Inclusion Criteria

- Subject has type 2 diabetes and has been treated with at least one anti-hyperglycemic
medication and angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor
blockers (ARB) (Renin Angiotensin System inhibitor) for at least 3 months prior to
the Screening Period.

- Glucosylated hemoglobin A1c (HbA1c) less than or equal to 12%.

- 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) 25 to 75 mL/min/1.73 m2 and a urine
albumin creatinine ratio (UACR) greater than or equal to 300 and less than 5,000
mg/g (The number of subjects with eGFR between 60 to 75 mL/min/1.73 m2 will be
capped to 10% of the total population);

- Serum albumin greater than or equal to 3.0 g/dL (30 g/L);

- Brain natriuretic peptide (BNP) less than or equal to 200 pg/mL (200 ng/L);

- Systolic blood pressure (SBP) greater than or equal to 110 and less than or
equal to 160 mmHg;

- Serum Potassium greater than or equal to 3.5 (3.5 mmol/L) and less than or equal
to 5.5 mEq/L (5.5 mmol/L);

- Subjects on a maximum tolerated labeled daily dose (MTLDD) of a RAS inhibitor
for greater than or equal to 4 weeks and on a diuretic at the time of screening
and who satisfy the above criteria may proceed to the last visit in Run-In
Period (R6);

- Subjects already on a MTLDD of a RAS inhibitor for greater than or equal to 4
weeks and not on a diuretic (unless medically contraindicated) at the time of
Screening will start with a diuretic and proceed to Run-In for at least 2 weeks.

- For entry into the Enrichment Period the subject must satisfy the following criteria
based on the last visit of the Run-In Period:

- RAS inhibitor at the MTLDD for the previous 4 weeks with no adjustments of the
dose;

- Subjects that were on a MTLDD RAS inhibitor and not on a diuretic (unless
medically contraindicated) at the time of Screening must have been in Run-In for
at least 2 weeks.

- For entry into the Double-Blind Treatment Period, the subject must satisfy the
following criteria based on the last visit of the Enrichment Period:

- RAS inhibitor at the MTLDD for the previous 6 weeks during the Enrichment Period
with no adjustments of the dose;

- Diuretic at any dose unless medically contraindicated or clinically intolerable
in the investigator's judgement (i.e., hypotension or hypokalemia);

- Weight change less than 3 kg and absolute serum BNP less than 300 pg/mL (300
ng/L) at Enrichment Week 6 from the beginning of Enrichment;

- Subjects must not have an acute kidney injury (AKI) event at the end of the
Enrichment period, as defined by an increase from baseline in serum Creatinine
greater than 0.5 mg/dL and greater than 20% increase at Enrichment Week 6 (visit
E5) from baseline.

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Exclusion Criteria

- Subject has a history of moderate or severe peripheral edema, pulmonary edema or
facial edema unrelated to trauma or a history of myxedema in the prior 6 months to
Screening.

- Subject has a history of pulmonary hypertension requiring oxygen therapy, and/or
endothelin receptor antagonist or phosphodiesterase therapy or any lung diseases
requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema,
pulmonary fibrosis).

- Subject has a documented diagnosis of heart failure, previous hospitalization for
heart failure or current or constellation of symptoms (dyspnea on exertion, pedal
edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart
failure, that was not explained by other causes, and for which there was a change in
medication or other management directed at heart failure.

- Subject has known non-diabetic kidney disease (other than kidney stones).

- Subject has a history of symptomatic hypotension within the last 6 months.

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Addresses

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    • AbbVie
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    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • AbbVie
    • Blai Coll, MD 
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    • Blai Coll, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.