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Summary

for people ages 18–85 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

Official 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

Details

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.

Keywords

Diabetic Nephropathy Diabetes Nephropathy Kidney Diseases Diabetic Nephropathies Atrasentan

Eligibility

You can join if…

Open to people ages 18–85

  • Subject has type 2 diabetes (including patients with latent autoimmune diabetes or insulin-treated patients without a history of diabetic ketoacidosis who also have a negative anti-glutamic acid decarboxylase test AND an elevated post-prandial serum C-peptide level) and has been treated with at least one anti-hyperglycemic medication and ACEi/or ARB (RAS inhibitor) for at least 4 weeks prior to the Screening S2 visit.
  • 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 [until the eGFR cap on subjects (approximately 300) with a baseline of > 60 mL/min/1.73 m2 is reached] and a urine albumin creatinine ratio (UACR) greater than or equal to 300 and less than 5,000 mg/g (greater than or equal to 34 mg/mmol and less than 565 mg/mmol);
  • Serum albumin greater than or equal to 2.5 g/dL (25 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 180 mmHg;
  • Serum Potassium greater than or equal to 3.5 mEq/L (3.5 mmol/L) and less than or equal to 6.0 mEq/L (6.0 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);
  • Subject must not have a weight change greater than or equal to 3 kg from the beginning of Enrichment to the end of the Enrichment Period and absolute serum BNP greater than or equal to 300 pg/mL (300 ng/L) at the last Enrichment visit;
  • Subject must not have an increase in serum creatinine greater than 0.5 mg/dL and greater than 20% increase from the beginning of Enrichment to the end of the Enrichment Period.

You CAN'T join if...

  • Subject has a history of severe peripheral edema or facial edema requiring diuretics unrelated to trauma or a history of myxedema in the prior 4 weeks to the initial Screening S1 visit.
  • Subject has a history of pulmonary hypertension, pulmonary fibrosis or any lung diseases requiring oxygen therapy (e.g., chronic obstructive pulmonary disease,emphysema).
  • 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).

Locations

  • San Francisco General Hospital/UCSF /ID# 105439
    San Francisco, California, 94110, United States
  • Sierra View Nephrology Inc /ID# 105576
    Porterville, California, 93257, United States
  • Capital Nephrology Medical Group /ID# 104900
    Sacramento, California, 95825, United States
  • Central Coast Nephrology /ID# 144669
    Salinas, California, 93901, United States
  • National Institute of Clinical Research /ID# 114816
    Bakersfield, California, 93309, United States
  • Sansum Clinic /ID# 96640
    Santa Barbara, California, 93110, United States
  • Sierra Nevada Nephrology Consultants /ID# 104910
    Reno, Nevada, 89511, United States
  • Facey Medical Foundation /ID# 96704
    Mission Hills, California, 91345, United States
  • Providence Clinical Research /ID# 102095
    North Hollywood, California, 91606, United States
  • California Renal Research Network, LLC /ID# 118555
    Glendale, California, 91204, United States
  • UCLA /Id# 145915
    Los Angeles, California, 90025, United States
  • Axis Clinical Trials /ID# 99397
    Los Angeles, California, 90036, United States
  • National Research Institute /ID# 104915
    Los Angeles, California, 90057, United States
  • Dr. Lakhi M. Sakhrani, Alhambra, CA. /ID# 99948
    Alhambra, California, 91801, United States
  • North America Research Institute /ID# 96605
    Azusa, California, 91702, United States
  • Academic Medical Research Institute /ID# 96596
    Los Angeles, California, 90022, United States
  • North America Research Institute /ID# 101579
    San Dimas, California, 91773, United States
  • Dr. Ambrose Y. Tsang, Downey, CA /ID# 105566
    Downey, California, 90241, United States
  • Rancho Los Amigos National Rehabilitation Center /ID# 147127
    Downey, California, 90242, United States
  • Mohammed Ismail, MD, Inc. /ID# 110415
    Paramount, California, 90723, United States
  • Lucita M. Cruz MD /ID# 105199
    Norwalk, California, 90650, United States
  • St. Jude Hospital /ID# 101476
    Fullerton, California, 92835, United States
  • VA Long Beach Healthcare System /ID# 123260
    Long Beach, California, 90822, United States
  • Inland Empire Liver Foundation /ID# 144258
    Rialto, California, 92377, United States
  • Diabetes Associates Medical Group /ID# 107200
    Orange, California, 92868, United States
  • APEX Research of Riverside /ID# 107455
    Riverside, California, 92505, United States
  • VA Loma Linda Healthcare System /ID# 148928
    Loma Linda, California, 92357, United States
  • Palm Research Center, Inc. /ID# 105501
    Las Vegas, Nevada, 89148, United States
  • Nevada Kidney Disease and Hypertension Center aka NKDHC /ID# 112900
    Las Vegas, Nevada, 89115, United States
  • Desert Medical Group, Inc. /ID# 96702
    Palm Springs, California, 92262, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT01858532
Phase
Phase 3
Lead Scientist
Sam James
Study Type
Interventional
Last Updated
October 20, 2017