Clinical Study Protocol Abbvie M11-352

  • STATUS
    Recruiting
  • sponsor
    AbbVie Inc.
Updated on 25 March 2021

Summary

Clinical Study Protocol Abbvie M11-352

Description

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
Condition Diabetes Mellitus, Type 2
Clinical Study IdentifierTX146007
SponsorAbbVie Inc.
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is 18 – 85 years of age at the initial Screening S1 visit
Subject has type 2 diabetes (including patients with latent autoimmune diabetes or insulin-treated patients without a history of diabetic ketoacidosis medication and ACEi/or ARB (RAS inhibitor) for at least 4 weeks prior to the Screening S2 visit
Subjects on a MTLDD of a RAS inhibitor for = 4 weeks and on a diuretic at the time of screening, (unless medically contra-indicated)
If male, subject must be surgically sterile or practicing at least two of the following methods of contraception, from initial study drug administration through 90 days after last dose of study drug unless subject's partner(s) is post-menopausal or has been surgically sterilized: Partner(s) using an IUD; Partner(s) using hormonal contraceptives (oral, vaginal, parenteral or transdermal); Subject and/or partner(s) using barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring with spermicidal jellies or creams); Total abstinence from sexual intercourse as the preferred life style of the subject; periodic abstinence is not acceptable
If male, subject must agree not to donate sperm from initial study drug administration through 90 days after the last dose of study drug

Exclusion Criteria

Exclusion Criteria
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 known non-diabetic kidney disease (other than kidney stones)
Subject has a history of an allergic reaction or significant sensitivity to Atrasentan (or its excipients) or similar compounds
Subject is currently receiving rosiglitazone, moxonidine, aldosterone blockers, aliskiren or a combination of ACEi and ARB
Subject is a premenopausal woman defined as (for study purposes) any female subject with a menses in the past 2 years. For women who are < 50 years old, serum FSH must be greater than 35 IU/L. Women who are surgically sterile or have a history of hysterectomy may not be premenopausal
Subject has type 1 diabetes
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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