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

Inclusion Criteria:

- 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.

- 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.

Exclusion Criteria:

- 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.

- 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