Clinical trial NCT01356849 (phase 2, status: completed)
Conditions: chronic kidney disease, diabetic nephropathy
ICD codes: I12.9, N18.9, I12.0, D63.1, N18.1, N18.5, I13.0, E10.21, E11.21, E13.21, E08.21, E09.21
Drugs: atrasentan, placebo
SMILES: CCCCN(CCCC)C(=O)CN1C[C@@H]([C@H]([C@@H]1C1=CC=C(OC)C=C1)C(O)=O)C1=CC2=C(OCO2)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patient is > or = 18 years old.

          -  Patient has Type 2 diabetes and has been treated with at least one anti hyperglycemic
             medication within the 12 months prior to the Screening Period.

          -  Patient is currently receiving an angiotensin converting enzyme inhibitor (ACEi) or
             Angiotensin II receptor blocker (ARB) (Renin Angiotensin System (RAS) inhibitor).

          -  For entry in the Run-in Period the patient must satisfy the following criteria based
             on the Screening laboratory values:

               -  Estimated glomerular filtration rate (eGFR) ≥ 30 and ≤ 75 mL/min/1.73m2 by
                  Epidemiology Collaboration (EPI) formula

               -  Urinary Albumin to Creatinine Ratio (UACR) > or = 300 and < or = 3500 mg/g as
                  determined by the geometric mean of the two morning void urine specimens obtained
                  at the Screening visit (UACR > or = 34 mg/mmol and < or = 396 mg/mmol)

               -  Serum albumin > or = 3.0 g/dL (30 g/L) - B-type Natriuretic Peptide (BNP) < or =
                  200 pg/mL (57.8 pmol/L) * Negative serum pregnancy test for female patients

               -  Systolic Blood Pressure (SBP) > or = 110 mmHg and < or = 180 mmHg

               -  Glucosylated hemoglobin A1c (HbA1c) < or = 12%

          -  For entry in the Treatment Period the patient 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 adjustments of dose

               -  Diuretic at any dose unless medically contraindicated (with the exception of loop
                  diuretics > or = 120 mg QD of furosemide or > or = 3.0 mg QD of bumetanide or >
                  or = 150 mg QD of ethacrynic acid or > or = 60 mg QD of torasemide)

               -  Urinary Albumin to Creatinine Ratio (UACR) > or = 200 and < or = 3500 mg/g as
                  determined by the median of the three morning void urine specimens obtained prior
                  to the Week -1 visit (UACR > or = 23 mg/mmol and < or = 396 mg/mmol)

               -  Systolic blood pressure (SBP) > or = 110 mmHg and < or = 160 mmHg

               -  Serum Potassium < or = 5.5 mEq/L (5.5 mmol/L)

               -  Negative serum pregnancy test for female patients

        Exclusion Criteria:

          -  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.

          -  Patient is receiving loop diuretics > or = 120 mg QD of furosemide or > or = 3.0 mg QD
             of bumetanide or > or = 150 mg QD of ethacrynic acid or > or = 60 mg QD of torasemide.

          -  Patient has a history of pulmonary edema.

          -  Patient has a history of pulmonary hypertension, or any lung diseases requiring oxygen
             therapy (i.e., chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis).

          -  Patient has a history of orthostatic hypotension within the past 6 months as defined
             by the presence of a supine-to-standing blood pressure decrease > or = 20 mmHg
             systolic or > or = 10 mmHg diastolic within 3 minutes of standing.