KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)



Status:Active, not recruiting
Conditions:Iron Deficiency Anemia, Renal Impairment / Chronic Kidney Disease, Anemia, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:July 26, 2017
End Date:June 2020

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Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia

The objectives of this study are to assess the long-term efficacy and safety of different
dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects
with non-dialysis dependent chronic kidney disease (CKD).

This is a 48-week, randomized, open-label, multicenter clinical study comprised of 2 periods:
a 24-week Dose Titration Period, followed by a 24-week Dose Maintenance Period. The study
will consist of 12 scheduled clinic visits over a period of 48 weeks and additional visits as
needed.

Inclusion Criteria:

- Estimated glomerular filtration rate ≥20 mL/min and <60 mL/min

- Hgb ≥8.5 g/dL and ≤11.5 g/dL

- Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%

- Serum intact parathyroid hormone ≤600 pg/mL

Exclusion Criteria:

- Serum phosphate <3.0 mg/dL

- Intravenous (IV) iron administered within 4 weeks prior to Screening

- Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening

- Blood transfusion within 4 weeks prior to Screening
We found this trial at
29
sites
Gulfport, Mississippi 39501
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Asheville, North Carolina 28801
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Asheville, NC
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Augusta, GA
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Austin, Texas 78751
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Austin, TX
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Austin, Texas 78758
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Austin, TX
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Charlotte, North Carolina 28204
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Charlotte, NC
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9730 South Western Avenue
Chicago, Illinois 60643
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Chicago, IL
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Chula Vista, California 91910
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Chula Vista, CA
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Columbia, South Carolina 29203
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Columbia, SC
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Columbus, Georgia 31904
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Columbus, GA
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Denver, Colorado 80230
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Denver, CO
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6 Industrial Way West
Eatontown, New Jersey 07724
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Eatontown, NJ
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El Centro, California 92243
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El Centro, CA
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Great Neck, NY
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Greenville, North Carolina 27834
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Greenville, NC
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227 Memorial Drive
Jacksonville, North Carolina 28546
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Jacksonville, NC
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Kansas City, Missouri 64111
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Kansas City, MO
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607 South John Redditt Drive
Lufkin, Texas 75904
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Lufkin, TX
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Miami, Florida 33143
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Miami, FL
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Miami, FL
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Nashville, Tennessee 37205
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Nashville, TN
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New Bern, North Carolina 28562
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New Bern, NC
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Orangeburg, South Carolina 29118
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Orangeburg, SC
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Phoenix, AZ
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Poway, California 92064
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Poway, CA
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Reno, NV
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San Antonio, Texas 78215
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San Antonio, TX
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San Antonio, TX
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Wilmington, North Carolina 28401
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Wilmington, NC
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