Status:
COMPLETED
KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)
Lead Sponsor:
Keryx Biopharmaceuticals
Conditions:
Chronic Kidney Diseases
Iron Deficiency Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
This is a Phase 4, 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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2019
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT03236246
Start Date
August 15 2017
End Date
September 27 2019
Last Update
March 12 2021
Active Locations (28)
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1
Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC
Phoenix, Arizona, United States, 85032
2
California Institute of Renal Research
Chula Vista, California, United States, 91910
3
California Institute of Renal Research
El Centro, California, United States, 92243
4
California Institute of Renal Research
Poway, California, United States, 92064