| Outcome Measures: |
Primary: Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5, Proportion of patients achieving a hemoglobin change of at least 0.5 g/dL during the period from Baseline to Week 5, 35 days | Secondary: Incidence of Treatment Emergent Adverse Events, Incidence of Treatment Emergent Adverse Events, 49 days|Incidence of adverse events of special interest (AESI), Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity), 49 days | Other: Area Under the Curve (AUC), Pharmacokinetic parameter: Area Under the Curve (AUC), 35 days|Clearance, Pharmacokinetic parameter: clearance, 35 days|Distribution and elimination half-lives, Pharmacokinetic parameter: distribution and elimination half-lives, 35 days
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| Locations: |
Memorial Healthcare System, Hollywood, Florida, 33021, United States|Wayne State University, Detroit, Michigan, 48201, United States|Children's Mercy Hospital, Kansas City, Missouri, 64108, United States|Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM), Bronx, New York, 10467, United States|The Feinstein Institute Medical Research Organization of Northwell Health, Inc., Lake Success, New York, 11042, United States|Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH), New York, New York, 10029, United States|Akron Nephrology Associates, Inc., Akron, Ohio, 44302, United States|West Virginia University, Morgantown, West Virginia, 26506, United States|Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika, Budapest, Hungary|University Of Szeged, Szeged, Hungary|Hospital of Lithuanian University of Health Sciences Kauno klinikos, Kaunas, Lithuania|Klaipeda Children's Hospital, Klaipėda, Lithuania|Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital), Vilnius, Lithuania|Instituto Mexicano De Trasplantes S.C, Cuernavaca, Mexico|JM Research, SC, Cuernavaca, Mexico|Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Mexico|Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics), Mexico City, Mexico|Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku, Białystok, Poland|Specjalistyczne Gabinety Sp. z o.o, Kraków, Poland|University Children Hospital, Kraków, Poland|Polish Mother's Memorial Hospital Research Institute, Łódź, Poland
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