This is an open-label, single-arm, baseline-controlled, multicenter efficacy and safety switch study involving 500 CKD subjects suffering from anemia and treated previously with a stable dose of ESA s.c. Correction of anemia will be maintained by s.c. administration of HX575 in two frequencies (i.e. qw and q2w), in order to maintain an Hb target range of 10.0-12.0 g/dL.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Containing different strengths of epoetin alfa (1 to 10 KIU), s.c. injection, 1x per week (qw) or 1x every two weeks (q2w), injection into abdomen or upper thigh
MHAT "Dr. Tota Venkova"
Gabrovo, Bulgaria
MHAT Pazardzhik
Pazardzhik, Bulgaria
Change in hemoglobin level
Time frame: 36 weeks
To document the safety and lack of immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration.
Time frame: 36 weeks
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MHAT"Sveti Ivan Rilski"
Sofia, Bulgaria
MHAT "Sveta Anna"
Varna, Bulgaria
Polyclinique de Bordeaux-Nord
Bordeaux, France
Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren
Limoges, France
KfH Nierenzentrum
Bad König, Germany
KfH Nierenzentrum
Berlin, Germany
Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel
Essen, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
...and 9 more locations