A Phase 3 interventional study of HX575 solution for s.c. administration in Anemia and Chronic Renal Insufficiency, sponsored by Sandoz. Withdrawn at 19 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-02.
Sponsored by Sandoz · Phase 3, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
Browse Kidney Diseases studies →Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HX575, EPO Hexal
Drug: HX575 solution for s.c. administration
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
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
This study is withdrawn, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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