Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)
Status and phase
Withdrawn
Phase 3
Conditions
Anemia
Chronic Renal Insufficiency
Treatments
Drug: HX575 solution for s.c. administration
Details and patient eligibility
About
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.
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Male and female CKD subjects with or without dialysis treatment
- Age > 18 years
- Subjects under documented stable maintenance therapy with ESA, s.c. at least once per week and in accordance with the relevant SmPC, for at least 3 months with a total weekly dose of ≤ 300 IU/kg/week
- Subjects with controlled symptomatic anemia, defined as mean Hb level between 10.0 g/dL and 12.0 g/dL, based on four Hb measurements during the four-week baseline period
- Adequate iron status, serum ferritin ≥ 100 µg/L or transferrin saturation ≥ 20%
- Confirmed negative anti-EPO antibody assay from sample taken at screening visit -4
Exclusion criteria
- Systemic cyclosporine
- History of PRCA or aplastic anemia
- History of anti-EPO antibodies
- Uncontrolled hypertension
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
0 participants in 1 patient group
1
Experimental group
Description:
HX575, EPO Hexal
Treatment:
Drug: HX575 solution for s.c. administration
Trial contacts and locations
19
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Data sourced from clinicaltrials.gov
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