Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)

An Open Label, Single-arm, Baseline-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 Administered Once a Week (qw) and Once Every Two Weeks (q2w) in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Subjects

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00869856

Acronym

SWEEP

Enrollment

Registered

2009-03-26

Start date

2009-04-30

Completion date

2009-08-31

Last updated

2015-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Chronic Renal Insufficiency

Keywords

Treatment associated with CRI

Brief summary

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.

Interventions

DRUGHX575 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in hemoglobin level	36 weeks

Secondary

Measure	Time frame
To document the safety and lack of immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration.	36 weeks

Countries

Bulgaria, France, Germany, Romania, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026