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 - SWEEP Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002696-27-BE

Enrollment

500

Registered

2008-11-13

Start date

2008-12-04

Completion date

Unknown

Last updated

2014-10-07

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

Conditions

Anemia associated with chronic kidney disease in pre-dialysis and dialysis subjects MedDRA version: 9.1 Level: LLT Classification code 10009120 Term: Chronic renal failure anaemia

Interventions

Trade Name: Binocrit (referred in the protocol to as HX575) Product Name: HX575 epoetin alfa (registered as Binocrit®) Product Code: HX575 Pharmaceutical Form: Solution for injection INN or Proposed I

Eligibility

Sex/Gender

All

Inclusion criteria

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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Systemic cyclosporine • History of PRCA or aplastic anemia • History of anti-EPO antibodies • Uncontrolled hypertension

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that HX575 administered s.c. qw and q2w maintains the correction of anemia associated with CKD.;Secondary Objective: To document the safety and immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration.;Primary end point(s): Successful 1:1 conversion from ESA to weekly HX575, and from weekly HX575 to fortnightly HX575, as assessed by the mean absolute change in Hb levels.	—

Measure

Time frame

Main Objective: To demonstrate that HX575 administered s.c. qw and q2w maintains the correction of anemia associated with CKD.;Secondary Objective: To document the safety and immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration.;Primary end point(s): Successful 1:1 conversion from ESA to weekly HX575, and from weekly HX575 to fortnightly HX575, as assessed by the mean absolute change in Hb levels.

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Countries

Belgium, France, Germany, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026