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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anemia, Chronic Renal Insufficiency

Intervention / Treatment
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* Drug: HX575 solution for s.c. administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>HX575, EPO Hexal | Drug: HX575 solution for s.c. administration<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin level |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment associated with CRI