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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT00869856
• Date of registration: 25/03/2009
• Prospective Registration: Yes
• Primary sponsor: Sandoz
• Public title: Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP) SWEEP
• Scientific title: 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
• Date of first enrolment: April 2009
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00869856
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belgium, Bulgaria, France, Germany, Italy, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Ukraine

Contacts

• Name: Karsten Roth
• Affiliation: Hexal AG

Key inclusion & exclusion 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 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia

Chronic Renal Insufficiency

Intervention(s)

Drug: HX575 solution for s.c. administration

Primary Outcome(s)

Change in hemoglobin level [Time Frame: 36 weeks]

Secondary Outcome(s)

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]

Secondary ID(s)

HX575-304

Source(s) of Monetary Support

Please refer to primary and secondary sponsors