Status:
WITHDRAWN
Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)
Lead Sponsor:
Sandoz
Conditions:
Anemia
Chronic Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- Systemic cyclosporine
- History of PRCA or aplastic anemia
- History of anti-EPO antibodies
- Uncontrolled hypertension
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00869856
Start Date
April 1 2009
End Date
August 1 2009
Last Update
June 2 2015
Active Locations (19)
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1
MHAT "Dr. Tota Venkova"
Gabrovo, Bulgaria, 5300
2
MHAT Pazardzhik
Pazardzhik, Bulgaria, 4400
3
MHAT"Sveti Ivan Rilski"
Sofia, Bulgaria, 1431
4
MHAT "Sveta Anna"
Varna, Bulgaria, 9000