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

This study has been terminated.
(investigation of adverse events in a related clinical study)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00869856
First received: March 25, 2009
Last updated: August 20, 2009
Last verified: August 2009

March 25, 2009
August 20, 2009
April 2009
August 2009   (final data collection date for primary outcome measure)
Change in hemoglobin level [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00869856 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anemia
  • Chronic Renal Insufficiency
Drug: HX575 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
Experimental: 1
HX575, EPO Hexal
Intervention: Drug: HX575 solution for s.c. administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
500
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Spain,   Bulgaria,   Romania
 
NCT00869856
HX575-304
Yes
Hexal AG, Sandoz Biopharmaceuticals Development
Novartis
Not Provided
Study Chair: Karsten Roth Hexal AG
Novartis
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP