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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00869856
Recruitment Status : Withdrawn (investigation of adverse events in a related clinical study)
First Posted : March 26, 2009
Last Update Posted : June 2, 2015
Information provided by (Responsible Party):

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.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.

Condition or disease Intervention/treatment Phase
Anemia Chronic Renal Insufficiency Drug: HX575 solution for s.c. administration Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
HX575, EPO Hexal
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

Primary Outcome Measures :
  1. Change in hemoglobin level [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00869856

MHAT "Dr. Tota Venkova"
Gabrovo, Bulgaria, 5300
MHAT Pazardzhik
Pazardzhik, Bulgaria, 4400
MHAT"Sveti Ivan Rilski"
Sofia, Bulgaria, 1431
MHAT "Sveta Anna"
Varna, Bulgaria, 9000
Polyclinique de Bordeaux-Nord
Bordeaux, France, 33077
Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren
Limoges Cedex, France, 87042
KfH Nierenzentrum
Bad König, Germany, 64732
KfH Nierenzentrum
Berlin, Germany, 12045
Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel
Essen, Germany, 23538
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany, 68309
Gesundheitszentrum Alzey Internistische Gemeinschaftspraxis
Slzrx, Germany, 55232
Nierenzentrum Weinheim Kreiskrankenhaus Weinheim
Weinheim, Germany, 69469
Spitalul Clinic de Nefrologie Dr. Carol Davila
Bucuresti, Romania, 010731
Spitalul Universitar de Urgenta Bucuresti
Bucuresti, Romania, 050098
Spitalul Judetean de Urgenta Deva
Deva, Romania, 330084
Spitalul Clinic Municipal "Dr. Gavril Curteanu"
Oradea, Romania, 410169
Spitalul Clinic Judetean Timisoara
Timisoara, Romania, 300736
Hospital Universitario Puerta de Hierro
Majadahonda, Spain, 28222
Hospital de Navarra
Pamplona, Spain, 31008
Sponsors and Collaborators
Study Chair: Karsten Roth Hexal AG

Responsible Party: Sandoz Identifier: NCT00869856     History of Changes
Other Study ID Numbers: HX575-304
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: June 2015

Keywords provided by Sandoz:
Treatment associated with CRI

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Hematologic Diseases
Urologic Diseases
Epoetin Alfa