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
  Purpose

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 Intervention Phase
Anemia
Chronic Renal Insufficiency
Drug: HX575 solution for s.c. administration
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in hemoglobin level [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869856

Locations
Bulgaria
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
France
Polyclinique de Bordeaux-Nord
Bordeaux, France, 33077
Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren
Limoges Cedex, France, 87042
Germany
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
Romania
Spitalul Universitar de Urgenta Bucuresti
Bucuresti, Romania, 050098
Spitalul Clinic de Nefrologie Dr. Carol Davila
Bucuresti, Romania, 010731
Spitalul Judetean de Urgenta Deva
Deva, Romania, 330084
Spitalul Clinic Municipal "Dr. Gavril Curteanu"
Oradea, Romania, 410169
Spitalul Clinic Judetean Timisoara
Timisoara, Romania, 300736
Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Spain, 28222
Hospital de Navarra
Pamplona, Spain, 31008
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Karsten Roth Hexal AG
  More Information

No publications provided

Responsible Party: Hexal AG, Sandoz Biopharmaceuticals Development
ClinicalTrials.gov Identifier: NCT00869856     History of Changes
Other Study ID Numbers: HX575-304
Study First Received: March 25, 2009
Last Updated: August 20, 2009
Health Authority: Bulgaria: Bulgarian Drug Agency Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
Treatment associated with CRI

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014