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

This study is not yet open for participant recruitment.

Verified by Novartis, March 2009

First Received: March 25, 2009 No Changes Posted

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00869856

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 III

MedlinePlus related topics: Anemia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

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
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

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

Contacts

Contact: Karsten Roth

+49 89 61 36 70 ext 0

Karsten.Roth@sandoz.com

Show 96 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Karsten Roth

Hexal AG

More Information

No publications provided

Responsible Party:	Sandoz Biopharmaceuticals Development ( Hexal AG )
Study ID Numbers:	HX575-304
Study First Received:	March 25, 2009
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00869856 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; Bulgaria: Bulgarian Drug Agency Ministry of Health; France: Afssaps - French Health Products Safety Agency; 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; Russia:Ministry of Health Care and Social Development of the Russian Federation; Russia:Federal State Institution; Serbia: Agency for Drugs/medicines and medical devices of Serbia; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Ukraine:State Pharmacological Center under the Ministry of Health of Ukraine

Keywords provided by Novartis:

Treatment associated with CRI

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic

Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Anemia
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009