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

Sponsors

Lead sponsor: Sandoz

Source Sandoz
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.

Overall Status Withdrawn
Start Date April 2009
Completion Date August 2009
Primary Completion Date August 2009
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in hemoglobin level 36 weeks
Secondary Outcome
Measure Time Frame
To document the safety and lack of immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration. 36 weeks
Condition
Intervention

Intervention type: Drug

Intervention name: HX575 solution for s.c. administration

Description: 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

Arm group label: 1

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

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

Bulgaria

France

Germany

Romania

Spain

Verification Date

June 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: 1

Arm group type: Experimental

Description: HX575, EPO Hexal

Acronym SWEEP
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov