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

Phase 3

Withdrawn

• Conditions: Anemia; Chronic Renal Insufficiency
• Interventions: Drug: HX575 solution for s.c. administration

• Registration Number: NCT00869856
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-25
• Study First Posted: 2009-03-26
• Study Start: 2009-04
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Systemic cyclosporine
• History of PRCA or aplastic anemia
• History of anti-EPO antibodies
• Uncontrolled hypertension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	HX575 solution for s.c. administration	HX575, EPO Hexal

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin level	36 weeks

Secondary Outcome Measures

Name	Time	Method
To document the safety and lack of immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration.	36 weeks

Trial Locations

Locations (18)

MHAT "Sveta Anna"; 🇧🇬 Varna, Bulgaria

MHAT "Dr. Tota Venkova"; 🇧🇬 Gabrovo, Bulgaria

Polyclinique de Bordeaux-Nord; 🇫🇷 Bordeaux, France

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Lübeck, Germany

Nierenzentrum Weinheim Kreiskrankenhaus Weinheim; 🇩🇪 Weinheim, Germany

Spitalul Clinic Judetean Timisoara; 🇷🇴 Timisoara, Romania

MHAT"Sveti Ivan Rilski"; 🇧🇬 Sofia, Bulgaria

Gesundheitszentrum Alzey Internistische Gemeinschaftspraxis; 🇩🇪 Slzrx, Germany

Spitalul Judetean de Urgenta Deva; 🇷🇴 Deva, Romania

MHAT Pazardzhik; 🇧🇬 Pazardzhik, Bulgaria

Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren; 🇫🇷 Limoges Cedex, France

Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel; 🇩🇪 Essen, Germany

KfH Nierenzentrum; 🇩🇪 Berlin, Germany

Hospital de Navarra; 🇪🇸 Pamplona, Spain

Spitalul Clinic de Nefrologie Dr. Carol Davila; 🇷🇴 Bucuresti, Romania

Spitalul Clinic Municipal "Dr. Gavril Curteanu"; 🇷🇴 Oradea, Romania

Spitalul Universitar de Urgenta Bucuresti; 🇷🇴 Bucuresti, Romania

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Spain