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

NCT ID: NCT00869856

Last Updated: 2015-06-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-08-31

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.

Conditions

Anemia; Chronic Renal Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

HX575, EPO Hexal

Group Type: EXPERIMENTAL

HX575 solution for s.c. administration

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karsten Roth

Role: STUDY_CHAIR

Hexal AG

Locations

MHAT "Dr. Tota Venkova"

Gabrovo, , Bulgaria

MHAT Pazardzhik

Pazardzhik, , Bulgaria

MHAT"Sveti Ivan Rilski"

Sofia, , Bulgaria

MHAT "Sveta Anna"

Varna, , Bulgaria

Polyclinique de Bordeaux-Nord

Bordeaux, , France

Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren

Limoges, , France

KfH Nierenzentrum

Bad König, , Germany

KfH Nierenzentrum

Berlin, , Germany

Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel

Essen, , Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, , Germany

Gesundheitszentrum Alzey Internistische Gemeinschaftspraxis

Slzrx, , Germany

Nierenzentrum Weinheim Kreiskrankenhaus Weinheim

Weinheim, , Germany

Spitalul Clinic de Nefrologie Dr. Carol Davila

Bucharest, , Romania

Spitalul Universitar de Urgenta Bucuresti

Bucharest, , Romania

Spitalul Judetean de Urgenta Deva

Deva, , Romania

Spitalul Clinic Municipal "Dr. Gavril Curteanu"

Oradea, , Romania

Spitalul Clinic Judetean Timisoara

Timișoara, , Romania

Hospital Universitario Puerta de Hierro

Majadahonda, , Spain

Hospital de Navarra

Pamplona, , Spain

Countries

Bulgaria; France; Germany; Romania; Spain

Other Identifiers

HX575-304

Identifier Type: -

Identifier Source: org_study_id