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

Information source: Sandoz
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia; Chronic Renal Insufficiency

Intervention: HX575 solution for s.c. administration (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Sandoz

Official(s) and/or principal investigator(s):
Karsten Roth, Study Chair, Affiliation: Hexal AG

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in hemoglobin level

Secondary outcome: To document the safety and lack of immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Additional Information

Starting date: April 2009
Last updated: June 1, 2015

Page last updated: August 20, 2015

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