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

NCT00869856 | Withdrawn Phase 3 DMC

• 1 other identifier: HX575-304
• Study Type: interventional
• Target: N/A
• Locations: 5 countries
• Sites: 19

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

Keywords

Treatment associated with CRI

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin level

  36 weeks

Secondary Outcomes (1)

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

  36 weeks

Study Arms (1)

1

EXPERIMENTAL

HX575, EPO Hexal

Drug: HX575 solution for s.c. administration

Interventions

HX575 solution for s.c. administration 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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sandoz: lead

Study Sites (19)

MHAT "Dr. Tota Venkova"

Gabrovo, 5300, Bulgaria

Location

MHAT Pazardzhik

Pazardzhik, 4400, Bulgaria

Location

MHAT"Sveti Ivan Rilski"

Sofia, 1431, Bulgaria

Location

MHAT "Sveta Anna"

Varna, 9000, Bulgaria

Location

Polyclinique de Bordeaux-Nord

Bordeaux, 33077, France

Location

Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren

Limoges, 87042, France

Location

KfH Nierenzentrum

Bad König, 64732, Germany

Location

KfH Nierenzentrum

Berlin, 12045, Germany

Location

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

Essen, 23538, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, 68309, Germany

Location

Gesundheitszentrum Alzey Internistische Gemeinschaftspraxis

Slzrx, 55232, Germany

Location

Nierenzentrum Weinheim Kreiskrankenhaus Weinheim

Weinheim, 69469, Germany

Location

Spitalul Clinic de Nefrologie Dr. Carol Davila

Bucharest, 010731, Romania

Location

Spitalul Universitar de Urgenta Bucuresti

Bucharest, 050098, Romania

Location

Spitalul Judetean de Urgenta Deva

Deva, 330084, Romania

Location

Spitalul Clinic Municipal "Dr. Gavril Curteanu"

Oradea, 410169, Romania

Location

Spitalul Clinic Judetean Timisoara

Timișoara, 300736, Romania

Location

Hospital Universitario Puerta de Hierro

Majadahonda, 28222, Spain

Location

Hospital de Navarra

Pamplona, 31008, Spain

Location

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karsten Roth

  Hexal AG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 2, 2015

Record last verified: 2015-06

Locations

RO (5); BU (4); ES (2); DE (6); FR (2)