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

June 1, 2015 updated by: Sandoz

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
HX575, EPO Hexal
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in hemoglobin level
Time Frame: 36 weeks
36 weeks

Secondary Outcome Measures

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.
Time Frame: 36 weeks
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Investigators

  • Study Chair: Karsten Roth, Hexal AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (Estimate)

March 26, 2009

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HX575-304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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