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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) (SWEEP)

Primary Purpose

Anemia, Chronic Renal Insufficiency

Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HX575 solution for s.c. administration
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Treatment associated with CRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MHAT "Dr. Tota Venkova"
  • MHAT Pazardzhik
  • MHAT"Sveti Ivan Rilski"
  • MHAT "Sveta Anna"
  • Polyclinique de Bordeaux-Nord
  • Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren
  • KfH Nierenzentrum
  • KfH Nierenzentrum
  • Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel
  • Universitätsklinikum Schleswig-Holstein
  • Gesundheitszentrum Alzey Internistische Gemeinschaftspraxis
  • Nierenzentrum Weinheim Kreiskrankenhaus Weinheim
  • Spitalul Clinic de Nefrologie Dr. Carol Davila
  • Spitalul Universitar de Urgenta Bucuresti
  • Spitalul Judetean de Urgenta Deva
  • Spitalul Clinic Municipal "Dr. Gavril Curteanu"
  • Spitalul Clinic Judetean Timisoara
  • Hospital Universitario Puerta de Hierro
  • Hospital de Navarra

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

HX575, EPO Hexal

Outcomes

Primary Outcome Measures

Change in hemoglobin level

Secondary Outcome Measures

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

Full Information

First Posted
March 25, 2009
Last Updated
June 1, 2015
Sponsor
Sandoz
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1. Study Identification

Unique Protocol Identification Number
NCT00869856
Brief Title
Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)
Acronym
SWEEP
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
investigation of adverse events in a related clinical study
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Chronic Renal Insufficiency
Keywords
Treatment associated with CRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
HX575, EPO Hexal
Intervention Type
Drug
Intervention Name(s)
HX575 solution for s.c. administration
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in hemoglobin level
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Roth
Organizational Affiliation
Hexal AG
Official's Role
Study Chair
Facility Information:
Facility Name
MHAT "Dr. Tota Venkova"
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
MHAT Pazardzhik
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
MHAT"Sveti Ivan Rilski"
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
MHAT "Sveta Anna"
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Polyclinique de Bordeaux-Nord
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Facility Name
Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
KfH Nierenzentrum
City
Bad König
ZIP/Postal Code
64732
Country
Germany
Facility Name
KfH Nierenzentrum
City
Berlin
ZIP/Postal Code
12045
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel
City
Essen
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Lübeck
ZIP/Postal Code
68309
Country
Germany
Facility Name
Gesundheitszentrum Alzey Internistische Gemeinschaftspraxis
City
Slzrx
ZIP/Postal Code
55232
Country
Germany
Facility Name
Nierenzentrum Weinheim Kreiskrankenhaus Weinheim
City
Weinheim
ZIP/Postal Code
69469
Country
Germany
Facility Name
Spitalul Clinic de Nefrologie Dr. Carol Davila
City
Bucuresti
ZIP/Postal Code
010731
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Bucuresti
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Spitalul Judetean de Urgenta Deva
City
Deva
ZIP/Postal Code
330084
Country
Romania
Facility Name
Spitalul Clinic Municipal "Dr. Gavril Curteanu"
City
Oradea
ZIP/Postal Code
410169
Country
Romania
Facility Name
Spitalul Clinic Judetean Timisoara
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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