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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)

NCT00869856 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-06-02

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Karsten Roth · Hexal AG

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Bulgaria
  • France
  • Germany
  • Romania
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00869856 on ClinicalTrials.gov