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HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)

NCT01576341 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 417

Last updated 2017-06-19

Study results available
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Summary

The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)

Conditions

Interventions

DRUG

HX575 epoetin alfa (Sandoz)

Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.

Sponsors & Collaborators

Principal Investigators

  • Sandoz Biopharmaceuticals · Sandoz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-10-31
Completion
2015-06-30

Countries

  • Germany
  • Italy
  • Poland
  • Romania
  • Russia
  • Turkey (Türkiye)
  • Ukraine

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 NCT01576341 on ClinicalTrials.gov