MedTrace Logo

Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.

NCT00632125 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1695

Last updated 2017-07-11

Study results available
· View outcomes & findings →

Summary

Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa i.v.

Conditions

Interventions

DRUG

HX575 recombinant human erythropoietin alfa

HX575 epoetin alfa i.v. will be administered according to the SmPC

Sponsors & Collaborators

  • Hexal AG

    collaborator INDUSTRY

  • Sandoz

    lead INDUSTRY

Principal Investigators

  • Karsten Roth, Dr · Hexal AG

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-03-31
Completion
2010-09-30

Countries

  • Austria
  • Bulgaria
  • France
  • Germany
  • Italy
  • North Macedonia
  • Poland
  • Romania
  • Russia
  • 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 NCT00632125 on ClinicalTrials.gov