Completed PHASE4 INTERVENTIONAL 1-arm NCT00632125

Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v. (EPO-PASS)

Post-authorization Safety Study to Prospectively Monitor the Incidence of Relevant Drug-related Adverse Events and EPO-related Lack of Efficacy Among CKD Subjects Receiving HX575 Recombinant Human Erythropoietin Alfa i.v.

Sponsor: Hexal AG

Conditions Chronic Kidney Disease

Interventions HX575 recombinant human erythropoietin alfa

Updated 7 times since 2017 Last updated: Jul 10, 2017 Started: Jul 31, 2008 Primary completion: Mar 31, 2010 Completion: Sep 30, 2010

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Chronic Kidney Disease, this trial is completed. The trial is conducted by Hexal AG and has accumulated 7 data snapshots since 2008. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE4
Sep 2024 — Sep 2025 [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
Jan 2021 — Jul 2024 [monthly]

Completed PHASE4
Jun 2018 — Jan 2021 [monthly]

Completed PHASE4

▶ Show 2 earlier versions

Aug 2017 — Jun 2018 [monthly]

Completed PHASE4
Jan 2017 — Aug 2017 [monthly]

Completed PHASE4

First recorded

Jul 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Hexal AG
Sandoz

Data source: Sandoz

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ancona, Italy , Andernach, Germany , Anzio, Italy , Arad, Romania , Aschaffenburg, Germany , Ascoli Piceno, Italy , Bad Ischl, Austria , Baunatal, Germany , Bayreuth, Germany , Berlin, Germany and 93 more locations