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NCT01693029 · ClinicalTrials.gov registry record · Phase 3
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
A Phase 3 study of Anemia and Chronic Kidney Disease (CKD), sponsored by Sandoz.
- Completed
- Registry status
- Phase 3
- Development phase
- 435
- Enrollment target
- 20
- Study locations
NCT01693029 is a Phase 3 study of Anemia and Chronic Kidney Disease (CKD) that has completed, run by Sandoz. The registered enrollment target is 435 participants, roughly in line with the 422-participant average among 72 other Anemia trials with a reported enrollment target. The trial reports 20 study locations across 2 states.
The verdict
NCT01693029, a Phase 3 study of Anemia and Chronic Kidney Disease (CKD), has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 435 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.
Conditions Studied
Interventions
- DRUG HX575 epoetin alfa
- DRUG US-licensed epoetin alfa
Study Locations (20)
California
- North America Research Institute - Azusa
- Pegasus Dialysis, LLC - Bakersfield
- Central Nephrology Medical Group - Bakersfield
- California Institute of Renal Research - Chula Vista
- Renal Consultants Medical Group - Granada Hills
- Angel Kidney Care of Inglewood Dialysis Center - Inglewood
- California Institute of Renal Research - La Mesa
- Alliance Research Centers - Laguna Hills
- Academic Medical Research Institute - Los Angeles
- Ronald Reagan Medical Center, Department of Pharmaceutical Services, Drug Information Center - Los Angeles
- Tower Nephrology Medical Group - Los Angeles
- St Vincent Dialysis Center - Los Angeles
- Kidney Research Center - Lynwood
- Valley Renal Medical Group - Northridge
- Ontario Dialysis, Inc. - Ontario
- Apex Research of Riverside - Riverside
- Capital Nephrology Medical Group - Sacramento
- California Institute of Renal Research - San Diego
- La Jolla Clinical Research, Inc. - San Diego
Arizona
- Southwestern Kidney Institute - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 435 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01693029
The ClinicalTrials.gov registry entry for NCT01693029 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 435 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 422-participant average among 72 other Anemia trials with a reported enrollment target. The listed sponsor is Sandoz, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Anemia appearing as the primary indexed condition, and to 2 interventions - of which HX575 epoetin alfa is the first listed.
NCT01693029 reports 20 study locations spanning 2 distinct geographic areas - top geographies include California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01693029 about?
NCT01693029 is a clinical study titled "Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa". The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable...
What is the current status of trial NCT01693029?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 435 participants. The study started on 2012-09. Estimated completion is 2015-03.
What conditions does trial NCT01693029 study?
This clinical trial studies the following conditions: Anemia, Chronic Kidney Disease (CKD).
What interventions are being tested in trial NCT01693029?
The interventions under investigation include: HX575 epoetin alfa (DRUG), US-licensed epoetin alfa (DRUG).
Who is sponsoring clinical trial NCT01693029?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01693029 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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