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COMPLETED Phase 3

Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa

NCT01693029 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 435 participants
Start Date 2012-09
Est. Completion 2015-03
Phase Phase 3

Sponsor

Sandoz

11 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 435 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sandoz, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01693029 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01693029?

The interventions under investigation include: HX575 epoetin alfa (DRUG), US-licensed epoetin alfa (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01693029?

This trial is sponsored by Sandoz, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial