Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Anemia and Chronic Kidney Disease (CKD), sponsored by Sandoz.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
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 |
What the finished NCT01693029 record still lists
NCT01693029 is an interventional study that assigns participants to a tested intervention. The registered 435 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 422-participant average among 72 other Anemia trials with a reported enrollment target.
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 names 20 study sites across 2 states, led by 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.
Learn More About Clinical Trials
Similar trials for Anemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01693029's enrollment target sits among peer trials
435 18th of 72 higher than 55 of 72 other Anemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
RECRUITING · Phase 3
-
An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions
ACTIVE NOT RECRUITING · Phase 3
-
Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
ACTIVE NOT RECRUITING · Phase 3
-
INTERCEPT Blood System for RBCs Study in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections
ACTIVE NOT RECRUITING · Phase 3
-
Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia
ACTIVE NOT RECRUITING · Phase 3
-
Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05563220 · 435 participants · Phase 1
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
- NCT07088926 · 435 participants · Phase 2
A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
- NCT02622542 · 436 participants · NA
ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy
- NCT05918211 · 436 participants · Phase 3
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia