HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD) (SENSE)
This study is currently recruiting participants.
Verified March 2013 by Sandoz
Information provided by (Responsible Party):
First received: April 5, 2012
Last updated: March 6, 2013
Last verified: March 2013
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of HX575 Epoetin Alfa in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Patients|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sandoz:
Primary Outcome Measures:
- Incidence of antibody formation against epoetin [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]The incidence of antibody formation against epoetin will be tabulated with absolute and relative frequencies.
Secondary Outcome Measures:
- Hemoglobin levels over time and change from baseline [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]Mean Hb levels as well as mean changes in Hb levels will be presented by visit.
- Weekly epoetin dosage (IU and IU/kg) over time and change from baseline [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]The weekly epoetin dose (in total IU epoetin and in IU/kg BW) will be presented as mean time courses as well as absolute changes compared to study week 1.
- Incidence and severity of AEs, and of drug related AEs [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]Incidences of treatment-emergent AEs and related AEs, treatment-emergent SAEs, and related SAEs will be summarized by MedDRA primary system organ class (SOC) and preferred term overall.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: HX575 epoetin alfa (Sandoz)
Drug: HX575 epoetin alfa (Sandoz)
Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.
Other Name: Binocrit®, Epoetin alfa HEXAL®, Novicrit®, Abseamed®
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576341
|Contact: Sandoz Biopharmaceuticals||0049 8024 476 0|
|Homberg, Hessen, Germany|
|Contact: Thilo Menzer, Dr. med.|
|Centre for Diabetology and Nephrology||Recruiting|
|Duesseldorf, North Rhine-Westphalia, Germany|
|Contact: Frank Dellanna, Prof.|
|Dialysis Centre Nettetal||Recruiting|
|Nettetal, North Rhine-Westphalia, Germany|
|Contact: Stefan Degenhardt, Dr. med.|
Sponsors and Collaborators
|Study Chair:||Sandoz Biopharmaceuticals||Sandoz|