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Clinical Trial Details

Trial ID: L0238
Source ID: NCT01576341
Associated Drug: Hx575 Epoetin Alfa (Sandoz)
Title: HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
Acronym: SENSE
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01576341/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: HX575 epoetin alfa (Sandoz)
Outcome Measures: Primary: Anti-Erythropoietin (EPO) Antibodies, The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay, 52 weeks | Secondary: Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study), Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1), 52 weeks
Sponsor/Collaborators: Sponsor: Sandoz
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 417
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-04
Completion Date: 2015-06
Results First Posted: 2017-06-19
Last Update Posted: 2017-06-19
Locations: Sandoz Investigative Site, Duesseldorf, Germany|Sandoz Investigative Site, Homberg, Germany|Sandoz Investigative Site, Nettetal, Germany|Sandoz Investigative Site, Bari, Italy|Sandoz Investigative Site, Czestochowa, Poland|Sandoz Investigative Site, Gdansk, Poland|Sandoz Investigative Site, Gdynia, Poland|Sandoz Investigative Site, Olkusz, Poland|Sandoz Investigative Site, Plock, Poland|Sandoz Investigative Site, Poznan, Poland|Sandoz Investigative Site, Wadowice, Poland|Sandoz Investigative Site, Warzawa, Poland|Sandoz Investigative Site, Bucuresti, Romania|Sandoz Investigative Site, Constanta, Romania|Sandoz Investigative Site, Lasi, Romania|Sandoz Investigative Site, Oradea, Romania|Sandoz Investigative Site, Timisoara, Romania|Sandoz Investigative Site, Chelyabinsk, Russian Federation|Sandoz Investigative Site, Kemerovo, Russian Federation|Sandoz Investigative Site, Kolomna, Russian Federation|Sandoz Investigative Site, Moscow, Russian Federation|Sandoz Investigative Site, Mytischi, Russian Federation|Sandoz Investigative Site, Nizhny Novgorod, Russian Federation|Sandoz Investigative Site, Novosibirsk, Russian Federation|Sandoz Investigative Site, Orenburg, Russian Federation|Sandoz Investigative Site, Petrozavodsk, Russian Federation|Sandoz Investigative Site, Podolsk, Russian Federation|Sandoz Investigative Site, Pyatigorsk, Russian Federation|Sandoz Investigative Site, Ryazan, Russian Federation|Sandoz Investigative Site, Saratov, Russian Federation|Sandoz Investigative Site, Smolensk, Russian Federation|Sandoz Investigative Site, St. Petersburg, Russian Federation|Sandoz Investigative Site, Yaroslavl, Russian Federation|Sandoz Investigative Site, Yekaterinburg, Russian Federation|Sandoz Investigative Site, Adana, Turkey|Sandoz Investigative Site, Ankara, Turkey|Sandoz Investigative Site, Istanbul, Turkey|Sandoz Investigative Site, Chernovtsy, Ukraine|Sandoz Investigative Site, Dnipropetrovsk, Ukraine|Sandoz Investigative Site, Donetsk, Ukraine|Sandoz Investigative Site, Ivano-Frankivsk, Ukraine|Sandoz Investigative Site, Kharkiv, Ukraine|Sandoz Investigative Site, Kyiv, Ukraine|Sandoz Investigative Site, Lugansk, Ukraine|Sandoz Investigative Site, Nikolaev, Ukraine|Sandoz Investigative Site, Poltava, Ukraine|Sandoz Investigative Site, Ternopil, Ukraine|Sandoz Investigative Site, Uzhgorod, Ukraine|Sandoz Investigative Site, Zaporizhya, Ukraine|Sandoz Investigative Site, Zhitomyr, Ukraine
URL: https://clinicaltrials.gov/show/NCT01576341

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress