A Phase 4 interventional study of Epoetin Beta in Anemia, sponsored by Hoffmann-La Roche. Completed at 4 sites in Bulgaria. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic renal anemia. The anticipated time on study treatment is 10 months, and the target sample size is 60 individuals.
1,768 studies on the registry are indexed under Anemia; 244 are open to participants now.
This study's enrollment of 58 is below the median of 96 across 1,318 interventional studies indexed under Anemia.
Browse Anemia studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.
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Exclusion Criteria:
Patients will be administered 3 times (X) 30 International unis per kilogram(IU/Kg body weight per week of eopetin beta subcurtaneously using the device RecoPen. The dosage could be increased every 4 weeks by 3 X20 IU/Kg.
Drug: Epoetin Beta
Initial dose: 3X30 IU/Kg body weight administered subcutaneously using RecoPen. Dosage could be increased by 3X20 IU/Kg every 4 weeks up to a maximum of 720 IU/Kg per week.
Also known as: NeoRecormon
Percentage of participantss who change to once weekly NeoRocormon
Time frame: 10 months
Percentage of participants with local intolerabilities (pain/allergic reactions)
Time frame: 10 months
Percentage of participants who withdrew due to inability to use RecoPen
Time frame: 10 months
Percentage of participants who changed dose during treatmnent
Time frame: 10 months
Quality of life evaluated by the Short Form 36
Time frame: 10 months
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Epoetin beta