A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia

Phase 4

Completed

• Conditions: Anemia
• Interventions: Drug: Epoetin Beta

• Registration Number: NCT02569515
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Adult patients 18-65 years of age
• Chronic renal failure (Stages I-III)
• No previous epoetin therapy

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Exclusion Criteria

• Poorly controlled hypertension
• History or evidence of malignancy
• Relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug
• Women who are pregnant or breastfeeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epoetin Beta	Epoetin Beta	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.

Primary Outcome Measures

Name	Time	Method
Percentage of participants who withdrew due to inability to use RecoPen	10 months
Percentage of participantss who change to once weekly NeoRocormon	10 months
Percentage of participants who changed dose during treatmnent	10 months
Percentage of participants with local intolerabilities (pain/allergic reactions)	10 months

Secondary Outcome Measures

Name	Time	Method
Quality of life evaluated by the Short Form 36	10 months