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

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: Epoetin Beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT02569515

ML18101

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Epoetin Beta

Experimental group

Description:

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.

Treatment:

Drug: Epoetin Beta