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

Hoffmann-La Roche58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

Epoetin BetaDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Sofia, Bulgaria

Unnamed facility

Sofia, Bulgaria

Unnamed facility

Sofia, Bulgaria

Unnamed facility

Varna, Bulgaria

Outcomes

Primary Outcomes

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

Secondary Outcomes

Quality of life evaluated by the Short Form 36

Time frame: 10 months

Data from ClinicalTrials.gov

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