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

An Open-Label Study of the Tolerability and Flexibility of Multi-Dose NeoRecormon Administered by Reco-Pen in Pre-Dialysis Patients With Chronic Renal Anemia.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02569515

Enrollment

Registered

2015-10-06

Start date

2004-10-31

Completion date

2006-07-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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.

Interventions

DRUGEpoetin 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Quality of life evaluated by the Short Form 36	10 months

Countries

Bulgaria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026