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OpenTrials
Completed

NCT Number: NCT02569515

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epoetin beta

Drug

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.

Other names: NeoRecormon

Primary outcomes

  1. Percentage of participantss who change to once weekly NeoRocormon

    Time frame: 10 months

  2. Percentage of participants with local intolerabilities (pain/allergic reactions)

    Time frame: 10 months

  3. Percentage of participants who withdrew due to inability to use RecoPen

    Time frame: 10 months

  4. Percentage of participants who changed dose during treatmnent

    Time frame: 10 months

Secondary outcomes

  1. Quality of life evaluated by the Short Form 36

    Time frame: 10 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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.

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Oct 6, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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