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OpenTrials
Completed

NCT Number: NCT00413101

A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.

This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart function and quality of life will be measured before and after anemia correction. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novi Sad, 21000, Serbia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients, 18-75 years of age;
  • end-stage renal disease;
  • on renal dialysis >= 3 months;
  • receiving NeoRecormon treatment >= 3 months;
  • Hb stable and <105g/L, and LVMI >160g/m2.

Exclusion criteria

  • unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;
  • use of any ESA other than NeoRecormon;
  • acute infection;
  • use of iv NeoRecormon.

Treatment and study plan

epoetin beta [NeoRecormon]

Drug

At a dose to achieve and maintain an Hb level of 120-135g/L

Primary outcomes

  1. Hb level, BP.

    Time frame: Throughout study

  2. LVMI ejection fraction, ejection fraction.

    Time frame: 12 months

Secondary outcomes

  1. SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-Label Study to Investigate Improvement in Heart Function After Complete Anemia Correction With NeoRecormon in Patients With End-Stage Renal Disease Already Receiving Sub-Optimal Doses of NeoRecormon

Important dates

Study completion
2008
First posted
Dec 19, 2006
Registry last updated
May 14, 2009

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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