A Study of NeoRecormon in Patients With Chronic Kidney Disease.

This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of 120-135 g/L), or to a control group not receiving NeoRecormon. 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

Belgrade, 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, not on dialysis;
Hb <110g/L.

Exclusion criteria

unstable hypertension;
acute infections;
use of i.v. NeoRecormon, or use of any other ESA beside NeoRecormon;
myocardial infarction, unstable angina or venous thrombosis within 6 months before start of treatment.

Treatment and study plan

epoetin beta [NeoRecormon]

Drug

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

Primary outcomes

Hb level, decline in renal function, 24h proteinuria, creatinine clearance.

Time frame: Throughout study

Secondary outcomes

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 the Effect of NeoRecormon on Hemoglobin Level and Renal Function in Patients With Chronic Kidney Disease, Stage 2-4

Important dates

Study completion: 2008
First posted: Feb 21, 2007
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.

Published trials that share one or more normalized conditions with this study.

Completed