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

This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. Patients with chronic kidney disease will receive NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters, either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 inidividuals

Official Title

A Randomized Study to Compare the Safety and Effectiveness of Two Monitoring Schedules to Maintain Hemoglobin Levels and Iron Parameters in Patients With Renal Anemia Receiving NeoRecormon

Conditions

Anemia

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Percentage of patients achieving target Hb within 20 weeks.

Secondary Outcome Measures:

• Efficacy: % of patients exceeding upper Hb target; % who fail to reach target Hb; median time to achieve Hb target; dose of NeoRecormon required to meet target Hb concentration; % who maintain target iron parameters. Safety: AEs, SAEs

Study Start

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 80 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• adult patients, 18-80 years of age
• stage 3-4 chronic kidney disease (eGFR 15-60mL/min)
• Hb <100g/L, TSAT>=20%, and ferritin >=100 mcg/L at screening.

Exclusion Criteria:

• anticipating to go on renal replacement therapy
• anticipating a living related-donor kidney transplant, or a prior recipient of a kidney transplant
• uncontrolled hypertension
• congestive heart failure
• active bleeding or red blood cell transfusions in 8 weeks prior to screening; systematic hematological disease

Total Enrolment

Contact Details

• GOSFORD, 2250, Australia; Not yet recruiting
• LIVERPOOL, 2170, Australia; Not yet recruiting
• WOOLLOONGABBA, 4102, Australia; Recruiting
• ADELAIDE, 5011, Australia; Not yet recruiting
• PARKVILLE, 3052, Australia; Recruiting
• SYDNEY, 2050, Australia; Not yet recruiting
• PERTH, 6847, Australia; Recruiting
• TASMANIA, 7250, Australia; Recruiting
• HERSTON, 4029, Australia; Not yet recruiting

To find out more, visit Hoffmann La-Roche Clinical Trials