Anemia
Conditions
Brief summary
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.
Interventions
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving target Hb within 20 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Australia
Outcome results
None listed