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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.
Scientific 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
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia 0 0
Condition category
Condition code
Blood 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Drugs - epoetin beta [NeoRecormon]

Treatment: Drugs: epoetin beta [NeoRecormon]

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Percentage of patients achieving target Hb within 20 weeks.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Key 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.
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key 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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Gosford
Recruitment hospital [3] 0 0
- Herston
Recruitment hospital [4] 0 0
- Liverpool
Recruitment hospital [5] 0 0
- Parkville
Recruitment hospital [6] 0 0
- Perth
Recruitment hospital [7] 0 0
- Sydney
Recruitment hospital [8] 0 0
- Tasmania
Recruitment hospital [9] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Gosford
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Liverpool
Recruitment postcode(s) [5] 0 0
- Parkville
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment postcode(s) [7] 0 0
- Sydney
Recruitment postcode(s) [8] 0 0
- Tasmania
Recruitment postcode(s) [9] 0 0
- Woolloongabba

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Hoffmann-La Roche

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see