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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00440063




Registration number
NCT00440063
Ethics application status
Date submitted
23/02/2007
Date registered
26/02/2007
Date last updated
20/12/2007

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
ML20828
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
Anaemia

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT00440063
Trial related presentations / publications
Public notes

Contacts
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 https://clinicaltrials.gov/ct2/show/NCT00440063