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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00077623




Registration number
NCT00077623
Ethics application status
Date submitted
10/02/2004
Date registered
12/02/2004
Date last updated
26/04/2016

Titles & IDs
Public title
A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.
Scientific title
A Randomized, Controlled, Open-Label, Multi- Center, Parallel-Group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Subcutaneously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis
Secondary ID [1] 0 0
BA16740
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 alfa or beta
Treatment: Drugs - methoxy polyethylene glycol-epoetin beta (Mircera)
Treatment: Drugs - methoxy polyethylene glycol-epoetin beta (Mircera)

Experimental: RO0503821 (1x/2 Weeks) - Eligible participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the week preceding the switch to the study drug.

Experimental: RO0503821 (1x/4 Weeks) - Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.

Active Comparator: Epoetin Reference - Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks .


Treatment: Drugs: epoetin alfa or beta
iv 3 times weekly, as prescribed

Treatment: Drugs: methoxy polyethylene glycol-epoetin beta (Mircera)
60, 100 or 180 micrograms sc (starting dose) every 2 weeks

Treatment: Drugs: methoxy polyethylene glycol-epoetin beta (Mircera)
60, 100 or 180 micrograms sc (starting dose) every 4 weeks

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

Outcomes
Primary outcome [1] 0 0
Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods - A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.
Timepoint [1] 0 0
Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)
Secondary outcome [1] 0 0
Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration - All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36.
Timepoint [1] 0 0
Evaluation period (Week 29 to Week 36)
Secondary outcome [2] 0 0
Number of Participants With Red Blood Cell Transfusions - The number of participants who received RBC transfusions were reported.
Timepoint [2] 0 0
Up to Week 36
Secondary outcome [3] 0 0
Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths - An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Timepoint [3] 0 0
Up to week 52
Secondary outcome [4] 0 0
Number of Participants With Marked Laboratory Abnormalities - A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10^9/L), platelets (100 - 550 10^9/L), alanine aminotransferase (ALAT) (0 - 110 units per liter [U/L]), alkaline phosphatase (ALP [0 - 220 U/L]), aspartate aminotransferase (ASAT) (0 - 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimoles per liter [mmol/L]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L).
Timepoint [4] 0 0
Up to week 52
Secondary outcome [5] 0 0
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants - Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants.
Timepoint [5] 0 0
From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Secondary outcome [6] 0 0
Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants - Pulse rate in beats per minute (BpM) was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in haemodialysis participants.
Timepoint [6] 0 0
From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Secondary outcome [7] 0 0
Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants - Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants.
Timepoint [7] 0 0
From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Secondary outcome [8] 0 0
Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants - Pulse rate in BpM was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in peritoneal dialysis participants.
Timepoint [8] 0 0
From Baseline (Week -4 to Week -1) to Week 36 and Week 52

Eligibility
Key inclusion criteria
- adult patients >=18 years of age;

- chronic renal anemia;

- on dialysis therapy for at least 12 weeks before screening;

- receiving sc epoetin for at least 8 weeks before screening.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- women who are pregnant, breastfeeding or using unreliable birth control methods;

- administration of another investigational drug within 4 weeks before screening, or
during the study period.

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 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 outside Australia
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Arkansas
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Oregon
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West Virginia
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Belgium
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Bruxelles
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Belgium
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Edegem
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Gent
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Hasselt
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HUS
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Tampere
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Pantin
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Germany
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Cremona
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Lecco
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Wellington
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Ponce
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South Africa
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Durban
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Alcorcon
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Barcelona
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Madrid
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Palma de Mallorca
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Pamplona
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Santiago de Compostela
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Sweden
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Huddinge
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Karlstad
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Taichung
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Taipei
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Thailand
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Bangkok
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Belfast
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Cambridge
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Dundee
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Exeter
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Leicester
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United Kingdom
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London

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 assess the efficacy and safety of subcutaneous (sc) Mircera given as
maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who
were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years
and the target sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/show/NCT00077623
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

No data has been provided for results reporting
Summary results
Other publications