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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00077623
Registration number
NCT00077623
Ethics application status
Date submitted
10/02/2004
Date registered
13/02/2004
Date last updated
25/05/2016
Titles & IDs
Public title
A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.
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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
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Secondary ID [1]
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BA16740
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anemia
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Condition category
Condition code
Blood
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Anaemia
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)
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Secondary outcome [1]
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Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration
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Assessment method [1]
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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.
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Timepoint [1]
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Evaluation period (Week 29 to Week 36)
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Secondary outcome [2]
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Number of Participants With Red Blood Cell Transfusions
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Assessment method [2]
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The number of participants who received RBC transfusions were reported.
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Timepoint [2]
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Up to Week 36
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Secondary outcome [3]
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Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths
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Assessment method [3]
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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.
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Timepoint [3]
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Up to week 52
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Secondary outcome [4]
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Number of Participants With Marked Laboratory Abnormalities
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Assessment method [4]
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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).
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Timepoint [4]
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Up to week 52
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Secondary outcome [5]
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Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants
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Assessment method [5]
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Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants.
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Timepoint [5]
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From Baseline (Week -4 to Week -1) to Week 36 and Week 52
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Secondary outcome [6]
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Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants
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Assessment method [6]
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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.
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Timepoint [6]
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From Baseline (Week -4 to Week -1) to Week 36 and Week 52
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Secondary outcome [7]
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Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants
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Assessment method [7]
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Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants.
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Timepoint [7]
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From Baseline (Week -4 to Week -1) to Week 36 and Week 52
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Secondary outcome [8]
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Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants
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Assessment method [8]
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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.
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Timepoint [8]
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From Baseline (Week -4 to Week -1) to Week 36 and Week 52
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2005
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Sample size
Target
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Accrual to date
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Final
572
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Recruitment in Australia
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Name
Hoffmann-La Roche
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00077623
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Hoffmann-La Roche
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00077623
Download to PDF