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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00077766
Registration number
NCT00077766
Ethics application status
Date submitted
12/02/2004
Date registered
16/02/2004
Date last updated
26/10/2016
Titles & IDs
Public title
A Study of Intravenous 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 Intravenously 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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BA17283
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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 - Darbepoetin alfa
Treatment: Drugs - methoxy polyethylene glycol-epoetin beta [Mircera]
Experimental: RO0503821 (1x/2 Weeks) - Eligible participants will be administered with RO0503821 (\[methoxy polyethylene glycol-epoetin beta\] {Mircera}) intravenously (IV), every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively).
Active comparator: Darbepoetin (1x/1-2 Weeks) - Eligible participants will be administered with darbepoetin alfa IV, every week or every 2 weeks during Weeks 1 through 52.
Treatment: Drugs: Darbepoetin alfa
Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52.
Treatment: Drugs: methoxy polyethylene glycol-epoetin beta [Mircera]
RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively).
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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 (g/dL) From Baseline to Evaluation Period
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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 approach, for both periods separately. Change in Hb concentration between the baseline (Week -4 to Week -1) 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. The analysis used the last observation carried forward (LOCF) for missing Hb values for correction of the impact of early drop outs. The baseline period was defined as Week -4 to Week -1. The evaluation period was 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 Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration
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Assessment method [1]
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The average Hb of all values recorded during the evaluation period was calculated, and this average was subtracted from the average baseline Hb values for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline Hb concentration is displayed. The evaluation period was 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 [2]
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Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods
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Assessment method [2]
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A combined data of the number of participants who received Red Blood Cell (RBC) transfusions during the titration and evaluation periods is reported. A period of 28 weeks after the first dose of the study drug was used for dose titration and stabilization of Hb concentration. The dose titration period was followed by an 8-week evaluation period (weeks 29 to 36).
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Timepoint [2]
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Week 1 to Week 36
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Secondary outcome [3]
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Number of Participants With Marked Laboratory Abnormalities
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Assessment method [3]
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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/liter \[L\]), 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 millimole per liter \[mmol/L\]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L).
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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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Mean Change in Blood Pressure From Baseline at Week 36 and Week 52
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Assessment method [4]
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Blood pressure Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) was measured by manual assessment or automated reading throughout the study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic and diastolic blood pressures were recorded before dialysis (BD) and after dialysis (AD).
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Timepoint [4]
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Baseline, Week 36, and Week 52
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Secondary outcome [5]
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Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52
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Assessment method [5]
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Change in pulse rate (beats per minute \[bpm\]) from baseline values includes only those participants with both a baseline (BL) value and a value for specified time period.
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Timepoint [5]
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Baseline, Week 36, and Week 52
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Secondary outcome [6]
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Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths
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Assessment method [6]
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An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.
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Timepoint [6]
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Up to 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 darbepoetin alfa iv 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
1/08/2005
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Sample size
Target
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Accrual to date
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Final
313
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Blacktown
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Recruitment hospital [2]
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- Brisbane
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Recruitment hospital [3]
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- Clayton
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Recruitment hospital [4]
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- Gosford
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Recruitment hospital [5]
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- Parkville
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Recruitment hospital [6]
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- Sydney
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Recruitment postcode(s) [1]
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NSW 2148 - Blacktown
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Recruitment postcode(s) [2]
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4102 - Brisbane
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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2250 - Gosford
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Recruitment postcode(s) [5]
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3050 - Parkville
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Recruitment postcode(s) [6]
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1871 - Sydney
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Recruitment outside Australia
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Austria
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Graz
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Belgium
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Aalst
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Belgium
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Bruxelles
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Belgium
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Liege
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Alberta
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British Columbia
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Aalborg
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Odense
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Montpellier
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France
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Nice
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France
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France
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Tarbes
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France
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Germany
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Nürnberg
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Lecco
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Italy
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Livorno
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Italy
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Messina
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Italy
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Pavia
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Badalona
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Córdoba
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Madrid
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Oviedo
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Salamanca
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Karlstad
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Stockholm
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Aarau
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Switzerland
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Lausanne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. 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/NCT00077766
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Trial related presentations / publications
Canaud B, Mingardi G, Braun J, Aljama P, Kerr PG, Locatelli F, Villa G, Van Vlem B, McMahon AW, Kerloeguen C, Beyer U; STRIATA Study Investigators. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Nephrol Dial Transplant. 2008 Nov;23(11):3654-61. doi: 10.1093/ndt/gfn320. Epub 2008 Jun 27.
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Public notes
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Contacts
Principal investigator
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Address
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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/NCT00077766
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