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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00394953




Registration number
NCT00394953
Ethics application status
Date submitted
1/11/2006
Date registered
2/11/2006
Date last updated
20/01/2017

Titles & IDs
Public title
A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients
Scientific title
A Randomized, Controlled, Open Label, Multicenter, Parallel-group Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis
Secondary ID [1] 0 0
BH17847
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 - Darbepoetin alfa
Treatment: Drugs - methoxy polyethylene glycol-epoetin beta [Mircera]

Experimental: MIRCERA - Eligible participants with anemia in CKD who were on hemodialysis will receive methoxy polyethylene glycol-epoetin beta (MIRCERA [RO0503821]) IV once every month up to 52 weeks. The starting dose of MIRCERA which will be administered during the treatment period will depend on the dose of darbepoetin alfa administered during screening period i.e., 120, 200 and 360 mcg for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.

Active Comparator: Darbepoetin Alfa - Eligible participants with anemia in CKD who were on hemodialysis will receive darbepoetin alfa (Aranesp) IV once every two weeks up to 26 weeks and darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.


Treatment: Drugs: Darbepoetin alfa
As prescribed, iv.

Treatment: Drugs: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms iv / month, starting dose

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period - Randomized participants with an average hemoglobin (Hb) decrease from Baseline (Week -4 to Week -1) not exceeding 1.0 gram per deciliter (g/dL) and an absolute average Hb >= 10.5 g/dL during the evaluation period (Weeks 50-53) were defined as responders. Non-responders included participants without any Hb data during the second treatment period and those who did not meet the response criteria and thus were not included in the analysis.
Timepoint [1] 0 0
Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)
Secondary outcome [1] 0 0
Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time - All participants received once monthly treatment schedule of both MIRCERA and darbepoetin alpha for the respective treatment arms after Week 27 and these analyses are based on the absolute doses. The average dose in Months 11 and 12 was defined as the mean of all administered doses between study Days 302 and 363. The change in dose was calculated as the percentage change between the respective dose at Week 27 and the average corresponding dose during Months 11 and 12 in each treatment group.
Timepoint [1] 0 0
Week 27 to Month 12
Secondary outcome [2] 0 0
Number of Participants With Marked Laboratory Abnormality Over Time - Values of laboratory parameters higher (H) or lower (L) than the Roche defined reference range were considered as abnormality. The laboratory parameters with abnormality were platelets, white blood cells (WBC), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and potassium. Blood samples were drawn before drug administration and before the dialysis session.
Timepoint [2] 0 0
Up to Week 53
Secondary outcome [3] 0 0
Median Blood Pressure Over Time - Systolic and diastolic blood pressures (BP) were measured before and after the dialysis session at every week from Baseline (Week -4 to Week -1) to Week 53. Median pre-dialysis diastolic blood pressure (PrD DBP) , median post-dialysis diastolic blood pressure (PoD DBP), median pre-dialysis systolic blood pressure (PrD SBP), and post-dialysis systolic blood pressure (PoD SBP) were reported at Baseline (Week -4 to Week -1) , Week 28 and Week 52.
Timepoint [3] 0 0
Baseline (Week -4 to Week -1), Week 28, and Week 52
Secondary outcome [4] 0 0
Mean Pulse Rate Over Time - Pulse rate is defined as the number of heartbeats in a minute and was assessed in sitting position of the participants at every week from Baseline (Week -4 to Week -1) to Week 53. Summary data of mean values of pulse rate are presented at Baseline (Week -4 to Week -1), Week 28 and Week 52.
Timepoint [4] 0 0
Baseline (Week -4 to Week -1), Week 28, and Week 52
Secondary outcome [5] 0 0
Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths - An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any adverse event that can result in death or is life-threatening or required in participants hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above. SAEs were reported up to Week 56, while nonserious AEs up to Week 52.
Timepoint [5] 0 0
From screening to Week 56

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

- chronic renal anemia;

- hemodialysis 3 times weekly for >=12 weeks before screening, and during
screening/baseline period;

- receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and
during screening/baseline period.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- overt gastrointestinal bleeding within 8 weeks before screening or during
screening/baseline period;

- transfusion of red blood cells within 8 weeks before screening or during
screening/baseline period;

- active malignancy;

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 hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Gosford
Recruitment hospital [4] 0 0
- Parkville
Recruitment hospital [5] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3186 - Clayton
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Austria
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Linz
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Austria
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Wien
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Belgium
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Aalst
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Bruxelles
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Roeselare
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Ontario
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Aalborg
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Hillerød
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Roskilde
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Tampere
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Turku
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Auch
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Bordeaux
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Boulogne
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Cergy Pontoise
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Chamalieres
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Dijon
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Herouville Saint Clair
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La Tronche
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Lyon
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Nimes
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Paris
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Reims
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Rennes
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Saint Herblain
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Saint Ouen
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St Brieuc
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Germany
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Bad Hersfeld
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Bonn
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München
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Germany
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Villingen-schwenningen
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Bologna
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Italy
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Como
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Italy
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Genova
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Italy
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Lecco
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Italy
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Modena
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Italy
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Pavia
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Italy
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Prato
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Venezia
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Dordrecht
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Portugal
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Leiria
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Alicante
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Badalona
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Barcelona
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Bilbao
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Córdoba
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Switzerland
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Aarau
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Lausanne
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United Kingdom
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Belfast
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Canterbury
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Manchester
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United Kingdom
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Truro

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

Ethics approval
Ethics application status

Summary
Brief summary
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa,
administered at extended dosing intervals, in the maintenance treatment of anemia in patients
with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving
once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to
receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360
micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study)
or intravenous darbepoetin alfa every 2 weeks before switching to once monthly
administration. The anticipated time on study treatment is 3-12 months, and the target sample
size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/show/NCT00394953
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
Other publications