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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/NCT00717366
Registration number
NCT00717366
Ethics application status
Date submitted
16/07/2008
Date registered
17/07/2008
Date last updated
8/09/2017
Titles & IDs
Public title
Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis
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Scientific title
An Open-Label Multi-center, Multiple Dose Study to Determine the Optimum Starting Dose of Intravenous MIRCERA for Maintenance Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease on Hemodialysis
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Secondary ID [1]
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2007-007758-70
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Secondary ID [2]
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NH19707
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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:
Renal Anemia
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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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 - Methoxy Polyethylene Glycol-Epoetin Beta
Experimental: MIRCERA Group 1: Intermediate-Conversion-Factor Group - Participants will receive methoxy polyethylene glycol-epoetin beta (MIRCERA) IV injection at a starting dose based on an intermediate conversion factor from their previous Erythropoiesis-stimulating Agent (ESA) dose (4 * previous weekly epoetin dose [international units {IU}]/250 or 4 * previous weekly darbepoetin alfa dose [micrograms {mcg}]/1.1) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with hemoglobin (Hb) level within ± 1 grams per deciliter (g/dL) of their baseline Hb level and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks.
Experimental: MIRCERA Group 2: High-Conversion-Factor Group - Participants will receive MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with Hb within ± 1 g/dL of their baseline Hb and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks.
Treatment: Drugs: Methoxy Polyethylene Glycol-Epoetin Beta
Will be administered IV, 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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Change in Average Hb Concentration Between Baseline and Evaluation Period
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Assessment method [1]
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A time adjusted average baseline Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration.
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Timepoint [1]
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Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
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Secondary outcome [1]
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Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb
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Assessment method [1]
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Baseline Hb value was defined as the average Hb concentration from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).
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Timepoint [1]
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Evaluation Period (Week 17 to Week 21)
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Secondary outcome [2]
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Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL
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Assessment method [2]
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The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).
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Timepoint [2]
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Evaluation Period (Week 17 to Week 21)
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Secondary outcome [3]
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Number of Participants With Blood Transfusions
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Assessment method [3]
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Timepoint [3]
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Baseline to Week 20
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Secondary outcome [4]
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Change in Average Reticulocyte Count Between the Baseline and Evaluation Period
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Assessment method [4]
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A time adjusted average baseline reticulocyte count for each individual was calculated using an AUC approach from all available reticulocyte counts taken during the baseline period (Day -20 to Day 1). The average evaluation period reticulocyte count for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Weeks 17 to 21). The change in reticulocyte count between the baseline and evaluation periods was calculated by subtracting the baseline reticulocyte count from the evaluation period reticulocyte count. Relative reticulocytes were recorded conversion to absolute values was performed.
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Timepoint [4]
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Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
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Secondary outcome [5]
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Maximum Observed Serum Concentration (Cmax) of MIRCERA
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Assessment method [5]
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Cmax was defined as the highest serum concentration observed from all sample collection timepoints (as provided in timeframe) and was averaged out among participants and reported.
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Timepoint [5]
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Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13
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Secondary outcome [6]
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Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA
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Assessment method [6]
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Area under the serum concentration versus time curve over 672 hours. AUC0-672h represents area under the serum concentration versus time curve from time zero to end of dosing interval (AUC0-tau).
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Timepoint [6]
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Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13
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Secondary outcome [7]
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Time to Reach Cmax (Tmax) of MIRCERA
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Assessment method [7]
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Tmax was defined as the time (in hours) to achieve Cmax (Cmax was defined as the highest serum concentration observed over all sample collection timepoints [as provided in timeframe]). The median time, among all participants, was reported.
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Timepoint [7]
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Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13
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Secondary outcome [8]
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Apparent Terminal Phase Half-Life (t1/2) of MIRCERA
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Assessment method [8]
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t1/2 was defined as the time (in hours) measured (from all sample collection timepoints [as provided in timeframe]) for the serum concentration to decrease by one half. The t1/2 was calculated as natural logarithm of 2 divided by ?z; where ?z = terminal elimination rate constant.
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Timepoint [8]
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Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13
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Eligibility
Key inclusion criteria
- Children aged 5-17 years (in Russia only: 12-17 years) with clinically stable chronic
renal anemia
- Hemodialysis for greater than or equal to (>=) 8 weeks
- Intravenous stable maintenance treatment with epoetin alfa, epoetin beta, or
darbepoetin alfa for >= 8 weeks before screening and with no weekly dose change >= 25
percent (%) (increase or decrease) during the 2 weeks of screening
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Minimum age
5
Years
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Maximum age
17
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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
- Overt gastrointestinal bleeding within 8 weeks before screening or during the
screening period
- Red blood cell (RBC) transfusions within 8 weeks before screening or during the
screening period
- Active malignant disease
- Pure red cell aplasia (PRCA) or history of PRCA
- Pregnant or lactating females
- Sexually active participants: not willing to use reliable contraception during
treatment and for 90 days following the end of treatment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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 2
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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
1/07/2008
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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
1/03/2016
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Sample size
Target
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Accrual to date
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Final
64
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Children'S Hospital; Department of Nephrology - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment outside Australia
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Belgium
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State/province [1]
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Bruxelles
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Belgium
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Leuven
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France
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Bron
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France
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Lille
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France
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Marseille
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France
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Montpellier
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France
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Paris
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France
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Strasbourg
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Köln
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Germany
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Memmingen
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Germany
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Münster
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Hungary
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Budapest
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Piemonte
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Italy
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Veneto
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Gdansk
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Lodz
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Lublin
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Szczecin
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Torun
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Warszawa
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Wroclaw
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Romania
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Bucharest
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Romania
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Iasi
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Thailand
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Bangkok
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Ukraine
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Kiev
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Ukraine
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Zaporizhzhia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This sequential study will assess the efficacy and safety of multiple doses of intravenous
(IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum
starting dose for maintenance treatment of anemia in children with chronic kidney disease on
hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin
alfa during the screening period, after which they will receive IV MIRCERA monthly, at a
starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on
the response achieved, another group may be selected to receive a higher or a lower dose.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00717366
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00717366
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