- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00717366
Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis
August 8, 2017 updated by: Hoffmann-La Roche
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Children'S Hospital; Department of Nephrology
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Bruxelles, Belgium, 1020
- Hôpital Enfants Reine Fabiola
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Leuven, Belgium, 3000
- UZ Leuven Gasthuisberg
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Bron, France, 69677
- Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie
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Lille, France, 59037
- Hopital Jeanne De Flandre; Cons Pediatrie
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Marseille, France, 13385
- Hopital Timone Enfants; Nephrologie Hemodialyse
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Montpellier, France, 34295
- Hopital Arnaud De Villeneuve; Pediatrie I
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Paris, France, 75019
- Hôpital Robert Debré; Nephrologie pediatrique
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Paris, France, 75571
- Hopital Armand Trousseau; Pediatrie Nephrologie
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Strasbourg, France, 67098
- Höpital Hautepierre; Pediatrie 1
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Hamburg, Germany, 20246
- KfH Nierenzentrum für Kinder und Jugendliche
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Heidelberg, Germany, 69120
- KfH-Nierenzentrum für Kinder und Jugendliche
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Köln, Germany, 50937
- Klinik der Uni zu Köln; Kinderklinik
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Memmingen, Germany, 87700
- Kinderklinik Memmingen; Kinderdialysezentrum
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Münster, Germany, 48149
- KfH-Nierenzentrum für Kinder und Jugendliche
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Budapest, Hungary, 1083
- Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center
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Lazio
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Roma, Lazio, Italy, 00165
- Ospedale Pediatrico Bambino Gesu; U.O. Di Nefrologia E Dialisi
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Liguria
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Genova, Liguria, Italy, 16148
- IRCCS G. Gaslini; U.O. Nefrologia, Dialisi e Trapianto
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Piemonte
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Torino, Piemonte, Italy, 10126
- Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto
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Veneto
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Padova, Veneto, Italy, 35128
- A.O. Di Padova; Dipartimento Di Pediatria U.O. Di Nefrologia Pediatrica, Dialisi e Trapianto
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Gdansk, Poland, 80-294
- Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy
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Lodz, Poland, 93-338
- Instytut "Centrum Zdrowia Matki Polki; Klinika Nefrologii i Dializoterapii
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Lublin, Poland, 20-093
- Dzieciecy Szpital Kliniczny; Klinika Nefrologii Dzieciecej
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Szczecin, Poland, 70-410
- SPSZOZ Zdroje Oddzial Pediatrii; Nefrologii i Toksykologii ze Stacja Dializ
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Torun, Poland, 87-100
- Wojewodzki Szpital Dzieciecy; Osrodek Chorob Nerek i Dializoterapii
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Warszawa, Poland, 04-730
- Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego
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Wroclaw, Poland, 50-369
- Akademia Medyczna im. Piastow Slaskich; Katedra i Klinika Nefrologii Pediatrycznej
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Bucharest, Romania, 022328
- Fundeni Clinical Institute
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Iasi, Romania, 700309
- St. Maria Emergency Clinical Hospital for Children
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Moscow, Russian Federation, 107014
- DGCB St. Vladimir; Pediatric nephrologist
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Saint-Petersburg, Russian Federation, 198205
- SBIH Children City Hospital #1; Dialysis department
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Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
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Madrid, Spain, 28046
- Hospital Universitario La Paz: Nefrologia Pediatrica
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica
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Valencia, Spain, 46009
- Hospital Universitario la Fe; Servicio de Nefrologia Pediatrica
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Bangkok, Thailand, 10310
- Chulalongkorn university Faculty of Medicine;Department of Pediatrics
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Bangkok, Thailand, 10700
- Siriraj Hospital, Faculty of Medicine; Department of Pediatrics
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Kiev, Ukraine, 04209
- Kiev city childrens nephrological center of hospital #1; Nephrology and RRT
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Zaporizhzhia, Ukraine, 69076
- Public Institution Zaporizhzhia City Multispecialty Children's Hospital #5; Allergologic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Will be administered IV, every 4 weeks.
Other Names:
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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.
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Will be administered IV, every 4 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Average Hb Concentration Between Baseline and Evaluation Period
Time Frame: Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
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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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Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb
Time Frame: Evaluation Period (Week 17 to Week 21)
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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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Evaluation Period (Week 17 to Week 21)
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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
Time Frame: Evaluation Period (Week 17 to Week 21)
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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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Evaluation Period (Week 17 to Week 21)
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Number of Participants With Blood Transfusions
Time Frame: Baseline to Week 20
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Baseline to Week 20
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Change in Average Reticulocyte Count Between the Baseline and Evaluation Period
Time Frame: Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
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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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Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
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Maximum Observed Serum Concentration (Cmax) of MIRCERA
Time Frame: 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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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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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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Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA
Time Frame: 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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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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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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Time to Reach Cmax (Tmax) of MIRCERA
Time Frame: 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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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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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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Apparent Terminal Phase Half-Life (t1/2) of MIRCERA
Time Frame: 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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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 λz; where λz = terminal elimination rate constant.
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (ACTUAL)
March 1, 2016
Study Completion (ACTUAL)
March 1, 2016
Study Registration Dates
First Submitted
July 16, 2008
First Submitted That Met QC Criteria
July 16, 2008
First Posted (ESTIMATE)
July 17, 2008
Study Record Updates
Last Update Posted (ACTUAL)
September 8, 2017
Last Update Submitted That Met QC Criteria
August 8, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NH19707
- 2007-007758-70 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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