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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-07-17
Enrollment: 64
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Average Hb Concentration Between Baseline and Evaluation Period
timeFrame: Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
Secondary outcomes:
measure: Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb
timeFrame: Evaluation Period (Week 17 to Week 21)
measure: Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL
timeFrame: Evaluation Period (Week 17 to Week 21)
measure: Number of Participants With Blood Transfusions
timeFrame: Baseline to Week 20
measure: Change in Average Reticulocyte Count Between the Baseline and Evaluation Period
timeFrame: Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
measure: Maximum Observed Serum Concentration (Cmax) of MIRCERA
timeFrame: 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
measure: Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA
timeFrame: 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
measure: Time to Reach Cmax (Tmax) of MIRCERA
timeFrame: 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
measure: Apparent Terminal Phase Half-Life (t1/2) of MIRCERA
timeFrame: 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
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Royal Children'S Hospital; Department of Nephrology
state: Victoria
city: Bruxelles
country: Belgium
facility: Hôpital Enfants Reine Fabiola
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Bron
country: France
facility: Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie
city: Lille
country: France
facility: Hopital Jeanne De Flandre; Cons Pediatrie
city: Marseille
country: France
facility: Hopital Timone Enfants; Nephrologie Hemodialyse
city: Montpellier
country: France
facility: Hopital Arnaud De Villeneuve; Pediatrie I
city: Paris
country: France
facility: Hôpital Robert Debré; Nephrologie pediatrique
city: Paris
country: France
facility: Hopital Armand Trousseau; Pediatrie Nephrologie
city: Strasbourg
country: France
facility: Höpital Hautepierre; Pediatrie 1
city: Hamburg
country: Germany
facility: KfH Nierenzentrum für Kinder und Jugendliche
city: Heidelberg
country: Germany
facility: KfH-Nierenzentrum fur Kinder und Jugendliche
city: Köln
country: Germany
facility: Klinik der Uni zu Köln; Kinderklinik
city: Memmingen
country: Germany
facility: Kinderklinik Memmingen; Kinderdialysezentrum
city: Münster
country: Germany
facility: KfH-Nierenzentrum für Kinder und Jugendliche
city: Budapest
country: Hungary
facility: Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesu; U.O. Di Nefrologia E Dialisi
state: Lazio
city: Genova
country: Italy
facility: IRCCS G. Gaslini; U.O. Nefrologia, Dialisi e Trapianto
state: Liguria
city: Torino
country: Italy
facility: Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto
state: Piemonte
city: Padova
country: Italy
facility: A.O. Di Padova; Dipartimento Di Pediatria U.O. Di Nefrologia Pediatrica, Dialisi e Trapianto
state: Veneto
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy
city: Lodz
country: Poland
facility: Instytut "Centrum Zdrowia Matki Polki; Klinika Nefrologii i Dializoterapii
city: Lublin
country: Poland
facility: Dzieciecy Szpital Kliniczny; Klinika Nefrologii Dzieciecej
city: Szczecin
country: Poland
facility: SPSZOZ Zdroje Oddzial Pediatrii; Nefrologii i Toksykologii ze Stacja Dializ
city: Torun
country: Poland
facility: Wojewodzki Szpital Dzieciecy; Osrodek Chorob Nerek i Dializoterapii
city: Warszawa
country: Poland
facility: Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego
city: Wroclaw
country: Poland
facility: Akademia Medyczna im. Piastow Slaskich; Katedra i Klinika Nefrologii Pediatrycznej
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Iasi
country: Romania
facility: St. Maria Emergency Clinical Hospital for Children
city: Moscow
country: Russian Federation
facility: DGCB St. Vladimir; Pediatric nephrologist
city: Saint-Petersburg
country: Russian Federation
facility: SBIH Children City Hospital #1; Dialysis department
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz: Nefrologia Pediatrica
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Nefrologia Pediatrica
city: Bangkok
country: Thailand
facility: Chulalongkorn university Faculty of Medicine;Department of Pediatrics
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Faculty of Medicine; Department of Pediatrics
city: Kiev
country: Ukraine
facility: Kiev city childrens nephrological center of hospital #1; Nephrology and RRT
city: Zaporizhzhia
country: Ukraine
facility: Public Institution Zaporizhzhia City Multispecialty Children's Hospital #5; Allergologic
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: