Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis

NCT ID: NCT00717366

Last Updated: 2017-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2016-03-31

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.

Conditions

Renal Anemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Methoxy Polyethylene Glycol-Epoetin Beta

Intervention Type: DRUG

Will be administered IV, every 4 weeks.

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.

Group Type: EXPERIMENTAL

Methoxy Polyethylene Glycol-Epoetin Beta

Intervention Type: DRUG

Will be administered IV, every 4 weeks.

Interventions

Methoxy Polyethylene Glycol-Epoetin Beta

Will be administered IV, every 4 weeks.

Intervention Type: DRUG

Other Intervention Names

MIRCERA; RO0503821

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Royal Children'S Hospital; Department of Nephrology

Parkville, Victoria, Australia

Hôpital Enfants Reine Fabiola

Brussels, , Belgium

UZ Leuven Gasthuisberg

Leuven, , Belgium

Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie

Bron, , France

Hopital Jeanne De Flandre; Cons Pediatrie

Lille, , France

Hopital Timone Enfants; Nephrologie Hemodialyse

Marseille, , France

Hopital Arnaud De Villeneuve; Pediatrie I

Montpellier, , France

Hôpital Robert Debré; Nephrologie pediatrique

Paris, , France

Hopital Armand Trousseau; Pediatrie Nephrologie

Paris, , France

Höpital Hautepierre; Pediatrie 1

Strasbourg, , France

Klinik der Uni zu Köln; Kinderklinik

Cologne, , Germany

KfH Nierenzentrum für Kinder und Jugendliche

Hamburg, , Germany

KfH-Nierenzentrum fur Kinder und Jugendliche

Heidelberg, , Germany

Kinderklinik Memmingen; Kinderdialysezentrum

Memmingen, , Germany

KfH-Nierenzentrum für Kinder und Jugendliche

Münster, , Germany

Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center

Budapest, , Hungary

Ospedale Pediatrico Bambino Gesu; U.O. Di Nefrologia E Dialisi

Rome, Lazio, Italy

IRCCS G. Gaslini; U.O. Nefrologia, Dialisi e Trapianto

Genoa, Liguria, Italy

Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto

Turin, Piedmont, Italy

A.O. Di Padova; Dipartimento Di Pediatria U.O. Di Nefrologia Pediatrica, Dialisi e Trapianto

Padua, Veneto, Italy

Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy

Gdansk, , Poland

Instytut "Centrum Zdrowia Matki Polki; Klinika Nefrologii i Dializoterapii

Lodz, , Poland

Dzieciecy Szpital Kliniczny; Klinika Nefrologii Dzieciecej

Lublin, , Poland

SPSZOZ Zdroje Oddzial Pediatrii; Nefrologii i Toksykologii ze Stacja Dializ

Szczecin, , Poland

Wojewodzki Szpital Dzieciecy; Osrodek Chorob Nerek i Dializoterapii

Torun, , Poland

Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego

Warsaw, , Poland

Akademia Medyczna im. Piastow Slaskich; Katedra i Klinika Nefrologii Pediatrycznej

Wroclaw, , Poland

Fundeni Clinical Institute

Bucharest, , Romania

St. Maria Emergency Clinical Hospital for Children

Iași, , Romania

DGCB St. Vladimir; Pediatric nephrologist

Moscow, , Russia

SBIH Children City Hospital #1; Dialysis department

Saint Petersburg, , Russia

Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

Barcelona, , Spain

Hospital Universitario La Paz: Nefrologia Pediatrica

Madrid, , Spain

Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica

Seville, , Spain

Hospital Universitario la Fe; Servicio de Nefrologia Pediatrica

Valencia, , Spain

Chulalongkorn university Faculty of Medicine;Department of Pediatrics

Bangkok, , Thailand

Siriraj Hospital, Faculty of Medicine; Department of Pediatrics

Bangkok, , Thailand

Kiev city childrens nephrological center of hospital #1; Nephrology and RRT

Kiev, , Ukraine

Public Institution Zaporizhzhia City Multispecialty Children's Hospital #5; Allergologic

Zaporizhzhia, , Ukraine

Countries

Australia; Belgium; France; Germany; Hungary; Italy; Poland; Romania; Russia; Spain; Thailand; Ukraine

Other Identifiers

2007-007758-70

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NH19707

Identifier Type: -

Identifier Source: org_study_id