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

NCT00717366 | Completed Phase 2 Results

• 2 other identifiers: NH197072007-007758-70
• Study Type: interventional
• Target: 64
• Locations: 12 countries
• Sites: 39

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

Outcome Measures

Primary Outcomes (1)

• Change in Average Hb Concentration Between Baseline and Evaluation Period

  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.

  Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)

Secondary Outcomes (8)

• Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb

  Evaluation Period (Week 17 to Week 21)

• Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL

  Evaluation Period (Week 17 to Week 21)

• Number of Participants With Blood Transfusions

  Baseline to Week 20

• Change in Average Reticulocyte Count Between the Baseline and Evaluation Period

  Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)

• Maximum Observed Serum Concentration (Cmax) of MIRCERA

  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

Study Arms (2)

MIRCERA Group 1: Intermediate-Conversion-Factor Group

EXPERIMENTAL

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.

Drug: Methoxy Polyethylene Glycol-Epoetin Beta

MIRCERA Group 2: High-Conversion-Factor Group

EXPERIMENTAL

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.

Drug: Methoxy Polyethylene Glycol-Epoetin Beta

Interventions

Methoxy Polyethylene Glycol-Epoetin Beta DRUG

Will be administered IV, every 4 weeks.

Also known as: MIRCERA, RO0503821

MIRCERA Group 1: Intermediate-Conversion-Factor Group; MIRCERA Group 2: High-Conversion-Factor Group

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (39)

Royal Children'S Hospital; Department of Nephrology

Parkville, Victoria, 3052, Australia

Location

Hôpital Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie

Bron, 69677, France

Location

Hopital Jeanne De Flandre; Cons Pediatrie

Lille, 59037, France

Location

Hopital Timone Enfants; Nephrologie Hemodialyse

Marseille, 13385, France

Location

Hopital Arnaud De Villeneuve; Pediatrie I

Montpellier, 34295, France

Location

Hôpital Robert Debré; Nephrologie pediatrique

Paris, 75019, France

Location

Hopital Armand Trousseau; Pediatrie Nephrologie

Paris, 75571, France

Location

Höpital Hautepierre; Pediatrie 1

Strasbourg, 67098, France

Location

Klinik der Uni zu Köln; Kinderklinik

Cologne, 50937, Germany

Location

KfH Nierenzentrum für Kinder und Jugendliche

Hamburg, 20246, Germany

Location

KfH-Nierenzentrum fur Kinder und Jugendliche

Heidelberg, 69120, Germany

Location

Kinderklinik Memmingen; Kinderdialysezentrum

Memmingen, 87700, Germany

Location

KfH-Nierenzentrum für Kinder und Jugendliche

Münster, 48149, Germany

Location

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

Budapest, 1083, Hungary

Location

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

Rome, Lazio, 00165, Italy

Location

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

Genoa, Liguria, 16148, Italy

Location

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

Turin, Piedmont, 10126, Italy

Location

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

Padua, Veneto, 35128, Italy

Location

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

Gdansk, 80-294, Poland

Location

Instytut "Centrum Zdrowia Matki Polki; Klinika Nefrologii i Dializoterapii

Lodz, 93-338, Poland

Location

Dzieciecy Szpital Kliniczny; Klinika Nefrologii Dzieciecej

Lublin, 20-093, Poland

Location

SPSZOZ Zdroje Oddzial Pediatrii; Nefrologii i Toksykologii ze Stacja Dializ

Szczecin, 70-410, Poland

Location

Wojewodzki Szpital Dzieciecy; Osrodek Chorob Nerek i Dializoterapii

Torun, 87-100, Poland

Location

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

Warsaw, 04-730, Poland

Location

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

Wroclaw, 50-369, Poland

Location

Fundeni Clinical Institute

Bucharest, 022328, Romania

Location

St. Maria Emergency Clinical Hospital for Children

Iași, 700309, Romania

Location

DGCB St. Vladimir; Pediatric nephrologist

Moscow, 107014, Russia

Location

SBIH Children City Hospital #1; Dialysis department

Saint Petersburg, 198205, Russia

Location

Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

Barcelona, 08035, Spain

Location

Hospital Universitario La Paz: Nefrologia Pediatrica

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica

Seville, 41013, Spain

Location

Hospital Universitario la Fe; Servicio de Nefrologia Pediatrica

Valencia, 46009, Spain

Location

Chulalongkorn university Faculty of Medicine;Department of Pediatrics

Bangkok, 10310, Thailand

Location

Siriraj Hospital, Faculty of Medicine; Department of Pediatrics

Bangkok, 10700, Thailand

Location

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

Kiev, 04209, Ukraine

Location

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

Zaporizhzhia, 69076, Ukraine

Location

MeSH Terms

Interventions

continuous erythropoietin receptor activator

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 17, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 8, 2017
• Results First Posted: September 8, 2017

Record last verified: 2017-08

Locations

DE (5); PL (7); ES (4); BE (2); RO (2); HU (1); IT (4); RU (2); FR (7); AU (1); TH (2); UA (2)