Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 3, 2018

Primary Completion Date

July 19, 2021

Study Completion Date

July 19, 2021

Conditions
AnemiaRenal Insufficiency, Chronic
Interventions
DRUG

Mircera

The initial dose of Mircera will be one of nine starting doses corresponding to the prefilled syringe strengths based on the total weekly erythropoiesis-stimulating agent (ESA) dose during the screening period.

Trial Locations (22)

1083

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

4032

Debreceni Egyetem Klinikai Központ; Gyermekklinika, Debrecen

10126

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

20122

Clinica Pediatrica II De Marchi, Milan

27834

East Carolina University; Brody School of Medicine, Greenville

30322

Emory University School of Med; Pediatrics, Atlanta

35233

University of Alabama at Birmingham; Pediatric Nephrology, Birmingham

41013

Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica, Seville

59037

Hopital Jeanne De Flandre; Pediatrie, Lille

64108

Children'S Mercy Hospital; Pediatric Nephrology, Kansas City

67098

Höpital Hautepierre; Pediatrie 1, Strasbourg

75390

UT Southwestern Medical Center; Pediatrics Dept., Dallas

75743

Gh Necker Enfants Malades; Nephrologie, Paris

92354

Loma Linda University health, Loma Linda

07052

RWJBarnabas Health, West Orange

LT-08406

Vilnius University Children's Hospital, Vilnius

80-952

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

30-663

Uniwersytecki Szpital Dziecięcy w Krakowie; Oddz.Nefrologii i Nadciśnienia Tętniczego/Stacja Dializ, Krakow

93-338

"Instytut Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii", Lodz

87-100

Szpital Specjalistyczny dla Dzieci i Doroslych; Oddzial Kliniczny Pediatrii i Nefrologii, Torun

41-800

Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdziałem Dializoterapii, Zabrze

08035

Hospital Universitari Vall d'Hebron; Servicio de Nefrologia, Barcelona

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03552393 - Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis. | Biotech Hunter | Biotech Hunter