A Study of Intravenous Mircera for the Treatment of Anemia in Pediatric Patients on Hemodialysis.

• Conditions: Anemia associated with chronic kidney disease in pediatric patients (CKD) on hemodialysis; MedDRA version: 17.0Level: LLTClassification code 10058124Term: Nephrogenic anemiaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2007-007758-70-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-15
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

- written informed consent from parent/legal guardian and/or assent
from child where appropriate as required by national legislation
- children aged 5-17 years (in Russia only: 12-17 years) with clinically
stable chronic renal anemia;
- hemodialysis for >=8 weeks;
- intravenous stable maintenance epoetin alfa, epoetin beta or
darbepoetin alfa for >= 8 weeks before screening and with no weekly
dose change >/=25% (increase or decrease) during the 2 weeks of
screening.
Are the trial subjects under 18? yes
Number of subjects for this age range: 68
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- overt gastrointestinal bleeding, or bleeding episode necessitating
transfusion within 8 weeks before screening;
- red blood cell (RBC) transfusions within 8 weeks before screening;
- active malignant disease;
- pure red cell aplasia (PRCA) or history of PRCA;
- pregnant or lactating;
- for sexually active patients: not willing to use reliable contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To determine the starting dose of MIRCERA® in pediatric patients with CKD on hemodialysis when switching from stable maintenance treatment with epoetin alfa, epoetin beta or darbepoetin alfa<br>- To demonstrate changes in Hb over time in response to different iv doses of MIRCERA®;Secondary Objective: - To study the pharmacokinetics (PK) of MIRCERA® in pediatric patients<br>- To explore MIRCERA® exposure response relationship<br>- To assess the safety and tolerability of multiple doses of MIRCERA® in pediatric patients<br>- To document long-term safety and efficacy of MIRCERA® administration in pediatric patients with anemia associated with CKD;Primary end point(s): - Change in Hb concentration between baseline and evaluation period.;Timepoint(s) of evaluation of this end point: Weeks 17-20

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1. Throughout study, up to 1 year<br>2. Weeks 17-20;Secondary end point(s): 1. Incidence of RBC transfusions, reticulocyte counts, AEs, laboratory parameters.<br>2. Number of patients with average Hb concentration above, below or within range of 10-12g/dL during evaluation period.