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

• Register: EUCTR
• Last refreshed on: 18 April 2016
• Main ID: EUCTR2007-007758-70-HU
• Date of registration: 01/07/2008
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: A Study of Intravenous Mircera for the Treatment of Anemia in Pediatric Patients on Hemodialysis.
• Scientific 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 patients with chronic kidney disease on hemodialysis. - DOLPHIN
• Date of first enrolment: 18/10/2008
• Target sample size: 68
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007758-70
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Belgium, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, Spain, Thailand, Ukraine

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Anemia associated with chronic kidney disease in pediatric patients (CKD) on hemodialysis
MedDRA version: 17.0 Level: LLT Classification code 10058124 Term: Nephrogenic anemia System Organ Class: 100000004851

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Intervention(s)

Trade Name: MIRCERA®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methoxy polyethylene glycol-epoetin beta
CAS Number: 677324-53-7
Current Sponsor code: RO0503821
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30/0.3-

Trade Name: MIRCERA®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methoxy polyethylene glycol-epoetin beta
CAS Number: 677324-53-7
Current Sponsor code: RO0503821
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 50/0.3-

Trade Name: MIRCERA®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methoxy polyethylene glycol-epoetin beta
CAS Number: 677324-53-7
Current Sponsor code: RO0503821
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 75/0.3-

Trade Name: MIRCERA®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methoxy polyethylene glycol-epoetin beta
CAS Number: 677324-53-7
Current Sponsor code: RO0503821
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 120/0.3-

Trade Name: MIRCERA®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methoxy polyethylene glycol-epoetin beta
CAS Number: 677324-53-7
Current Sponsor code: RO0503821
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 200/0.3-

Trade Name: MIRCERA®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methoxy polyethylene glycol-epoetin beta
CAS Number: 677324-53-7
Current Sponsor code: RO0503821
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 360/0.6-

Primary Outcome(s)

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
- 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
- To explore MIRCERA® exposure response relationship
- To assess the safety and tolerability of multiple doses of MIRCERA® in pediatric patients
- To document long-term safety and efficacy of MIRCERA® administration in pediatric patients with anemia associated with CKD

Timepoint(s) of evaluation of this end point: Weeks 17-20

Primary end point(s): - Change in Hb concentration between baseline and evaluation period.

Secondary Outcome(s)

Secondary end point(s): 1. Incidence of RBC transfusions, reticulocyte counts, adverse events, laboratory parameters.

2. Number of patients with average Hb concentration above, below or within range of 10-12g/dL during evaluation period.

Timepoint(s) of evaluation of this end point: 1. Throughout study, up to 1 year

2. Weeks 17-20

Secondary ID(s)

2007-007758-70-BE

NH19707

NCT00717366

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd