Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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18 April 2016 |
Main ID: |
EUCTR2007-007758-70-DE |
Date of registration:
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15/05/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of Intravenous Mircera for the Treatment of Anemia in Pediatric Patients on Hemodialysis.
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Scientific title:
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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:
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15/09/2008 |
Target sample size:
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68 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007758-70 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Australia
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Belgium
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France
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Germany
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Hungary
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Italy
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Poland
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Romania
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Russian Federation
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Spain
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Thailand
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Ukraine
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Contacts
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F. Hoffmann-La Roche Ltd |
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F. Hoffmann-La Roche Ltd |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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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
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Intervention(s)
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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-
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Primary Outcome(s)
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Primary end point(s): - Change in Hb concentration between baseline and evaluation period.
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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®
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Timepoint(s) of evaluation of this end point: Weeks 17-20
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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
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Secondary Outcome(s)
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Secondary end point(s): 1. Incidence of RBC transfusions, reticulocyte counts, AEs, laboratory parameters.
2. Number of patients with average Hb concentration above, below or within range of 10-12g/dL during evaluation period.
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Timepoint(s) of evaluation of this end point: 1. Throughout study, up to 1 year
2. Weeks 17-20
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Secondary ID(s)
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NCT00717366
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2007-007758-70-BE
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NH19707
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Source(s) of Monetary Support
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F. Hoffmann-La Roche Ltd.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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