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

Anemia Clinical Trial

Official 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 Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717366
• Other study ID #: NH19707
• Secondary ID: 2007-007758-70
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2008
• Last updated: July 1, 2016
• Start date: July 2008
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This sequential study will assess the efficacy and safety of multiple doses of intravenous Mircera, and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric patients will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive intravenous 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. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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.

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
Intermediate starting dose iv weekly, based on previous weekly epoetin dose
• methoxy polyethylene glycol-epoetin beta [Mircera]
High or low dose iv weekly, based on previous weekly epoetin dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hb concentration between baseline and evaluation period		Weeks 17-20	No
Secondary	Number of patients with average Hb concentration above, below or within range of 10-12g/dL during evaluation period		Weeks 17-20	No
Secondary	Incidence of RBC transfusions, reticulocyte counts, adverse events, laboratory parameters		Throughout study, up to 1 year	No