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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00717366
First received: July 16, 2008
Last updated: July 1, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in Hb concentration between baseline and evaluation period [ Time Frame: Weeks 17-20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with average Hb concentration above, below or within range of 10-12g/dL during evaluation period [ Time Frame: Weeks 17-20 ] [ Designated as safety issue: No ]
  • Incidence of RBC transfusions, reticulocyte counts, adverse events, laboratory parameters [ Time Frame: Throughout study, up to 1 year ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: July 2008
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Intermediate starting dose iv weekly, based on previous weekly epoetin dose
Experimental: 2 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
High or low dose iv weekly, based on previous weekly epoetin dose

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717366

  Show 39 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00717366     History of Changes
Other Study ID Numbers: NH19707  2007-007758-70 
Study First Received: July 16, 2008
Last Updated: July 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on September 26, 2016