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A Study of Mircera in Renal Anemia Among Filipino Chronic Kidney Disease Patients

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ClinicalTrials.gov Identifier: NCT00922610
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess the efficacy and safety of once monthly administration of Mircera in Filipino patients with chronic kidney disease who are either on dialysis or predialysis, and not receiving erythropoiesis stimulating agents.Patients will receive Mircera at a starting dose of 0.6 micrograms/kg sc every 2 weeks, with dose adjustments until a target hemoglobin level is achieved, and then dosing will continue every 4 weeks. The anticipated time on study treatment is 3-12 months, and the target sample is <100 individuals.

Condition or disease Intervention/treatment Phase
Anemia Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of the Effect of Mircera on Hemoglobin Levels in Filipino Chronic Kidney Disease Patients
Study Start Date : February 2009
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
sc every 2 weeks at a starting dose of 0.6micrograms/kg;subsequently every 4 weeks


Outcome Measures

Primary Outcome Measures :
  1. Increase in Hb >1.0g/dL from baseline, and Hb conc. >11g/dL without red blood cell transfusion, for dialysis patients;Hb conc >11-12 g/dL for pre-dialysis patients [ Time Frame: 24 weeks after first dose, through week 25 ]

Secondary Outcome Measures :
  1. >=60% responders with target Hb >11g/dL for dialysis patients; Hb conc >11-12g/dL for pre-dialysis patients;incidence of RBC transfusions; no. of patients with dose adjustments [ Time Frame: At end of 24 weeks treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic kidney disease;
  • anemia (Hb >8 and <11 g/dL);
  • regular dialysis or predialysis, not treated with ESA.

Exclusion Criteria:

  • transfusion of red blood cells during previous 8 weeks;
  • poorly controlled hypertension;
  • overt gastrointestinal bleeding, or other bleeding necessitating transfusion during previous 8 weeks;
  • active malignant disease (except melanoma of skin).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922610


Locations
Philippines
Cavite, Philippines, 4103
Makati City, Philippines, 1229
Manila, Philippines, 1000
Marikina, Philippines, 1805
Pasig City, Philippines, 1605
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00922610     History of Changes
Other Study ID Numbers: ML21983
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency