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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: June 16, 2009
Last updated: May 4, 2016
Last verified: May 2016
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 Intervention Phase
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • >=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 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: February 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00922610

Cavite, Philippines, 4103
Makati City, Philippines, 1229
Manila, Philippines, 1000
Marikina, Philippines, 1805
Pasig City, Philippines, 1605
Sponsors and Collaborators
Hoffmann-La Roche
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 
Study First Received: June 16, 2009
Last Updated: May 4, 2016
Health Authority: Philippines: Department of Health

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

ClinicalTrials.gov processed this record on May 22, 2016