Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 Identifier:
First received: June 16, 2009
Last updated: February 5, 2015
Last verified: February 2015

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
Intervention Model: Single Group Assignment
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
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 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

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT00922610     History of Changes
Other Study ID Numbers: ML21983
Study First Received: June 16, 2009
Last Updated: February 5, 2015
Health Authority: Philippines: Department of Health

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases processed this record on March 01, 2015