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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00922610
First received: June 16, 2009
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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 dial ysis or predialysis, and not receiving erythropoiesis stimulating agents.Patient s 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 dos ing 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
Anemia
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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: July 7, 2014
Health Authority: Philippines: Department of Health

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

ClinicalTrials.gov processed this record on July 29, 2014