A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01342640
First received: April 20, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This single arm, open label, multicenter study will evaluate the safety and chan ge in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoeti n beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneo usly every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. T he anticipated time on study treatment is 28 weeks.


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: A Single Arm, Open Label, Multicenter Phase IIIb/IV Clinical Trial to Assess the Efficacy, Safety and Tolerability of Monthly Administration of C.E.R.A. for the Treatment of Not on Dialysis Chronic Renal Anemia Not Currently Treated With ESA

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in hemoglobin concentration [ Time Frame: Week 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: July 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.

  Eligibility

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

Inclusion Criteria:

  • Adult patients, age >/=18 years
  • Diagnosis of chronic renal anemia
  • Not on dialysis
  • Hemoglobin concentration <10 g/dl
  • No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start
  • Estimated glomerular filtration rate (EGFR) <60 ml/min and >/=20 ml/min
  • Adequate iron status

Exclusion Criteria:

  • Transfusion of red blood cells during the previous 2 months
  • Poorly controlled hypertension
  • Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
  • Active malignant disease (except non-melanoma skin cancer)
  • Hemolysis
  • Hemoglobinopathies, e.g. sickle-cell disease, thalassemia
  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: NCT01342640

Locations
Egypt
Alexandria, Egypt
Cairo, Egypt
Mansoura, Egypt, 0
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: NCT01342640     History of Changes
Other Study ID Numbers: ML25300
Study First Received: April 20, 2011
Last Updated: August 4, 2014
Health Authority: Egypt: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014