An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01695746
First received: September 27, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic k idney disease patients not on dialysis receiving Mircera for the treatment of ch ronic renal anemia. Eligible patients will be followed for 24 weeks.


Condition
Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients in Stage III - IV , Not on Dialysis , Treated According to Routine Clinical Practice

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Clinical/demographic patient characteristics at initiation of treatment with Mircera [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Mean time to achieve target Hb range (Hb 10-12 g/dL) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Maintenance of Hb levels (patients on ESA with HB 10-12 g/dL): Percentage of patients maintaining Hb level within 1 g/dL of baseline during study period (24 weeks) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients achieving Hb target range (Hb 10-12 g/dL) at least once during study treatment [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Maintenance: Mean time spent on Hb level 10-12 g/dL) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Dosage/administration route [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: October 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with stage III-IV chronic kidney disease not on dialysis receiving treatment with Mircera for chronic renal anemia

Criteria

Inclusion Criteria:

  • Adult patients, 18 to 65 years of age, inclusive
  • Patients with stage III-IV chronic kidney disease not on dialysis
  • ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
  • Adequate iron status as judged by the treating physician

Exclusion Criteria:

  • Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
  • Clinically significant concomitant disease or disorder as defined by protocol
  • Clinical suspicion of pure red cell aplasia (PRCA)
  • Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
  • Transfusion of red blood cells in the previous 2 months
  • Pregnant women
  • Contraindications for Mircera according to local prescribing information or as judged by the investigator
  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: NCT01695746

Locations
India
Bhubaneswar, India, 751021
Hyderabad, India, 500 029
Mumbai, India, 400012
Mumbai, India, 400036
Vadodara, India, 390005
Vellore, India, 632006
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: NCT01695746     History of Changes
Other Study ID Numbers: ML25476
Study First Received: September 27, 2012
Last Updated: August 4, 2014
Health Authority: India: Drug Controller General

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014