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: April 7, 2014
Last verified: April 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 kidney disease patients not on dialysis receiving Mircera for the treatment of chronic 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
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: April 7, 2014
Health Authority: India: Drug Controller General

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

ClinicalTrials.gov processed this record on April 17, 2014