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COMETE Study: Comorbidity Mircera Evolution of Hemoglobin Rate; A Non-Interventional Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01756612
First received: December 19, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This prospective, multicenter, observational study will evaluate the impact of comorbidity factors on the hemoglobin level in patients with chronic kidney disease not on dialysis who are initiated on treatment with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from patients for 9 months after initiation of Mircera treatment.


Condition
Kidney Disease, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non Interventional Study to Assess the Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CDK) Patients Not in Dialysis Treated With Mircera

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients with an increase in hemoglobin level of >/= 1g/dL or a hemoglobin level between 10 and 12 g/dL after 9 months of treatment without any transfusional recourse (total population and comorbidity subgroups) [ Time Frame: approximately 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: approximately 9 months ] [ Designated as safety issue: No ]
  • Hemoglobin levels according to Liu Index and resistance factors [ Time Frame: approximately 9 months ] [ Designated as safety issue: No ]
  • Mircera dosage [ Time Frame: approximately 9 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 540
Study Start Date: March 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

  Eligibility

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

Patients with chronic kidney disease not on dialysis and ESA naïve

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with chronic kidney disease not on dialysis
  • Treatment-naïve for ESAs (not having received ESAs in the 6 months prior to inclusion in this study)
  • Hemoglobin level < 10 g/dL at inclusion
  • Patients for whom the treating physician has decided to initiate treatment with Mircera for medical reasons prior to study start

Exclusion Criteria:

  • Functional renal transplant
  • Current participation in a clinical trial in anemia due to chronic kidney disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756612

Contacts
Contact: Please reference Study ID Number: ML28145 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 110 Study Locations
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: NCT01756612     History of Changes
Other Study ID Numbers: ML28145
Study First Received: December 19, 2012
Last Updated: May 7, 2013
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Chronic Disease
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Disease Attributes
Pathologic Processes
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 21, 2013