Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study to Assess Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Participants Not in Dialysis Treated With Methoxy Polyethylene Glycol-Epoetin Beta (COMETE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01756612
First received: December 19, 2012
Last updated: November 2, 2016
Last verified: November 2016
  Purpose
This prospective, multicenter, observational study will evaluate the impact of comorbidity factors on the hemoglobin level in participants with chronic kidney disease who are not on dialysis and initiated on treatment with methoxy polyethylene glycol-epoetin beta (Mircera). Data will be collected for 9 months after initiation of methoxy polyethylene glycol-epoetin beta treatment.

Condition Intervention
Renal Anemia of Chronic Kidney Disease
Drug: Methoxy Polyethylene Glycol-Epoetin Beta

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 (CKD) Patients Not in Dialysis Treated With Mircera®

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With an Increase From Baseline in Hemoglobin Level of Greater Than or Equal to (>/=) 1 g/dL or a Hemoglobin Level Between 10 and 12 g/dL After 9 Months of Treatment Without any Transfusional Recourse [ Time Frame: Baseline, Month 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemoglobin Levels According to Liu Index and Resistance Factors [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9 ] [ Designated as safety issue: No ]
  • Average Dose of Mircera in Total Population [ Time Frame: Baseline up to 9 months ] [ Designated as safety issue: No ]
  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Total Population [ Time Frame: Baseline up to 9 months ] [ Designated as safety issue: No ]
  • Average Dose of Mircera in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation [ Time Frame: Baseline up to 9 months ] [ Designated as safety issue: No ]
  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation [ Time Frame: Baseline up to 9 months ] [ Designated as safety issue: No ]
  • Duration of Treatment With Mircera [ Time Frame: Baseline up to 9 months ] [ Designated as safety issue: No ]
  • Number of Participants Who Received Concomitant Treatment (Known as Potentially Resistant Factors) for Renal Anemia [ Time Frame: Baseline up to 9 month ] [ Designated as safety issue: No ]

Enrollment: 551
Study Start Date: November 2012
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic Kidney Disease Participants
Participants for whom the treating physician has decided to initiate treatment with MIRCERA for medical reasons prior to study start, will be observed for 9 months.
Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Methoxy polyethylene glycol-epoetin beta will be administered at the discretion of treating physician. Study protocol does not specify any treatment regimen.
Other Name: Mircera

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ESA naïve participants with chronic kidney disease who are not on dialysis
Criteria

Inclusion Criteria:

  • Participants with chronic kidney disease not on dialysis
  • Treatment-naïve for erythropoiesis-stimulating agents (ESAs), not having received ESAs in the 6 months prior to inclusion in this study
  • Hemoglobin level less then (<)10 grams per deciliter (g/dL) at inclusion
  • Participants for whom the treating physician has decided to initiate treatment with methoxy polyethylene glycol-epoetin beta 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
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: NCT01756612

  Show 105 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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: November 2, 2016
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on December 07, 2016