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Completed

NCT Number: NCT01756612

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 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.

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Key information

Conditions

Renal Anemia of Chronic Kidney Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHP Aix, Aix-en-Provence, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methoxy polyethylene glycol-epoetin beta

Drug

Methoxy polyethylene glycol-epoetin beta will be administered at the discretion of treating physician. Study protocol does not specify any treatment regimen.

Other names: Mircera

Primary outcomes

  1. 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

Secondary outcomes

  1. Hemoglobin Levels According to Liu Index and Resistance Factors

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9

  2. Average Dose of Mircera in Total Population

    Time frame: Baseline up to 9 months

  3. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Total Population

    Time frame: Baseline up to 9 months

  4. 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

  5. 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

  6. Duration of Treatment With Mircera

    Time frame: Baseline up to 9 months

  7. Number of Participants Who Received Concomitant Treatment (Known as Potentially Resistant Factors) for Renal Anemia

    Time frame: Baseline up to 9 month

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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®

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 27, 2012
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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