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)

Completed

• Conditions: Renal Anemia of Chronic Kidney Disease
• Interventions: Drug: Methoxy Polyethylene Glycol-Epoetin Beta

• Registration Number: NCT01756612
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-21
• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-27
• Primary Completion: 2015-03-25
• Study Completion: 2015-03-25
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 551

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Kidney Disease Participants	Methoxy Polyethylene Glycol-Epoetin Beta	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.

Primary Outcome Measures

Name	Time	Method
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	Baseline, Month 9

Secondary Outcome Measures

Name	Time	Method
Hemoglobin Levels According to Liu Index and Resistance Factors	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9
Average Dose of Mircera in Total Population	Baseline up to 9 months
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Total Population	Baseline up to 9 months
Average Dose of Mircera in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation	Baseline up to 9 months
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	Baseline up to 9 months
Duration of Treatment With Mircera	Baseline up to 9 months
Number of Participants Who Received Concomitant Treatment (Known as Potentially Resistant Factors) for Renal Anemia	Baseline up to 9 month

Trial Locations

Locations (105)

CHP Aix; 🇫🇷 Aix En Provence, France

Ch Notre Dame Misericorde; Hemodialyse; 🇫🇷 Ajaccio, France

Chi D Alencon;Nephrologie Hemodialyse; 🇫🇷 Alencon, France

Centre Aider; 🇫🇷 Ales, France

Hotel Dieu; Nephrologie Hemodialyse; 🇫🇷 Angers, France

Centre Hospitalier; Hemodialyse; 🇫🇷 Cholet, France

Centre Hemodialyse La Riviera; 🇫🇷 Antibes, France

Ch D Arras; Nephrologie; 🇫🇷 Arras, France

Chp Aubagne; 🇫🇷 Aubagne, France

Ch Henri Duffaut; Nephrologie Hemodialyse; 🇫🇷 Avignon, France

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