An Observational Study of Patients' Perception of Treatment With Erythropoiesis-Stimulating Agents in Patients With Chronic Kidney Disease Not on Dialysis (PERCEPOLIS)

Completed

• Conditions: Anemia

• Registration Number: NCT02042833
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational study will evaluate patients' perception of treatment with erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis. Eligible patients initiated on treatment with Mircera (methoxy polyethylene glycol-epoetin beta) will be followed for 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 815

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Patients with chronic kidney disease not on dialysis (with or without previous renal transplantation)
• Treated or not with ESA at time of visit
• Patients for whom the treating physician had decided to initiate Mircera for medical reasons before the commencement of the study
• Initiation of treatment with Mircera at the inclusion visit
• Accepting and able of completing the ESA preference questionnaire

Exclusion Criteria

• Participation in a clinical trial on anemia
• Treatment with Mircera during the 3 months before inclusion
• Dialysis planned in the next 6 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative importance for patients of different attributes of ESA treatment, assessed by Choice Based Conjoint questionnaire at baseline and Month 6	6 months

Secondary Outcome Measures

Name	Time	Method
Concomitant medication/treatments in the management of anemia	6 months
Change in hemoglobin level	from baseline to Month 6
Safety: Incidence of adverse events	6 months
Biological parameters: hemoglobin concentration at each observation time point.	6 months
Adherence to Mircera treatment assessed by a questionnaire adapted from the Morisky scale at baseline and at Month 6	6 months
Dose/schedule of Mircera treatment at each observation timepoint	6 months
Proportion of patients with a hemoglobin level between 10 and 12 g/dL after 6 months of treatment with Mircera	Month 6