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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02042833

Enrollment

815

Registered

2014-01-23

Start date

2011-05-31

Completion date

2012-06-30

Last updated

2015-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Concomitant medication/treatments in the management of anemia	6 months
Biological parameters: hemoglobin concentration at each observation time point.	6 months
Change in hemoglobin level	from baseline to Month 6
Safety: Incidence of adverse events	6 months
Proportion of patients with a hemoglobin level between 10 and 12 g/dL after 6 months of treatment with Mircera	Month 6

Countries

France

Outcome results