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NCT Number: NCT02042833

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Relative importance for patients of different attributes of ESA treatment, assessed by Choice Based Conjoint questionnaire at baseline and Month 6

    Time frame: 6 months

Secondary outcomes

  1. Biological parameters: hemoglobin concentration at each observation time point.

    Time frame: 6 months

  2. Adherence to Mircera treatment assessed by a questionnaire adapted from the Morisky scale at baseline and at Month 6

    Time frame: 6 months

  3. Dose/schedule of Mircera treatment at each observation timepoint

    Time frame: 6 months

  4. Concomitant medication/treatments in the management of anemia

    Time frame: 6 months

  5. Proportion of patients with a hemoglobin level between 10 and 12 g/dL after 6 months of treatment with Mircera

    Time frame: Month 6

  6. Change in hemoglobin level

    Time frame: from baseline to Month 6

  7. Safety: Incidence of adverse events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 23, 2014
Registry last updated
Nov 3, 2015

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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