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AnemiaNCT02042833

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

An observational study of Anemia, run by Hoffmann-La Roche at 109 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
How many people
815 participants
Where
109 sitesFrance
Study dates
May 2011to Jun 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with chronic kidney disease not on dialysis (with or without previous renal transplantation), initiating treatment with Mircera, and erythropoiesis-stimulating agent (ESA)-naïve or not

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

109 sites in 1 country.

109 sites in 1 country

France109 sites

  • Study site

    Aix-en-Provence, 13100

  • Study site

    Ajaccio, 20303

  • Study site

    Annonay, 07103

  • Study site

    Arras, 62022

  • Study site

    Avignon, 84000

  • Study site

    Bagnols-sur-Cèze, 30200

  • Study site

    Bayonne, 64109

  • Study site

    Beauvais, 60021

  • Study site

    Belley, 01300

  • Study site

    Besançon, 25030

  • Study site

    Bièvres, 91570

  • Study site

    Bois-Guillaume, 76233

  • Study site

    Bordeaux, 33077

  • Study site

    Bourg-en-Bresse, 01012

  • Study site

    Bourgoin, 38317

  • Study site

    Brest, 29609

  • Study site

    Cabestany, 66330

  • Study site

    Caen, 14033

  • Study site

    Castelnau-le-Lez, 34170

  • Study site

    Chalon-sur-Saône, 71100

  • Study site

    Champigny-sur-Marne, 94507

  • Study site

    Charleville-Mézières, 08011

  • Study site

    Châteauroux, 36000

  • Study site

    Chaumont, 52001

  • Study site

    Clermont-Ferrand, 63003

  • Study site

    Colmar, 68024

  • Study site

    Creil, 60109

  • Study site

    Créteil, 94010

  • Study site

    Dijon, 21000

  • Study site

    Dijon, 21079

  • Study site

    Dole, 39108

  • Study site

    Draguignan, 83300

  • Study site

    Épinal, 88021

  • Study site

    Évian-les-Bains, 74500

  • Study site

    Évreux, 27023

  • Study site

    Freyming-Merlebach, 57804

  • Study site

    Gap, 05000

  • Study site

    Gradignan, 33171

  • Study site

    Greize, 69400

  • Study site

    Grenoble, 38028

  • Study site

    Haguenau, 67504

  • Study site

    La Chaussée-Saint-Victor, 41260

  • Study site

    La Roche-sur-Yon, 85925

  • Study site

    La Tronche, 38700

  • Study site

    La Tronche, 38701

  • Study site

    Laon, 02001

  • Study site

    Le Mans, 72037

  • Study site

    Le Mans, 72100

  • Study site

    Le Puy-en-Velay, 43012

  • Study site

    Lille, 59037

  • Study site

    Lille, 59042

  • Study site

    Lorient, 56322

  • Study site

    Lyon, 69008

  • Study site

    Mâcon, 71018

  • Study site

    Marseille, 13253

  • Study site

    Marseille, 13385

  • Study site

    Maubeuge, 59607

  • Study site

    Melun, 77011

  • Study site

    Metz, 57003

  • Study site

    Mont-de-Marsan, 40024

  • Study site

    Mont-Saint-Martin, 54350

  • Study site

    Montluçon, 03108

  • Study site

    Mullhouse, 68100

  • Study site

    Nancy, 54100

  • Study site

    Nantes, 44035

  • Study site

    Nantes, 44202

  • Study site

    Nice, 06002

  • Study site

    Nîmes, 30029

  • Study site

    Olivet, 45160

  • Study site

    Ollioules, 83190

  • Study site

    Orléans, 45000

  • Study site

    Orléans, 45100

  • Study site

    Paris, 75008

  • Study site

    Paris, 75011

  • Study site

    Paris, 75014

  • Study site

    Paris, 75230

  • Study site

    Paris, 75475

  • Study site

    Paris, 75651

  • Study site

    Paris, 75877

  • Study site

    Paris, 75908

  • Study site

    Paris, 75970

  • Study site

    Perpignan, 66046

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Poissy, 78303

  • Study site

    Poitiers, 86021

  • Study site

    Quimper, 29000

  • Study site

    Quimper, 29107

  • Study site

    Rambouillet, 78514

  • Study site

    Rennes, 35033

  • Study site

    Roanne, 42328

  • Study site

    Rodez, 12027

  • Study site

    Romans-sur-Isère, 26102

  • Study site

    Rouen, 76040

  • Study site

    Saint-Laurent-du-Var, 06700

  • Study site

    Saint-Laurent-du-Var, 06721

  • Study site

    Saint-Lô, 50009

  • Study site

    Saint-Priest-en-Jarez, 42277

  • Study site

    Saint-Quentin, 02321

  • Study site

    Salouël, 80480

  • Study site

    Sens, 89100

  • Study site

    Strasbourg, 67091

  • Study site

    Toulon, 83056

  • Study site

    Toulouse, 31059

  • Study site

    Tournan-en-Brie, 77220

  • Study site

    Tours, 37044

  • Study site

    Valenciennes, 59322

  • Study site

    Vandœuvre-lès-Nancy, 54511

  • Study site

    Vannes, 56017

  • Study site

    Vesoul, 70014

Other trials in France

About this study

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.

Conditions
Anemia
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02042833
Study groupRoleWhat they receive
CohortNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (7)

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

  4. Concomitant medication/treatments in the management of anemia

    Measured: 6 months

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

    Measured: Month 6

  6. Change in hemoglobin level

    Measured: from baseline to Month 6

  7. Safety: Incidence of adverse events

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2014 (estimated)
  2. Study startMay 2011
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
815 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02042833
Sponsor's protocol ID
ML25557
Status last verified
Nov 2015
First submitted
21 Jan 2014
Last updated
3 Nov 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia, run by Hoffmann-La Roche at 109 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02042833.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.

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