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Renal Anemia of Chronic Kidney DiseaseNCT01756612

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)

An observational study of Renal Anemia of Chronic Kidney Disease, run by Hoffmann-La Roche at 108 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 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Anemia of Chronic Kidney Disease
What is being tested?
Methoxy Polyethylene Glycol-Epoetin Beta
How many people
551 participants
Where
108 sitesFrance
Study dates
21 Nov 2012to 25 Mar 2015
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: ESA naïve participants with chronic kidney disease who are not on dialysis

Who may be able to join

  • 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

Who cannot join

  • Functional renal transplant
  • Current participation in a clinical trial in anemia due to chronic kidney disease

Trial locations and contacts

108 sites in 1 country.

108 sites in 1 country

France108 sites

  • CHP Aix

    Aix-en-Provence, 13100

  • Ch Notre Dame Misericorde; Hemodialyse

    Ajaccio, 20303

  • Chi D Alencon;Nephrologie Hemodialyse

    Alençon, 61014

  • Centre Aider

    Alès, 30100

  • Hotel Dieu; Nephrologie Hemodialyse

    Angers, 49933

  • Centre Hospitalier; Hemodialyse

    Annonay, 07103

  • Centre Hemodialyse La Riviera

    Antibes, 06600

  • Ch D Arras; Nephrologie

    Arras, 62022

  • Chp Aubagne

    Aubagne, 13400

  • Ch Henri Duffaut; Nephrologie Hemodialyse

    Avignon, 84902

  • Chic Cote Basque Bayonne; Nephrologie Hemodialyse

    Bayonne, 64109

  • Ch De Beauvais; Neph Endocrino Dialyse Diabeto

    Beauvais, 60021

  • Centre D Hemodialyse Regina

    Belley, 01300

  • CHU Saint Jacques; Centre De Dialyse

    Besançon, 25030

  • Ch Germon Et Gauthier; Medecine Interne Nephrologie

    Beuvry, 62660

  • CNB - Centre Nephrologie Du Biterrois

    Béziers

  • Centre Hemodialyse St Augustin; Nephrologie

    Bordeaux, 33000

  • Hopital Pellegrin; Departement Nephrologie

    Bordeaux, 33076

  • Cabinet Medical

    Bordeaux, 33300

  • Ch De Fleyriat; Nephrologie Hemodialyse

    Bourg-en-Bresse, 01012

  • Aural; Service Hemodialyse

    Bourgoin, 38317

  • Hopital La Cavale Blanche; Nephrologie

    Brest, 29609

  • Ch de Brive la Gaillarde; Nephrologie Hemodialyse

    Brive-la-Gaillarde, 19312

  • Centre D Hemodialyse Saint Roch

    Cabestany, 66330

  • Hopital Clemenceau; Nephrologie Hemodialyse

    Caen, 14033

  • Ch Antoine Gayraud; Nephrologie Hemodialyse

    Carcassonne, 11890

  • Centre Hemodialyse Du Lez; Nephrologie

    Castelnau-le-Lez, 34170

  • CH William Morey; Nephrologie

    Chalon-sur-Saône, 71100

  • Aura Auvergne; Aura Auvergne

    Chamalières, 63400

  • Ch De Chambery; Nephrologie

    Chambéry, 73011

  • Avitum France; Centre De Nephrologie

    Châteauroux, 36000

  • Centre Hospitalier; Hemodialyse

    Cholet, 49300

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63003

  • Centre De Sante Medical; Centre De Sante Republique

    Clermont-Ferrand, 63100

  • Ch Laennec; Nephrologie Hemodialyse

    Creil, 60109

  • Fondation Transplantation; Ctirc De Drevon

    Dijon, 21000

  • Nephrocare Ile De France; Etampes

    Étampes, 91150

  • Chi Eure Seine D Evreux; Nephrologie

    Évreux, 27023

  • Cabinet Medical

    Fontaine-lès-Dijon, 21121

  • Hopital De Freyming; Nephrologie

    Freyming-Merlebach, 57804

  • Centre Hospitalier General; Service de Nephrologie-Hemodialyse

    Gap, 05000

  • Association Aurad Aquitaine; Aurad Gradignan

    Gradignan, 33171

  • Centre de Dialyse Atirra; Service Nephrologie - Hemodialyse

    Greize, 69400

  • Ch Dptal Les Oudairies; Nephrologie

    La Roche-sur-Yon, 85925

  • Hopital Albert Michallon; Clinique De Nephrologie

    La Tronche, 38700

  • Agduc Muller

    La Tronche, 38701

  • Ch De Laon; Nephrologie Hemodialyse

    Laon, 02001

  • Hopital Prive De L Estuaire; Nephrologie Hemodialyse

    Le Havre, 76620

  • Ch Emile Roux; Nephrologie

    Le Puy-en-Velay, 43012

  • Hopital Claude Huriez; Nephrologie

    Lille, 59037

  • Polyclinique De La Louviere; Nephrologie

    Lille, 59042

  • Ctre Hosp St Joseph Et St Luc; Nephrologie Hemodialyse

    Lyon, 69365

  • Hopital Edouard-Herriot; Nephrologie - Hemodialyse

    Lyon, 69437

  • Clinique Bouchard ; Nephrologie

    Marseille, 13253

  • Hopital De La Conception; Hemodialyse

    Marseille, 13385

  • Hopital De La Conception; Nephrologie

    Marseille, 13385

  • Ch De Meaux; Medecine C

    Meaux, 77104

  • Hopital Layne; Nephrologie Hemodialyse

    Mont-de-Marsan, 40024

  • Hopital Hotel Dieu; Medecine Geriatrique Nephrologie

    Mont-Saint-Martin, 54350

  • Centre D Hemodialyse Sodetir

    Montereau, 77871

  • Centre Aider; Centre Aider Montpellier

    Montpellier, 34295

  • Centre De Dialyse La Fonderie

    Mullhouse, 68100

  • Polyclinique De Gentilly; Hemodialyse

    Nancy, 54100

  • Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique

    Nantes, 44035

  • Hopital Hotel Dieu Et Hme; Hemodialyse Chronique

    Nantes, 44093

  • Echo Nantes Confluent; Uad Montfort

    Nantes, 44202

  • Hopital Pasteur; Pavillon A Nephrologie

    Nice, 06002

  • Centre Gardialyse

    Nîmes, 30900

  • Ctre Dialyse De La Reine Blanche

    Orléans, 45000

  • Hopital de La Source; Service de Nephrologie & Hemodialyse

    Orléans, 45100

  • Hopital Saint Louis; Service de Nephrologie - Transplantation

    Paris, 75475

  • Ch Pitie Salpetriere; Nephrologie Hemodialyse

    Paris, 75651

  • Hopital Europeen Georges Pompidou; Service de Nephrologie

    Paris, 75908

  • Hopital Tenon; Nephrologie Dialyse

    Paris, 75970

  • Hopital Saint Jean; Nephrologie

    Perpignan, 66046

  • Centre Hemodialyse Saint Martin

    Pessac, 33608

  • Ch Lyon Sud; Nephrologie Sect Jules Courmont

    Pierre-Bénite, 69495

  • Chi Poissy Saint Germain En Laye; Hemodialyse

    Poissy, 78303

  • Chu La Miletrie;Nephrologie Transplantation

    Poitiers, 86021

  • Association Pour L'Aide Des Uremiques de Bretagne

    Quimper, 29000

  • Hopital Pontchaillou; Nephrologie

    Rennes, 35033

  • Clinique De L Europe; Hemodialyse

    Rouen, 76040

  • Chi Du Val D Ariege; Gastro Enterologie Nephrologie

    Saint-Jean-de-Verges, 09000

  • Centre D Hemodialyse

    Saint-Laurent-du-Var, 06700

  • Centre D'Hemodialyse Arnaud Tzanck; Service Nephrologie - Hemodialyse

    Saint-Laurent-du-Var, 06721

  • Institut Arnault Tzanck; Med 2

    Saint-Laurent-du-Var, 06721

  • Memorial France Etats Unis; Nephrologie

    Saint-Lô, 50009

  • Artic; Bureau

    Saint-Priest-en-Jarez, 42270

  • Hopital Nord; Hopital De Jour

    Saint-Priest-en-Jarez, 42277

  • HOPITAL NORD; NEPH Transplantation Reanimation

    Saint-Priest-en-Jarez, 42277

  • Nephrocare Tassin Charcot; Nephrologie

    Sainte-Foy-lès-Lyon, 69110

  • Hopital Sud ; Nephrologie Hemodialyse

    Salouël, 80480

  • Centre Hospitalier De Sens; Nephrologie-Dialyse

    Sens, 89100

  • Ch Gaston Ramon; Nephrologie

    Sens, 89100

  • Ch De Soissons; Medecine 5

    Soissons, 02209

  • Hopital Broussais; Medecine 4

    St-Malo, 35043

  • Hopital Civil; Nephrologie Clinique Medicale B

    Strasbourg, 67091

  • Nephrocare Ile de France; Suresnes

    Suresnes, 92150

  • Hopital Foch; Nephrologie Hemodialyse

    Suresnes, 92151

  • Hopital de La Gespe; Dept of Nephrology

    Tarbes, 65013

  • Hopitaux Du Leman Site Thonon;Nephrologie

    Thonon-les-Bains, 74203

  • Hopital Sainte Musse; Nephrologie

    Toulon, 83056

  • Hopital Rangueil; Nephrologie Hemodialyse

    Toulouse, 31059

  • Clinique de Tournan; Service de Nephrologie

    Tournan-en-Brie, 77220

  • Hopital Bretonneau; Nephrologie Transplantations

    Tours, 37044

  • Ch Bretagne Atlantique De Vannes; Nephrologie

    Vannes, 56017

  • Hopital Saint Nicolas; Medecine A

    Verdun, 55107

  • Cabinet Medical

    Villeurbanne, 69200

Other trials in France

About this study

Official title: A Non-interventional Study to Assess the Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Patients Not in Dialysis Treated With Mircera®

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.

Being tested
Methoxy Polyethylene Glycol-Epoetin Beta

What participants receive

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

  • Methoxy Polyethylene Glycol-Epoetin BetaDrug

    Also called Mircera

    Methoxy polyethylene glycol-epoetin beta will be administered at the discretion of treating physician. Study protocol does not specify any treatment regimen.

Study groups in NCT01756612
Study groupRoleWhat they receive
Chronic Kidney Disease ParticipantsParticipants 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.
Receives: Drug: Methoxy Polyethylene Glycol-Epoetin Beta

What is being measured

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

  1. 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

    Measured: Baseline, Month 9

Secondary outcomes (7)

  1. Hemoglobin Levels According to Liu Index and Resistance Factors

    Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9

  2. Average Dose of Mircera in Total Population

    Measured: Baseline up to 9 months

  3. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Total Population

    Measured: Baseline up to 9 months

  4. Average Dose of Mircera in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation

    Measured: Baseline up to 9 months

  5. 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

    Measured: Baseline up to 9 months

  6. Duration of Treatment With Mircera

    Measured: Baseline up to 9 months

  7. Number of Participants Who Received Concomitant Treatment (Known as Potentially Resistant Factors) for Renal Anemia

    Measured: Baseline up to 9 month

Timeline

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

  1. First posted27 Dec 2012 (estimated)
  2. Study start21 Nov 2012
  3. Primary completion25 Mar 2015
  4. Study completion25 Mar 2015

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
551 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01756612
Sponsor's protocol ID
ML28145
Status last verified
Jul 2019
First submitted
19 Dec 2012
Last updated
15 Jul 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Anemia of Chronic Kidney Disease, run by Hoffmann-La Roche at 108 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 4 inclusion and 2 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 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 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?

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 (time frame: Baseline, Month 9). 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 NCT01756612.

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 15 Jul 2019; AzTrials last refreshed its copy on 29 Oct 2026.

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