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A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01356589
First Posted: May 19, 2011
Last Update Posted: July 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a 9-month treatment period.

Condition
Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study on Intrapatient VAriabiLity of the Hemoglobin Levels in Anemic CKD Patients in Predialysis (Stage 3-4) and Dialysis (Stage 5) Treated With MIRCERA® (RIVAL Study)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With at Least One Hemoglobin Cycling [ Time Frame: 9 months ]
    Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (>=) 1.5 gram per deciliter (g/dL) and a duration >=8 weeks.


Secondary Outcome Measures:
  • Number of Full Hemoglobin Cycles Per Participant [ Time Frame: 9 months ]
    Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.

  • Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling [ Time Frame: 9 months ]
    Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.


Enrollment: 1288
Actual Study Start Date: September 30, 2010
Study Completion Date: July 31, 2012
Primary Completion Date: July 31, 2012 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic kidney disease patients with anemia treated with Mircera
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic kidney disease in predialysis (stage 3 and 4) and dialysis
  • Renal anemia treated with Mircera according to label for at least 9 months before date of signed informed consent

Exclusion Criteria:

  • Participation in an interventional clinical trial within the retrospective observation period
  • Contraindications to Mircera administration as per label or judged by the investigator
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356589


Locations
Greece
General Hospital of Artas; Nephrology
Arta, Greece, 47100
Attikon Center; Nephrology
Athens, Greece, 11362
Athinaiki Private Clinic
Athens, Greece, 11521
Hospital henry dunant; Nephrology
Athens, Greece, 11526
General Hospital Hippokration of Athens; Nephrology
Athens, Greece, 11527
General Hospital Of Athens G.Gennimatas; Nephrology
Athens, Greece, 11527
Kyanos Stavros Private Hospital; Nephrologic Clinic
Athens, Greece, 11528
General Hospital Of West Attikis; Nephrology
Athens, Greece, 12351
University Hospital Attikon ; Pathology Clinic
Athens, Greece, 124 61
Iaso General Private Clinic; Nephrology
Athens, Greece, 15562
General Hospital Agia Olga; Nephrology
Athen, Greece, 14233
Iatriko Athinon Clinic Dafnis; Nephrology Department
Daphni-athens, Greece, 17237
General Hospital Of Dramas; Dialysis Center Unit
Drama, Greece, 66100
Timios Stavros Clinic; Nephrology Department
Egaleo, Greece, 12244
University Hospital Of Heraklion; Nefrologiki Clinic
Heraklion, Greece, 71110
General Hospital Of Katerinis; Nephrology Unit
Katerini, Greece
General Hospital Of Lamias; Nephrology
Lamia, Greece, 35100
Univeristy Hospital of Larissa; Nephrology
Larissa, Greece, 41 110
Eytychios Patsidis Center Of Haemodialysis
Larissa, Greece, 41335
Leivadia General Hospital; Nephrologic Clinic
Leivadia, Greece, 32100
General Hospital Of Leykadas; Dialysis Center Unit
Leykada, Greece, 31100
Kyanous Stavros of Patras, Renal Disease Therapy Unit
Patra, Greece, 26225
Olympion Therapeytirion; Nefrology
Patra, Greece, 26443
General Hospital Tzanio ; Nephrology
Piraeus, Greece, 18536
General Hospital Of Chalkidikis; Dialysis Center Unit
Polygyros, Greece, 63100
Rodos General Hospital; Nephrologic Clinic
Rhodes, Greece, 85100
Alpha Nephrodynamiki Of Serres; Dialysis Center Unit
Serres, Greece
Ahepa Hospital; 1St Dept. of Medicine
Thessaloniki, Greece, 54636
IPPOKRATES Private Dialysis Centre
Thessaloniki, Greece, 54643
General Hospital Of Thessalonikis Papageorgiou; Nephrology
Thessaloniki, Greece, 56403
Alfa Nefrodynamiki; Nefrology
Thessaloniki, Greece, 57500
Thessaliki Nossileytiki; Nephrology
Volos, Greece, 38221
General Hospital of Volos; Nephrology
Volos, Greece, 38222
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01356589     History of Changes
Other Study ID Numbers: ML25289
First Submitted: May 18, 2011
First Posted: May 19, 2011
Results First Submitted: November 23, 2015
Results First Posted: December 28, 2015
Last Update Posted: July 5, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Anemia
Hematologic Diseases