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

NCT01356589 | Completed Results

• 1 other identifier: ML25289
• Study Type: observational
• Target: 1,288
• Locations: 1 country
• Sites: 33

Brief Summary

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least One Hemoglobin Cycling

  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.

  9 months

Secondary Outcomes (2)

• Number of Full Hemoglobin Cycles Per Participant

  9 months

• Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling

  9 months

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic kidney disease patients with anemia treated with Mircera

You may qualify if:

• 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

You may not qualify if:

• Participation in an interventional clinical trial within the retrospective observation period
• Contraindications to Mircera administration as per label or judged by the investigator

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (33)

Timios Stavros Clinic; Nephrology Department

Aigáleo, 12244, Greece

Location

General Hospital of Artas; Nephrology

Arta, 47100, Greece

Location

Attikon Center; Nephrology

Athens, 11362, Greece

Location

Athinaiki Private Clinic

Athens, 11521, Greece

Location

Hospital henry dunant; Nephrology

Athens, 11526, Greece

Location

General Hospital Hippokration of Athens; Nephrology

Athens, 11527, Greece

Location

General Hospital Of Athens G.Gennimatas; Nephrology

Athens, 11527, Greece

Location

Kyanos Stavros Private Hospital; Nephrologic Clinic

Athens, 11528, Greece

Location

General Hospital Of West Attikis; Nephrology

Athens, 12351, Greece

Location

University Hospital Attikon ; Pathology Clinic

Athens, 124 61, Greece

Location

General Hospital Agia Olga; Nephrology

Athens, 14233, Greece

Location

Iaso General Private Clinic; Nephrology

Athens, 15562, Greece

Location

Iatriko Athinon Clinic Dafnis; Nephrology Department

Daphni-athens, 17237, Greece

Location

General Hospital Of Dramas; Dialysis Center Unit

Drama, 66100, Greece

Location

University Hospital Of Heraklion; Nefrologiki Clinic

Heraklion, 71110, Greece

Location

General Hospital Of Katerinis; Nephrology Unit

Katerini, Greece

Location

General Hospital Of Lamias; Nephrology

Lamia, 35100, Greece

Location

Univeristy Hospital of Larissa; Nephrology

Larissa, 41 110, Greece

Location

Eytychios Patsidis Center Of Haemodialysis

Larissa, 41335, Greece

Location

General Hospital Of Leykadas; Dialysis Center Unit

Leykada, 31100, Greece

Location

Leivadia General Hospital; Nephrologic Clinic

Livadeia, 32100, Greece

Location

Kyanous Stavros of Patras, Renal Disease Therapy Unit

Pátrai, 26225, Greece

Location

Olympion Therapeytirion; Nefrology

Pátrai, 26443, Greece

Location

General Hospital Tzanio ; Nephrology

Piraeus, 18536, Greece

Location

General Hospital Of Chalkidikis; Dialysis Center Unit

Polygyros, 63100, Greece

Location

Rodos General Hospital; Nephrologic Clinic

Rhodes, 85100, Greece

Location

Alpha Nephrodynamiki Of Serres; Dialysis Center Unit

Serres, Greece

Location

Ahepa Hospital; 1St Dept. of Medicine

Thessaloniki, 54636, Greece

Location

IPPOKRATES Private Dialysis Centre

Thessaloniki, 54643, Greece

Location

General Hospital Of Thessalonikis Papageorgiou; Nephrology

Thessaloniki, 56403, Greece

Location

Alfa Nefrodynamiki; Nefrology

Thessaloniki, 57500, Greece

Location

Thessaliki Nossileytiki; Nephrology

Volos, 38221, Greece

Location

General Hospital of Volos; Nephrology

Volos, 38222, Greece

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 19, 2011
• Study Start: September 30, 2010
• Primary Completion: July 31, 2012
• Study Completion: July 31, 2012
• Last Updated: July 5, 2017
• Results First Posted: December 28, 2015

Record last verified: 2017-05

Locations

GR (33)