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NCT01356589

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

Completed Results posted Last updated 5 July 2017
What this trial tests

trial in Anemia in 1,288 participants. Completed in 31 July 2012.

Timeline
30 September 2010
Primary endpoint
31 July 2012
31 July 2012

Quick facts

Lead sponsorHoffmann-La Roche
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,288
Start date30 September 2010
Primary completion31 July 2012
Estimated completion31 July 2012
Sites33 locations across Greece

Conditions studied

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Anemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With at Least One Hemoglobin Cycling Primary · 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.

GroupValue95% CI
Mircera31.84
Number of Full Hemoglobin Cycles Per Participant Secondary · 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.

GroupValue95% CI
Mircera0.38± 0.61
Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling Secondary · 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.

GroupValue95% CI
Mircera29.83

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Anemia

Currently open trials in the same condition.

Other Hoffmann-La Roche trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01356589.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing