Trial Outcomes & Findings for A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL) (NCT NCT01356589)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1288 participants

Primary outcome timeframe

9 months

Results posted on

2017-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	Mircera Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files.
Overall Study STARTED	1288
Overall Study Treated	1285
Overall Study COMPLETED	1283
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Mircera Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files.
Overall Study Enrolled, but not treated	3
Overall Study Dose data not recorded	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mircera n=1285 Participants Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files.
Age, Continuous	70.13 years STANDARD_DEVIATION 13.75 • n=93 Participants
Sex: Female, Male Female	570 Participants n=93 Participants
Sex: Female, Male Male	715 Participants n=93 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Analysis population included all treated participants.

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.

Outcome measures

Outcome measures
Measure	Mircera n=1285 Participants Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files.
Percentage of Participants With at Least One Hemoglobin Cycling	31.84 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: Analysis population included all treated participants.

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.

Outcome measures

Outcome measures
Measure	Mircera n=1285 Participants Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files.
Number of Full Hemoglobin Cycles Per Participant	0.38 cycles Standard Deviation 0.61

SECONDARY outcome

Timeframe: 9 months

Population: Analysis population included all treated participants. 'N' (number of participants analyzed) included those participants who were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Mircera n=207 Participants Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files.
Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling	29.83 percentage of participants

Adverse Events

Mircera

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER