Phase 2
Completed N=137
A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.
Source: ClinicalTrials.gov NCT00364832 ↗Enrolled (actual)
137
Serious AEs
35.0%
Results posted
Dec 2016
Primary outcomePrimary: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen — -0.80; -0.60; -0.29; 0.02 gram per deciliter
Summary
This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen |
-0.80; -0.60; -0.29; 0.02; -0.14; -0.28 | — |
| SECONDARY Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen |
-2.45; -1.95; -0.93; 0.25; -0.37; -0.75 | — |
| SECONDARY Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis |
-1; 7; 2; -8; -4; -6 | — |
| SECONDARY Mean Change in Pulse Rate |
-6; -2; 7; -1; -1; 2 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths |
44; 33; 40; 15; 13; 20 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- chronic renal anemia;
- on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
- receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period.
Exclusion Criteria
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- use of any investigational drug within 30 days preceding the run-in phase, or during the run-in or study treatment period.
Data sourced from ClinicalTrials.gov (NCT00364832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.