Phase 3
N=233
A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00560404 ↗Enrolled (actual)
233
Serious AEs
18.5%
Results posted
Apr 2016
Primary outcome: Primary: Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period — 50.7; 53.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- methoxy polyethylene glycol-epoetin beta [Mircera] (Drug); Epoetin alfa (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period |
50.7; 53.0 | — |
| SECONDARY Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period |
-0.02; 0.05 | — |
| SECONDARY Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period |
30.9; 39.4 | — |
| SECONDARY Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period |
30.4; 33.9 | — |
| SECONDARY Number of Participants Who Required Dose Adjustments During the Dose Titration Period |
88; 98 | — |
| SECONDARY Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period |
35; 39 | — |
| SECONDARY Number of Participants Received Red Blood Cells Transfusions |
8; 3 | — |
| SECONDARY Mean Values of Hemoglobin Concentration at Baseline and Week 36 |
11.6; 11.6; 11.5; 11.7 | — |
| SECONDARY Mean Values of Hematocrit at Baseline and Week 36 |
0.35; 0.35; 0.35; 0.36 | — |
| SECONDARY Mean Values of Mean Corpuscular Volume at Baseline and Week 36 |
91.9; 92.2; 90.6; 91.6 | — |
| SECONDARY Mean Values of Leukocytes and Platelets Count at Baseline and Week 36 |
6.8; 6.6; 6.5; 6.5; 194.8; 204.4 | — |
| SECONDARY Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36 |
850.4; 916.6; 881.0; 876.1; 5.2; 5.2 | — |
| SECONDARY Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36 |
39.2; 39.9; 39.3; 39.8; 1.65; 1.77 | — |
| SECONDARY Mean Values of Ferritin Concentration at Baseline and Week 36 |
777.8; 621.4; 736.9; 609.9 | — |
| SECONDARY Mean Values of Transferrin Saturation at Baseline and Week 36 |
38.0; 36.2; 44.4; 31.7 | — |
| SECONDARY Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36 |
16.4; 16.6; 17.2; 17.1; 106.4; 118.0 | — |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events |
99; 106; 27; 16 | — |
| SECONDARY Number of Participants With Abnormal Changes in ECG From Baseline to Week 40 |
0; 0 | — |
| SECONDARY Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40 |
0; 0 | — |
Summary
This 2 arm study will compare the efficacy and safety of monthly administration of subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized to receive either monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- chronic renal anemia;
- regular hemodialysis with the same schedule of dialysis for >=12 weeks;
- maintenance therapy with subcutaneous epoetin alfa at the same administration interval for 4 weeks.
Exclusion Criteria
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring interruption of epoetin alfa in previous 6 months;
- acute or chronic bleeding;
- active malignant disease (except non-melanoma skin cancer).
Data sourced from ClinicalTrials.gov (NCT00560404). 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.