Phase 4
N=132
A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00737464 ↗Enrolled (actual)
132
Serious AEs
6.8%
Results posted
Apr 2016
Primary outcome: Primary: Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12) — 57.89 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12) |
57.89 | — |
| SECONDARY Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12) |
10.76; 11.28 | — |
| SECONDARY Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL |
3.15 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths |
27; 9; 3 | — |
| SECONDARY Mean Change From Baseline in Heart Rate Over Time |
78.79; 79.54; 78.64; 78.98; 78.61; 79.55 | — |
| SECONDARY Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time |
145.04; 145.51; 146.72; 143.26; 145.05; 143.75 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiogram |
61; 50 | — |
| SECONDARY Mean Values of White Blood Cells and Platelets Over Time |
7527.50; 7369.74; 7506.61; 7484.35; 211772.73; 199508.77 | — |
| SECONDARY Mean Values of Hypochromic Red Blood Cells Over Time |
3.58; 3.73; 3.88; 3.97 | — |
| SECONDARY Mean Corpuscular Volume Levels Over Time |
90.32; 89.99; 89.41; 88.09 | — |
| SECONDARY Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time |
102.13; 108.56; 116.79; 110.53; 273.44; 266.98 | — |
| SECONDARY Mean Values of Serum Ferritin Over Time |
1806.30; 1422.48; 1109.07; 1109.80 | — |
| SECONDARY Mean Values of Transferrin Over Time |
168.24; 160.00; 165.72; 159.22 | — |
| SECONDARY Mean Values of Transferrin Saturation Over Time |
45.55; 48.70; 46.08; 45.71 | — |
| SECONDARY Mean Values of Serum Albumin and Serum Globulin Over Time |
3.60; 3.54; 3.58; 3.64; 3.48; 3.41 | — |
| SECONDARY Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time |
23.48; 23.26; 22.86; 23.17; 31.34; 30.18 | — |
| SECONDARY Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time |
7.89; 8.34; 8.03; 8.19; 57.72; 60.67 | — |
| SECONDARY Mean Values of Serum Sodium and Serum Potassium Over Time |
5.00; 6.26; 5.11; 5.03; 137.1; 136.2 | — |
Summary
This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- male or female patients, >=18 years of age;
- chronic renal anemia;
- Hb concentration 10.5g/dL - 12.5g/dL;
- continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.
Exclusion Criteria
- blood transfusion within the previous 2 months;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease;
- congestive heart failure (NYHA Class IV).
Data sourced from ClinicalTrials.gov (NCT00737464). 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.