Phase 4
Completed N=189
A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.
Source: ClinicalTrials.gov NCT00737711 ↗Enrolled (actual)
189
Serious AEs
12.7%
Results posted
Jun 2016
Primary outcomePrimary: Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period — 2.11 gram/deciliter (g/dL) — p=<0.0001
Summary
This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period |
2.11 | <0.0001 sig |
| SECONDARY Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter |
6.10 | — |
| SECONDARY Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16 |
3.07 | — |
| SECONDARY Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16 |
46.20 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events and Deaths |
53; 24; 8 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiogram |
52; 49 | — |
| SECONDARY Number of Participants With Reports of Blood Transfusions |
1; 6; 0 | — |
| SECONDARY Number of Participants With Reports of Anti-Epoetin Antibodies |
— | — |
| SECONDARY Mean White Blood Cell Count Over Time |
9382.89; 9181.27; 9361.38; 9023.71 | — |
| SECONDARY Mean Value of Mean Corpuscular Volume Over Time |
87.05; 89.17; 88.46; 88.03 | — |
| SECONDARY Mean Hypochromic Red Blood Cells Over Time |
3.84; 2.74; 3.23; 3.52 | — |
| SECONDARY Mean Platelet Count Over Time |
214629.03; 203050.85; 204922.16; 194550.63 | — |
| SECONDARY Mean Serum Iron Over Time |
91.72; 80.17; 87.62; 91.70 | — |
| SECONDARY Mean Serum Ferritin Over Time |
963.28; 702.37; 686.42; 641.26 | — |
| SECONDARY Mean Transferrin Over Time |
173.48; 176.97; 237.98; 181.50 | — |
| SECONDARY Mean Total Iron-binding Capacity Over Time |
247.06; 243.25; 245.30; 245.30 | — |
| SECONDARY Mean Transferrin Saturation Over Time |
40.39; 35.31; 36.91; 38.31 | — |
| SECONDARY Mean Serum Albumin Over Time |
3.51; 3.48; 3.57; 3.61 | — |
| SECONDARY Mean Serum Globulin Over Time |
3.36; 3.24; 3.33; 3.50 | — |
| SECONDARY Mean Serum Creatinine Over Time |
8.25; 8.65; 9.48; 9.05 | — |
| SECONDARY Mean Blood Urea Nitrogen Over Time |
68.98; 66.19; 67.21; 69.88 | — |
| SECONDARY Mean Serum Potassium Over Time |
5.76; 5.23; 7.53; 8.30 | — |
| SECONDARY Mean Serum Sodium Over Time |
136.4; 136.3; 133.9; 137.0 | — |
| SECONDARY Mean Serum Phosphate Over Time |
6.20; 6.32; 8.71; 6.17 | — |
| SECONDARY Mean Serum Bilirubin Over Time |
0.58; 0.68; 0.70; 0.62 | — |
| SECONDARY Mean Aspartate Transaminase Over Time |
22.33; 21.69; 24.61; 22.63 | — |
| SECONDARY Mean Alanine Aminotransferase Over Time |
27.89; 26.80; 28.11; 29.21 | — |
| SECONDARY Mean Serum Alkaline Phosphatase Over Time |
176.2; 161.7; 161.7; 153.5 | — |
Eligibility Criteria
Inclusion Criteria
- male or female patients, >=18 years of age;
- chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
- no prior erythropoietin stimulating agent (ESA) therapy.
Exclusion Criteria
- blood transfusion within the previous 4 weeks;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease;
- congestive heart failure (NYHA Class IV).
Data sourced from ClinicalTrials.gov (NCT00737711). 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.