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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
189
iv 0.6 micrograms/kg every 2 weeks
Unnamed facility
Ahmedabad, India
Unnamed facility
Bangalore, India
Unnamed facility
Chennai, India
Unnamed facility
Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period
The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.
Time frame: Baseline (Week 0) and Week 16
Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter
Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.
Time frame: Up to Week 16
Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented.
Time frame: Week 12 to Week 16
Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.
Time frame: Week 12 to Week 16
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above
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Coimbatore, India
Unnamed facility
Gujarat, India
Unnamed facility
Hyderabad, India
Unnamed facility
Kerala, India
Unnamed facility
Kolkata, India
Unnamed facility
Ludhiana, India
Unnamed facility
Mumbai, India
...and 6 more locations
Time frame: Up to Week 18
Number of Participants With Abnormal Electrocardiogram
Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.
Time frame: Up to Week 16
Number of Participants With Reports of Blood Transfusions
Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.
Time frame: Up to Week 16
Number of Participants With Reports of Anti-Epoetin Antibodies
Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.
Time frame: Up to Week 16
Mean White Blood Cell Count Over Time
The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Value of Mean Corpuscular Volume Over Time
Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Hypochromic Red Blood Cells Over Time
Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Platelet Count Over Time
Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Iron Over Time
Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Ferritin Over Time
Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Transferrin Over Time
Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Total Iron-binding Capacity Over Time
Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Transferrin Saturation Over Time
Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Albumin Over Time
Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Globulin Over Time
Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Creatinine Over Time
Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Blood Urea Nitrogen Over Time
Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Potassium Over Time
Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Sodium Over Time
Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Phosphate Over Time
Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Bilirubin Over Time
Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Aspartate Transaminase Over Time
Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Alanine Aminotransferase Over Time
Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Alkaline Phosphatase Over Time
Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16