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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, India
Manipal Institute of Nephrology and Urology; Nephrology
Bangalore, India
Columbia Asia Medical Centre - Hebbal; Nephrology
Bangalore, India
Tanker Foundation
Chennai, India
MIOT Institute of Nephrology ; Nephrology
Chennai, India
Madras Medical Mission Hospital
Chennai, India
International Hospital
Guwahati, India
Kamineni Hospitals; Nephrology
Hyderabad, India
Nizam's Institute of Medical Sciences; Nephrology
Hyderabad, India
Regency Hospital Ltd.; Nephrology
Kanpur, India
...and 7 more locations
Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)
Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not \>12.0 g/dL and not \<10.0 g/dL.
Time frame: Weeks 8 to 12 (Last 4 weeks of treatment period)
Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)
The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not \>12.0 g/dL and not \<10.0 g/dL.
Time frame: SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)
Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL
Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not \>12.0 g/dL and not \<10.0 g/dL.
Time frame: Up to Week 12
Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths
Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to Week 14
Mean Change From Baseline in Heart Rate Over Time
Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter.
Time frame: From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter.
Time frame: From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12
Number of Participants With Abnormal Electrocardiogram
Participants with abnormal electrocardiogram were reported.
Time frame: At Week -2 and Week 12
Mean Values of White Blood Cells and Platelets Over Time
Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Hypochromic Red Blood Cells Over Time
Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.
Time frame: At Weeks -2, 4, 8, and 12
Mean Corpuscular Volume Levels Over Time
Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported.
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
Mean values of serum iron and total iron binding capacity (TIBC) were reported.
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Serum Ferritin Over Time
Mean values of serum ferritin were reported.
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Transferrin Over Time
Mean values of transferrin were reported.
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Transferrin Saturation Over Time
Mean values of Transferrin Saturation (TSAT) were reported.
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Serum Albumin and Serum Globulin Over Time
Mean values of serum albumin and serum globulin were reported.
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Serum Sodium and Serum Potassium Over Time
Mean values of serum sodium and serum potassium were reported.
Time frame: At Weeks -2, 4, 8, and 12
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