A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia
- Conditions
- Anemia
- Interventions
- Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
- Registration Number
- NCT00882713
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
- adult patients >=18 years of age;
- chronic renal anemia;
- regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;
- continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease (except non-melanoma skin cancer).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description C.E.R.A. methoxy polyethylene glycol-epoetin beta [Mircera] Eligible participants will be administered continuous erythropoietin receptor activator (C.E.R.A.\[Mircera\]) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of 120, 200, or 360 micrograms (mcg) will be based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin (Hb) within a range of +/- 1.0 grams per deciliter (g/dL) of the reference hemoglobin (Hb) concentration and between 10.50 and 12.50 g/dL.
- Primary Outcome Measures
Name Time Method Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period EEP (Week 17 to Week 24) The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.
- Secondary Outcome Measures
Name Time Method Number of Participants With Any Adverse Events or Serious Adverse Events Up to Week 52 An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly.
Mean Hematocrit Levels Over Time Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Mean Albumin Levels Over Time Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Mean Change From Baseline in Weight Over Time Week 16 and Week 48 Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48).
Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either \> or = 13 g/dL or \< or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was \> or =2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was \>1 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.
Mean Hemoglobin Levels Over Time Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24) Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP.
Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP EEP (Week 17 to Week 24) Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24.
Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase Up to Week 52 Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported.
Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP EEP (Week 17 to Week 24) Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24.
Mean Phosphate and Potassium Levels Over Time Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Mean White Blood Cells and Thrombocytes Over Time Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Mean C-Reactive Protein Levels Over Time Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Mean Ferritin Levels Over Time Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Mean Transferrin Saturation Levels Over Time Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Mean Change From Baseline in Pulse Rate Over Time Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).
Mean Change From Baseline in Blood Pressure Over Time Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48 Mean change in blood pressure (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).