A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
- Conditions
- Anemia
- Interventions
- Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
- Registration Number
- NCT00737464
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
- 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.
- blood transfusion within the previous 2 months;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease;
- congestive heart failure (NYHA Class IV).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mircera methoxy polyethylene glycol-epoetin beta [Mircera] Participant with chronic renal anemia will receive methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12) Weeks 8 to 12 (Last 4 weeks of treatment period) 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.
- Secondary Outcome Measures
Name Time Method Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time At Weeks -2, 4, 8, and 12 Mean values of serum iron and total iron binding capacity (TIBC) were reported.
Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12) SVP (Weeks -2 to -1) and TP (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.
Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL Up to Week 12 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.
Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths Up to Week 14 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.
Mean Change From Baseline in Heart Rate Over Time From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12 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.
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12 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.
Number of Participants With Abnormal Electrocardiogram At Week -2 and Week 12 Participants with abnormal electrocardiogram were reported.
Mean Values of Serum Albumin and Serum Globulin Over Time At Weeks -2, 4, 8, and 12 Mean values of serum albumin and serum globulin were reported.
Mean Values of White Blood Cells and Platelets Over Time At Weeks -2, 4, 8, and 12 Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.
Mean Corpuscular Volume Levels Over Time At Weeks -2, 4, 8, and 12 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.
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time At Weeks -2, 4, 8, and 12 Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.
Mean Values of Serum Sodium and Serum Potassium Over Time At Weeks -2, 4, 8, and 12 Mean values of serum sodium and serum potassium were reported.
Mean Values of Hypochromic Red Blood Cells Over Time At Weeks -2, 4, 8, and 12 Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.
Mean Values of Serum Ferritin Over Time At Weeks -2, 4, 8, and 12 Mean values of serum ferritin were reported.
Mean Values of Transferrin Over Time At Weeks -2, 4, 8, and 12 Mean values of transferrin were reported.
Mean Values of Transferrin Saturation Over Time At Weeks -2, 4, 8, and 12 Mean values of Transferrin Saturation (TSAT) were reported.
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time At Weeks -2, 4, 8, and 12 Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.
Trial Locations
- Locations (17)
Nizam's Institute of Medical Sciences; Nephrology
🇮🇳Hyderabad, India
Wockhardt Hospital and Kidney Institute; Nephrology
🇮🇳Kolkata, India
Meerut Kidney Hospital
🇮🇳Meerut, India
Manipal Institute of Nephrology and Urology; Nephrology
🇮🇳Bangalore, India
MIOT Institute of Nephrology ; Nephrology
🇮🇳Chennai, India
Madras Medical Mission Hospital
🇮🇳Chennai, India
Kamineni Hospitals; Nephrology
🇮🇳Hyderabad, India
Indraprastha Apollo Hospitals
🇮🇳New Delhi, Delhi, India
Tanker Foundation
🇮🇳Chennai, India
International Hospital
🇮🇳Guwahati, India
Silver Oaks Hospital; Nephrology
🇮🇳Mohali, India
Lancelot Dialysis Center
🇮🇳Mumbai, India
Apex Kidney Care
🇮🇳Mumbai, India
Columbia Asia Medical Centre - Hebbal; Nephrology
🇮🇳Bangalore, India
Regency Hospital Ltd.; Nephrology
🇮🇳Kanpur, India
Fortis Flt. Lt. Rajan Dhall Hospital; Nephrology
🇮🇳New Delhi, India
Ruby Hall Clinic
🇮🇳Pune, India