A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis
- Conditions
- Anemia
- Interventions
- Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
- Registration Number
- NCT00922116
- 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 patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. 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
- 191
- adult patients, >=18 years of age;
- chronic renal anemia;
- continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.
- 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 1 methoxy polyethylene glycol-epoetin beta [Mircera] -
- Primary Outcome Measures
Name Time Method Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP) EEP (Weeks 17 to 24) The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period \[SVP\]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.
- Secondary Outcome Measures
Name Time Method Average Dose of Mircera Per Month Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24 Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP EEP (Weeks 17 to 24) EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.
Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP Weeks 1 to 24 DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP Weeks 1 to 24 DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Change in Hemoglobin Concentration Between SVP and the EEP SVP (Baseline), and EEP (Weeks 17 to 24) Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.
Trial Locations
- Locations (10)
Kyungpook National Uni Hospital; Internal Medicine
🇰🇷Daegu, Korea, Republic of
Inje University Busan Paik Hospital; Nephrology
🇰🇷Busan, Korea, Republic of
Chungnam National Uni Hospital; Nephrology
🇰🇷Daejeon, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
NHIC Ilsan Hospital
🇰🇷Kyonggi-do, Korea, Republic of
Severance Hospital; Division of Nephrology
🇰🇷Seoul, Korea, Republic of
Seoul St Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National Uni Hospital; Internal Medicine
🇰🇷Seoul, Korea, Republic of
Samsung Medical Centre; Department of Hematology & Oncology
🇰🇷Seoul, Korea, Republic of
East-West Neo Medical Center; Division Of Nephology
🇰🇷Seoul, Korea, Republic of