A Single Arm, Open Label, Multicenter Phase IIIb/IV Clinical Trial to Assess the Efficacy, Safety and Tolerability of Monthly Administration of C.E.R.A. for the Treatment of Not on Dialysis Chronic Renal Anemia Not Currently Treated With ESA
Overview
- Phase
- Phase 4
- Intervention
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 70
- Locations
- 5
- Primary Endpoint
- Change From Baseline in Mean Hb Concentration at Week 20
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients, age \>/=18 years
- •Diagnosis of chronic renal anemia
- •Not on dialysis
- •Hemoglobin concentration \<10 g/dl
- •No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start
- •Estimated glomerular filtration rate (EGFR) \<60 ml/min and \>/=20 ml/min
- •Adequate iron status
Exclusion Criteria
- •Transfusion of red blood cells during the previous 2 months
- •Poorly controlled hypertension
- •Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
- •Active malignant disease (except non-melanoma skin cancer)
- •Hemolysis
- •Hemoglobinopathies, e.g. sickle-cell disease, thalassemia
Arms & Interventions
Single Arm
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Outcomes
Primary Outcomes
Change From Baseline in Mean Hb Concentration at Week 20
Time Frame: Baseline (Week 0), Week 20
Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to \[≤\] 100 nanogram per milliliter \[ng/mL\] or mean transferrin saturation \[TSAT\] ≤20% or mean hypochromic red blood cells \[RBCs\] greater than or equal to \[≥\] 10% during efficacy evaluation period \[Weeks 20 to 28\]).
Change From Baseline in Mean Hb Concentration at Week 24
Time Frame: Baseline (Week 0), Week 24
PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period \[Weeks 20 to 28\]).
Change From Baseline in Mean Hb Concentration at Week 28
Time Frame: Baseline (Week 0), Week 28
PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period \[Weeks 20 to 28\]).