A Single Arm Open Label Multicentre Study to Assess the Efficacy, Safety and Tolerability of Monthly Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anaemia in Pre-dialysis Patients, Not Currently Treated With ESA
Overview
- Phase
- Phase 3
- Intervention
- methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 133
- Primary Endpoint
- Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adult patients, \>=18 years of age;
- •chronic renal anemia, with no need for dialysis expected in next 3 months;
- •adequate iron status.
Exclusion Criteria
- •previous epoetin therapy within 12 weeks prior to treatment;
- •transfusion of red blood cells during 2 months prior to screening;
- •significant acute or chronic bleeding such as overt gastrointestinal bleeding;
- •hemolysis;
- •folic acid and vitamin B 12 deficiency.
Arms & Interventions
C.E.R.A
Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range.
Intervention: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
Outcomes
Primary Outcomes
Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period
Time Frame: Baseline (Week 0) and from Week 29 to Week 36
The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36.
Secondary Outcomes
- Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP(From Week 29 to Week 36)
- Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period(From Week 29 to Week 36)
- The Number of Participants Who Required Dose Adjustments During the Dose Titration Period(From Week 0 to Week 28 (DTP))
- Time to Achievement of Response During the Efficacy Evaluation Period(From Week 29 to Week 36)
- Number of Participants With Red Blood Cells Transfusions.(Up to Week 52)
- Mean Values of Laboratory Parameter : Hb Concentration(Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48)
- Mean Values of Laboratory Parameter : Hematocrit(Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48)
- Mean Values of Laboratory Parameter : Serum Creatinine(Baseline (Week 0), and Week 32)
- Mean Values of Laboratory Parameter: C Reactive Protein(Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48)
- Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration(Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48)
- Mean Values of Laboratory Parameter: Ferritin Concentration(Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48)
- Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count(Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48)
- Mean Values of Laboratory Parameters: Transferrin Saturation(Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48)
- The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period(From Week 29 to Week 36 (EEP))
- Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration(Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48)
- Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity(Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48)