A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anemia

Intervention / Treatment
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* Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C.E.R.A<br>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. | Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]<br>* Recommended starting dose 1.2 micrograms/kg sc monthly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period | 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. | Baseline (Week 0) and from Week 29 to Week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP | Percentage of participants maintaining individual Hb concentration within the range of 11.0-13.0 g/dL was reported during EEP. The EEP was from Week 29 to Week 36. | 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 | The number of days spent by participants with Hb in range of 11.30 -13.0 g/dL was calculated during the EEP and presented. The EEP comprised was from Week 29 to Week 36. | From Week 29 to Week 36 | 
| The Number of Participants Who Required Dose Adjustments During the Dose Titration Period | The number of participants who required dose adjustments of C.E.R.A was reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28. | From Week 0 to Week 28 (DTP) | 
| Time to Achievement of Response During the Efficacy Evaluation Period | The time to achievement of response was defined as the time when the participants achieved Hb concentration within the target range of 11.0 to 13.0 g/dL during the EEP. The EEP was from Week 29 to Week 36. | From Week 29 to Week 36 | 
| Number of Participants With Red Blood Cells Transfusions. | The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. | Up to Week 52 | 
| Mean Values of Laboratory Parameter : Hb Concentration | The mean Hb concentration for each individual participant throughout the study was estimated. Summary data of mean values of Hb concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | 
| Mean Values of Laboratory Parameter : Hematocrit | Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. The mean values of hematocrit for each individual participant were estimated throughout the study. Summary data of mean values of hematocrit at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | 
| Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | The mean values of potassium and phosphate levels in serum for each individual participant were estimated throughout the study. Summary data of mean values of potassium and phosphate level in serum at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | 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 | The mean values of iron and total iron binding capacity (TIBC) for each individual participant were estimated throughout the study. Summary data of mean values of iron and TIBC at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | 
| Mean Values of Laboratory Parameter : Serum Creatinine | The mean values of serum creatinine for each individual participant throughout the study were estimated. Summary data of mean values of serum creatinine at Week 0 (Baseline) and Week 32 are presented. | Baseline (Week 0), and Week 32 | 
| Mean Values of Laboratory Parameter: C Reactive Protein | The mean values of C reactive protein (CRP) for each individual participant throughout the study were estimated. Summary data of mean values of CRP at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | 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 | The mean values of albumin and transferrin concentration for each individual participant throughout the study were estimated. Summary data of mean values of albumin and transferrin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | 
| Mean Values of Laboratory Parameter: Ferritin Concentration | The mean values of ferritin concentration for each individual participant throughout the study were estimated. Summary data of mean values of ferritin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | 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 | The mean values of white blood cell (WBC) and thrombocyte count for each individual participant were estimated throughout the study. Summary data of mean values of WBC and thrombocyte count at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | 
| Mean Values of Laboratory Parameters: Transferrin Saturation | The mean values for transferrin saturation (TSAT) for each individual participant were estimated throughout the study. Summary data of mean values of TSAT at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | 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 | The number of participants who required dose adjustments of C.E.R.A was reported during the EEP. EEP was from Week 29 to Week 36. | From Week 29 to Week 36 (EEP) |