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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]

• Registration Number: NCT00576628
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Study Start: 2008-05
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2016-07-21
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-07
• Last Update Submitted: 2016-10-07
• Results First Posted: 2016-11-30
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• adult patients, >=18 years of age;
• chronic renal anemia, with no need for dialysis expected in next 3 months;
• adequate iron status.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C.E.R.A	methoxy polyethylene glycol-epoetin beta [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.

Primary Outcome Measures

Name	Time	Method
Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period	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 Outcome Measures

Name	Time	Method
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	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.
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 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.
The Number of Participants Who Required Dose Adjustments During the Dose Titration Period	From Week 0 to Week 28 (DTP)	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.
Time to Achievement of Response During the Efficacy Evaluation Period	From Week 29 to Week 36	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.
Number of Participants With Red Blood Cells Transfusions.	Up to Week 52	The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported.
Mean Values of Laboratory Parameter : Hb Concentration	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48	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.
Mean Values of Laboratory Parameter : Hematocrit	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48	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.
Mean Values of Laboratory Parameter : Serum Creatinine	Baseline (Week 0), and Week 32	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.
Mean Values of Laboratory Parameter: C Reactive Protein	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48	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.
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	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.
Mean Values of Laboratory Parameter: Ferritin Concentration	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48	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.
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	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.
Mean Values of Laboratory Parameters: Transferrin Saturation	Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48	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.
The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period	From Week 29 to Week 36 (EEP)	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.
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	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.
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	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.