Phase 3
N=125
A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00576628 ↗Enrolled (actual)
125
Serious AEs
24.8%
Results posted
Nov 2016
Primary outcome: Primary: Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period — 1.75 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- methoxy polyethylene glycol-epoetin beta [C.E.R.A.] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period |
1.75 | — |
| SECONDARY Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP |
66.7 | — |
| SECONDARY Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period |
37.4 | — |
| SECONDARY The Number of Participants Who Required Dose Adjustments During the Dose Titration Period |
61 | — |
| SECONDARY Time to Achievement of Response During the Efficacy Evaluation Period |
30.8 | — |
| SECONDARY Number of Participants With Red Blood Cells Transfusions. |
1 | — |
| SECONDARY Mean Values of Laboratory Parameter : Hb Concentration |
10.0; 11.7; 12.2; 11.6; 12.0; 11.8 | — |
| SECONDARY Mean Values of Laboratory Parameter : Hematocrit |
0.30; 0.34; 0.36; 0.34; 0.35; 0.35 | — |
| SECONDARY Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration |
1.5; 1.6; 1.5; 1.6; 1.6; 1.6 | — |
| SECONDARY Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity |
16.0; 14.0; 14.9; 15.9; 16.6; 15.7 | — |
| SECONDARY Mean Values of Laboratory Parameter : Serum Creatinine |
317.8; 361.3 | — |
| SECONDARY Mean Values of Laboratory Parameter: C Reactive Protein |
4.1; 6.0; 6.5; 6.2; 4.5; 3.8 | — |
| SECONDARY Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration |
41.0; 40.5; 41.5; 40.9; 42.4; 41.3 | — |
| SECONDARY Mean Values of Laboratory Parameter: Ferritin Concentration |
231.6; 152.4; 149.3; 154.1; 171.8; 179.6 | — |
| SECONDARY Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count |
7.1; 7.2; 7.1; 7.1; 7.2; 6.9 | — |
| SECONDARY Mean Values of Laboratory Parameters: Transferrin Saturation |
32.1; 25.7; 27.8; 30.1; 32.1; 30.0 | — |
| SECONDARY The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period |
34 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00576628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.