C.E.R.A. Administered Up To Once Every Four Weeks Maintained Stable Hemoglobin Levels In Dialysis Patients With Chronic Kidney Disease
The C.E.R.A. trials represent a milestone in anemia management, as this is the first time an anti-anemia therapy has been studied in dosing intervals of up to once every four weeks for its initial Food and Drug Administration (FDA) filing.
"Maintaining hemoglobin levels within target range is important for the physical well being of the patient," said Nathan Levin, M.D., Medical and Research Director of the Renal Research Institute, New York and one of the lead investigators. "Furthermore, these new data showing that factors such as age, gender and diabetic status of the patient do not diminish the impact of C.E.R.A., are important, but not unexpected information."
About PROTOS and MAXIMA Phase III Maintenance Studies
The primary objective of the multi-center, phase III maintenance studies, PROTOS (Patients Receiving C.E.R.A. Once a Month for the MainTenance Of Stable Hemoglobin) and MAXIMA (Maintenance of HAemoglobin EXcels with IV Administration of C.E.R.A.), was to demonstrate that subcutaneous (SC) and intravenous (IV) C.E.R.A. can maintain Hb concentration in dialysis patients previously maintained on epoetin alfa/beta therapy when converted from more frequent dosing to either once every two weeks or once every four weeks with C.E.R.A. Maintenance refers to the ability of C.E.R.A. to keep dialysis patients' Hb levels within target range over a defined period of time.
In the studies, patients were randomized to continue their current treatment regimen or convert to C.E.R.A. once every two weeks or once every four weeks. The primary endpoint was the mean change in Hb between baseline and the evaluation period. (Evaluation occurred at week 28 or 29 following initiation of C.E.R.A. depending on the study protocol.)
In addition, subgroup analyses were conducted for the PROTOS and MAXIMA trials to determine the impact of age, gender and diabetic status on mean Hb levels during the evaluation period in patients receiving C.E.R.A. once every four weeks. In these trials, dosage was adjusted to maintain Hb plus or minus 1.0 g/dL of the baseline level.
Details for the studies are as follows:
-- SC C.E.R.A. (Continuous Erythropoietin Receptor Activator) Once Every 2 Weeks or Once Monthly Maintains Stable Hb Levels after Converting Directly from SC Epoetin 1-3 Times per Week in Patients with CKD on Dialysis (PROTOS) [SA-PO207]
The PROTOS study compared the efficacy of SC C.E.R.A. in maintaining stable Hb levels in dialysis patients converted directly from SC epoetin alfa or beta administered up to three times weekly to C.E.R.A. administered once every two weeks or once every four weeks. For patients receiving C.E.R.A once every two weeks, the mean difference in Hb from baseline was 0.52 g/dL in the evaluation period (weeks 29-36) and 0.68 g/dL during the follow-up period (weeks 37-52). For patients receiving C.E.R.A. once every four weeks the mean difference in Hb levels were 0.57g/dL for the evaluation period and 0.76 g/dL during follow-up. Mean difference in Hb from baseline for epoetin treated patients was 0.57 g/dL for the evaluation period and 0.68 g/dL during follow-up. These data demonstrate that once every four week dosing of C.E.R.A. was as effective as frequently dosed (1-3 times per week) epoetin alfa or beta.
-- SC C.E.R.A. (Continuous Erythropoietin Receptor Activator) Administered up to Once Monthly in Patients with CKD on Dialysis Maintain Adequate Hb Levels Regardless of Age, Gender or Diabetic Status (PROTOS) [SA-PO210]
In this subgroup analysis of the PROTOS trial, the mean Hb levels between patients taking C.E.R.A. once every four weeks and frequently dosed epoetin were similar regardless of age (patients
CERA administrat de pânã la o datã la patru sãptãmâni menþinut stabil în nivelurile de hemoglobinã de dializã pacienþii cu boalã renalã cronicã - C.E.R.A. Administered Up To Once Every Four Weeks Maintained Stable Hemoglobin Levels In Dialysis Patients With Chronic Kidney Disease - articole medicale engleza - startsanatate