A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.
| Status: | Terminated |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2007 |
| End Date: | April 2008 |
A Randomized, Open Label Study to Compare the Effect of Monthly Injections of Mircera Versus Epoetin Alfa on Hemoglobin Levels in Peritoneal Dialysis Patients Who Self-inject or Receive In-center Injections
This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal
dialysis patients who self-inject at home or receive in-centre injections. The safety of
subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be
assessed. Eligible patients will be randomized either to receive monthly sc injections of
Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360
micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be
permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study
treatment is 3-12 months, and the target sample size is 100-500 individuals.
dialysis patients who self-inject at home or receive in-centre injections. The safety of
subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be
assessed. Eligible patients will be randomized either to receive monthly sc injections of
Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360
micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be
permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study
treatment is 3-12 months, and the target sample size is 100-500 individuals.
Inclusion Criteria:
- adult patients, >=18 years of age;
- chronic kidney disease stage V;
- on peritoneal dialysis for 3 months prior to screening;
- on epoetin alfa sc >=3 months prior to screening.
Exclusion Criteria:
- patients expecting to change dialysis modality over course of study;
- patients hospitalized during previous 3 months for any clinically significant
condition;
- active malignancy;
- bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within
3 months prior to screening;
- transfusion of red blood cells within 3 months prior to screening.
We found this trial at
62
sites
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