drugset / Trial / NCT00542568
Safety and Efficacy of Sustained Erythropoietin Therapy
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purposes of this study are to assess safety, efficacy, and subject satisfaction of EPODURE Biopump (an autologous dermal biopump capable of sustained secretion of therapeutic EPO in the body, using a small tissue explant from the patient's own skin) treatment in Chronic Kidney Disease (CKD) patients over a period of up to six (6) months.
Timeline
- Start
- 2008-08
- Primary completion
- 2012-07
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EPODURE | Unknown | 18 iu/kg | Subcutaneous |
| Subject | EPODURE | Unknown | 25 iu/kg | Subcutaneous |
| Subject | EPODURE | Unknown | 35 iu/kg | Subcutaneous |
| Subject | EPODURE | Unknown | 45 iu/kg | Subcutaneous |
| Subject | EPODURE | Unknown | 55 iu/kg | Subcutaneous |
| Subject | EPODURE | Unknown | 65 iu/kg | Subcutaneous |