drugset / Trial / NCT02754167
Phase Ib Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Anticalins® are engineered human proteins that are able to bind specific target molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for the treatment of anemia of chronic disease. This Phase Ib study shall investigate the safety, pharmacokinetics and pharmacodynamics of a single administration of PRS-080#022-DP in anemic stage 5 chronic kidney disease patients undergoing hemodialysis.
Timeline
- Start
- 2016-06-06
- Primary completion
- 2017-02-06
- Completion
- 2017-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PRS-080#022-DP | Unknown | 2 mg/kg | Intravenous |
| Subject | PRS-080#022-DP | Unknown | 4 mg/kg | Intravenous |
| Subject | PRS-080#022-DP | Unknown | 8 mg/kg | Intravenous |