drugset / Trial / NCT03325621
Phase 2a Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Anticalin® proteins 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 pilot Phase 2a study shall investigate the safety, pharmacokinetics and pharmacodynamics of repeated administrations of PRS-080#022-DP in anemic stage 5 chronic kidney disease (CKD) patients undergoing hemodialysis.
Timeline
- Start
- 2017-09-30
- Primary completion
- 2019-03-30
- Completion
- 2019-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | PRS-080#022-DP | Unknown | 4 mg/kg | Intravenous |
| Comparator | PRS-080#022-DP | Unknown | 8 mg/kg | Intravenous |