drugset / Trial / NCT03325621

Phase 2a Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients

NCT03325621 ↗

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

EvaluationDrugModalityDoseRoute
Comparator PRS-080#022-DP Unknown 4 mg/kg Intravenous
Comparator PRS-080#022-DP Unknown 8 mg/kg Intravenous