drugset / Trial / NCT02754167

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

NCT02754167 ↗

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

EvaluationDrugModalityDoseRoute
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