drugset / Trial / NCT02570854

A Two-part Single- and Repeat-dose Study of CSJ137 in Anemic Chronic Hemodialysis Patients

NCT02570854 ↗

Phase 1 Completed 40 enrolled Novartis Pharmaceuticals
RandomizedSingle-groupOpen-labelTreatment

Summary

The study will assess the safety, tolerability and efficacy of CSJ137 in chronic hemodialysis patients. It is hypothesized that treatment with CSJ137 may improve the level of hemoglobin in patients on chronic hemodialysis with iron-restricted anemia while reducing the need for dosing with erythropoietin and intravenous iron in these patients.

Timeline

Start
2015-09-22
Primary completion
2020-05-13
Completion
2020-05-13

Drugs

EvaluationDrugModalityDoseRoute
Subject CSJ137 Unknown 0.01 mg/kg Intravenous
Subject CSJ137 Unknown 10 mg/kg Intravenous