drugset
drugset / Trial / NCT03663335

Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients

NCT03663335 ↗

Phase 2 Completed 418 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

Summary

This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.

Timeline

Start
2018-11-28
Primary completion
2021-10-29
Completion
2021-10-29

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tacrolimus Small molecule — —
Subject iscalimab Monoclonal antibody 300 mg Intravenous
Subject iscalimab Monoclonal antibody 450 mg Intravenous
Subject iscalimab Monoclonal antibody 600 mg Intravenous
Background Basiliximab Monoclonal antibody — Intravenous
Background Mycophenolate Mofetil Small molecule 250 mg Oral
Background Mycophenolate Mofetil Small molecule 500 mg Oral
Background Thymoglobulin Protein / enzyme biologic — Intravenous
Background mycophenolic acid Small molecule — Oral

Indications

No indication recorded.