NI-0401 in Patients With Acute Renal Allograft Rejection

A Phase IIa, Open-Label, Dose-Titration, Multicenter Study to Assess the Safety and Preliminary Efficacy of NI-0401 in Patients With Acute Cellular Renal Allograft Rejection

The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.

Main inclusion Criteria:

• evidence of cellular rejection in a renal biopsy according to Bannff 97 criteria
• rise in Serum Creatinine concentration by >20% compared to baseline value

Main Exclusion Criteria:

• previous therapy with anti-CD3 mAB(OKT3) or anti-lymphocytes polyclonal antibodies (ATG, Atgam)
• patients with cardiac insufficiency or fluid overload
• severe HLA sensitization (>50% panel reactive antibodies prior transplantation)
• defined concomitant disease