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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00805909

Enrollment

Registered

2008-12-10

Start date

2007-08-31

Completion date

2009-01-31

Last updated

2009-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Transplant Rejection

Brief summary

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

Interventions

DRUGNI-0401

5 daily infusions with escalating doses of NI-0401

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Nature,frequency,intensity,causality and seriousness of adverse events	Studay day 1 to week 6

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026