NI-0401 in Patients With Acute Renal Allograft Rejection

Phase 1

Completed

• Conditions: Acute Renal Transplant Rejection
• Interventions: Drug: NI-0401

• Registration Number: NCT00805909
• Lead Sponsor: Light Chain Bioscience - Novimmune SA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-08
• Last Update Posted: 2009-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NI-0401	NI-0401	5 daily infusions of escalating doses of NI-0401

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Necker; 🇫🇷 Paris, France