NI-0401 in Patients With Acute Renal Allograft Rejection

June 8, 2009 updated by: Light Chain Bioscience - Novimmune SA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75006
        • Hopital Necker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NI-0401
5 daily infusions of escalating doses of NI-0401
Drug: NI-0401
5 daily infusions with escalating doses of NI-0401

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Light Chain Bioscience - Novimmune SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

December 8, 2008

First Submitted That Met QC Criteria

December 9, 2008

First Posted (Estimate)

December 10, 2008

Study Record Updates

Last Update Posted (Estimate)

June 9, 2009

Last Update Submitted That Met QC Criteria

June 8, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • NI-0401-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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