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OpenTrials
Completed

NCT Number: NCT00805909

NI-0401 in Patients With Acute 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.

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Key information

Conditions

Acute Renal Transplant Rejection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hôpital Necker

Paris, 75006, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NI-0401

Drug

5 daily infusions with escalating doses of NI-0401

Primary outcomes

  1. Nature,frequency,intensity,causality and seriousness of adverse events

    Time frame: Studay day 1 to week 6

Sponsors and collaborators

Lead sponsor

Light Chain Bioscience - Novimmune SA

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 10, 2008
Registry last updated
Jun 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.