NI-0401 in Patients With Acute Renal Allograft Rejection

This study has been completed.
Information provided by:
NovImmune SA Identifier:
First received: December 8, 2008
Last updated: June 8, 2009
Last verified: June 2009

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

Condition Intervention Phase
Acute Renal Transplant Rejection
Drug: NI-0401
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Further study details as provided by NovImmune SA:

Primary Outcome Measures:
  • Nature,frequency,intensity,causality and seriousness of adverse events [ Time Frame: Studay day 1 to week 6 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: August 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NI-0401
5 daily infusions of escalating doses of NI-0401
Drug: NI-0401
5 daily infusions with escalating doses of NI-0401


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00805909

Hôpital Necker
Paris, France, 75006
Sponsors and Collaborators
NovImmune SA
  More Information

No publications provided

Responsible Party: Penny Ward/Study Director, NovImmune Identifier: NCT00805909     History of Changes
Other Study ID Numbers: NI-0401-02
Study First Received: December 8, 2008
Last Updated: June 8, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Ministry of Health
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency processed this record on April 17, 2014