NI-0401 in Patients With Acute Renal Allograft Rejection

This study has been completed.
Sponsor:
Information provided by:
NovImmune SA
ClinicalTrials.gov Identifier:
NCT00805909
First received: December 8, 2008
Last updated: June 8, 2009
Last verified: June 2009
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805909

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

No publications provided

Responsible Party: Penny Ward/Study Director, NovImmune
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on September 22, 2014