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NI-0401 in Patients With Acute Renal Allograft Rejection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00805909
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : June 9, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acute Renal Transplant Rejection Drug: NI-0401 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2007
Primary Completion Date : January 2009
Study Completion Date : January 2009

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



Primary Outcome Measures :
  1. Nature,frequency,intensity,causality and seriousness of adverse events [ Time Frame: Studay day 1 to week 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805909


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

Responsible Party: Penny Ward/Study Director, NovImmune
ClinicalTrials.gov Identifier: NCT00805909     History of Changes
Other Study ID Numbers: NI-0401-02
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: June 9, 2009
Last Verified: June 2009