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. Identifier: NCT00805909
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : June 9, 2009
Information provided by:
NovImmune SA

December 8, 2008
December 10, 2008
June 9, 2009
August 2007
January 2009   (Final data collection date for primary outcome measure)
Nature,frequency,intensity,causality and seriousness of adverse events [ Time Frame: Studay day 1 to week 6 ]
Same as current
Complete list of historical versions of study NCT00805909 on Archive Site
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NI-0401 in Patients With Acute Renal Allograft Rejection
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.
Not Provided
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Renal Transplant Rejection
Drug: NI-0401
5 daily infusions with escalating doses of NI-0401
Experimental: NI-0401
5 daily infusions of escalating doses of NI-0401
Intervention: Drug: NI-0401
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Penny Ward/Study Director, NovImmune
NovImmune SA
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NovImmune SA
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP