Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE December 8, 2008
First Posted Date  ICMJE December 10, 2008
Last Update Posted Date June 9, 2009
Study Start Date  ICMJE August 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2008)
Nature,frequency,intensity,causality and seriousness of adverse events [ Time Frame: Studay day 1 to week 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NI-0401 in Patients With Acute Renal Allograft Rejection
Official Title  ICMJE 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
Brief Summary The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Renal Transplant Rejection
Intervention  ICMJE Drug: NI-0401
5 daily infusions with escalating doses of NI-0401
Study Arms  ICMJE Experimental: NI-0401
5 daily infusions of escalating doses of NI-0401
Intervention: Drug: NI-0401
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 9, 2008)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00805909
Other Study ID Numbers  ICMJE NI-0401-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Penny Ward/Study Director, NovImmune
Study Sponsor  ICMJE NovImmune SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NovImmune SA
Verification Date June 2009

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