Status:
COMPLETED
NI-0401 in Patients With Acute Renal Allograft Rejection
Lead Sponsor:
Light Chain Bioscience - Novimmune SA
Conditions:
Acute Renal Transplant Rejection
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00805909
Start Date
August 1 2007
End Date
January 1 2009
Last Update
June 9 2009
Active Locations (1)
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1
Hôpital Necker
Paris, France, 75006