NI-0401 in Patients With Acute Renal Allograft Rejection

Phase 2CompletedNCT00805909

Light Chain Bioscience - Novimmune SA12 enrolled

Overview

The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Renal Transplant Rejection

Interventions

NI-0401DRUG

5 daily infusions with escalating doses of NI-0401

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Necker

Paris, France

Outcomes

Primary Outcomes

Nature,frequency,intensity,causality and seriousness of adverse events

Time frame: Studay day 1 to week 6

Data from ClinicalTrials.gov

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