NI-0401 in Patients With Acute Renal Allograft Rejection

Light Chain Bioscience

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Renal Transplant Rejection

Treatments: Drug: NI-0401

Study type: Interventional

Funder types: Industry

Identifiers

NCT00805909

NI-0401-02

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

NI-0401

Experimental group

Description:

5 daily infusions of escalating doses of NI-0401

Treatment:

Drug: NI-0401