Conditions: Lupus Nephritis
Keywords: Lupus nephritis Deoxyspergualin Immunosuppression
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 21
Healthy volunteers: no

Brief summary:
The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.

Detailed description:
The purpose of this phase I/II study ia to establish that dose of NKT-01 which leads to complete response during a minimum of 6 cycles of treatment without causing WHO grade 3 leukopenia (WBC \< 2x10\^9/L). The patients suffered from uncontrolled lupus nephritis (LN) and took OCS (\<= 1.0 mf/kf/day, a maximum dose of 80 mg/day) in addition to NKT-01. Therefore the aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.

Arms:
arm 1: NKT-01

Interventions: intervention 1: NKT-01
Intervention descriptions: intervention 1: SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.

Protocol document: