NCT00709722

Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis

Safety and Efficacy Study on Deoxyspergualin (NKT-01) in Patients With Uncontrolled Lupus Nephritis Receiving Oral Corticosteroids and Prior Treatment of Standard Immunosuppressive Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Nippon Kayaku Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	NKT-01	SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.

Timeline

• Start date: 2003-10-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2008-07-03
• Last updated: 2017-01-10
• Results posted: 2017-01-10

Locations

6 sites across 2 countries: Czechia, Germany