Clinical Trial: Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Efficacy Study on Deoxyspergualin (NKT-01) in Patients With Uncontrolled Lupus Nephritis Receiving Oral Corticosteroids and Prior Treatment of Standard Immunosu
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 Summary: 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.
Sponsor: Nippon Kayaku Co.,Ltd.
Current Primary Outcome: Complete and Partial Response Rate [ Time Frame: Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks ]
Original Primary Outcome: Complete and partial response [ Time Frame: The last day of 4th, 6th and 9th cycle ]
Current Secondary Outcome:
- SELENA-SLEDAI Score [ Time Frame: Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks ]The "Safety of Estrogen in Lupus Erythematosus National Assessment - systemic lupus erythematosus disease activity index' (SELENA-SLEDAI) document the current activity of SLE/LN. It contains 24 items (descriptors), which are differently weighed. The score has a total range of 0 - 105. As a maximum 105 score points can be reached meaning the worst disease activity.
- Treatment Days With Corticosteroids of <= 7.5 mg/Day [ Time Frame: 1st and 9th Cycle ]
Entry to the study was permitted for patients with doses of oral corticosteroids (OCS) of <= 1.0 mg/kg/day (maximum dose 80 mg/day).
OCS dosage was maintained, decreased or increased according to the response to DSG.
The number of days on which the OCS dose was <= 7.5 mg/day was counted in each cycle.
Original Secondary Outcome:
- SELENA-SLEDAI Score [ Time Frame: The last day of the 4th, 6th and 9th cycle ]
- Treatment days of corticosteroids <= 7.5 mg/day [ Time Frame: Throughout study period ]
- Leucopenia (>= grade 3), Infection, Other adverse events [ Time Frame: Throughout study period ]
Information By: Nippon Kayaku Co.,Ltd.
Dates:
Date Received: July 2, 2008
Date Started: October 2003
Date Completion:
Last Updated: November 13, 2016
Last Verified: July 2008