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 ]

A four-point scale was defined: complete response (CR), partial response (PR), stable disease (SD) or treatment failure (TF). The response criteria were defined prior to the start of the study: for a CR, PR or SD prednisone had to be decreased to <= 7.5 mg/day, a higher dosage was automatically classified as TF. The presence of urinary erythrocyte or granular casts excluded CR. As the baseline activity of every patient is different, it was necessary to define baseline proteinuria (g/24 h) or kidney function (estimated glomerular filtration rate) as the reference value for the definition of response for every patient individually. The baseline was defined as the renal function and proteinuria level before the onset of the recent LN flare which qualified the patient for the study. Response was determined as the ratio of the proteinuria or kidney function at cycle 4, 6 or 9 to the baseline values of the individual patient.


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