Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy Study on Deoxyspergualin (NKT-01) in Patients With Uncontrolled Lupus Nephritis Receiving Oral Corticosteroids and Prior Treatment of Standard Immunosuppressive Therapy|
- 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.
- 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.
|Study Start Date:||October 2003|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.
Other Name: Deoxyspergualin, gusperimus
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709722
|General Faculty Hospital|
|Prague, Czech Republic, 12808|
|Berlin, Germany, 10117|
|Frankfurt, Germany, 60590|
|University of Heidelberg|
|Heidelberg, Germany, 69120|
|University Hospital Mannheim, Heidelberg University|
|Mannheim, Germany, 68135|
|University of Regensburg|
|Principal Investigator:||Hanns-Martin Lorenz, Professor||Heidelberg University|