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

This study has been completed.
Sponsor:
Information provided by:
Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00709722
First received: July 2, 2008
Last updated: November 13, 2016
Last verified: July 2008

July 2, 2008
November 13, 2016
October 2003
April 2007   (Final data collection date for primary outcome measure)
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.
Complete and partial response [ Time Frame: The last day of 4th, 6th and 9th cycle ]
Complete list of historical versions of study NCT00709722 on ClinicalTrials.gov Archive Site
  • 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.

  • 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 ]
Not Provided
Not Provided
 
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
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.
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.
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lupus Nephritis
Drug: NKT-01
SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.
Other Name: Deoxyspergualin, gusperimus
Experimental: 1
NKT-01
Intervention: Drug: NKT-01
Lorenz HM, Schmitt WH, Tesar V, Müller-Ladner U, Tarner I, Hauser IA, Hiepe F, Alexander T, Woehling H, Nemoto K, Heinzel PA. Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin: an open-label dose escalation study. Arthritis Res Ther. 2011 Mar 1;13(2):R36. doi: 10.1186/ar3268.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
April 2007
April 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females aged 18-70 years.
  • A diagnosis of SLE according to the ACR criteria (at least 4/11 criteria).
  • Sufficient signs to diagnose active SLE nephritis.
  • Serum creatinine concentration of <= 5.0 mg/dL.
  • Leucocyte counts >= 4000/uL.
  • Receiving OCS (<= 1.0 mg/kg/day; a maximum dose of 80 mg/day).
  • Prior treatment with cyclophosphamide, azathioprine, cyclosporin A, or any other immunosuppressive drugs.

Exclusion Criteria:

  • Chronic infection of HIV, Hepatitis B, Hepatitis C.
  • Acute infection including fungal, viral, bacterial or protozoal diseases.
  • Liver toxicity (WHO CTC class 2 and higher). No adequate liver function (total bilirubin > 25 umol/L = 1.4 mg/dL unless explained otherwise (e.g. inherited, hemolysis), SGOT > 2.5 x N, SGPT > 2.5 x N).
  • Pregnant or lactating women
  • Female patients of child bearing age without safe method of contraception.
  • Anemia (hemoglobin < 8.0 g/dL), leucopenia (leucocytes < 4000/uL unless attributable to SLE: leucocytes < 2000/uL), thrombocytopenia (platelets < 50000/uL).
  • Neutrophils below 1000/uL.
  • Hypogammaglobulinemia below 400 mg/dL of serum IgG.
  • Any other condition that in the eyes of the investigator might have rendered the patient unsuitable for participation in the study. This especially includes major and active SLE organ involvement other than the kidney. Patients with SLE involvement of the central nervous system are not allowed to be included into the study.
  • History of malignancy.
  • Current participation in another trial or lass than 6 months since participation in a similar trial.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany
 
 
NCT00709722
SLE01-ENK
No
Not Provided
Not Provided
Not Provided
Peter A. Heinzel, Ph.D., Clinical and Scientific Department, Euro Nippon Kayaku GmbH
Nippon Kayaku Co.,Ltd.
Not Provided
Principal Investigator: Hanns-Martin Lorenz, Professor Heidelberg University
Nippon Kayaku Co.,Ltd.
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP