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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: May 21, 2009
Last verified: July 2008

July 2, 2008
May 21, 2009
October 2003
April 2007   (final data collection date for primary outcome measure)
Complete and partial response [ Time Frame: The last day of 4th, 6th and 9th cycle ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00709722 on ClinicalTrials.gov Archive Site
  • SELENA-SLEDAI score [ Time Frame: The last day of the 4th, 6th and 9th cycle ] [ Designated as safety issue: No ]
  • Treatment days of corticosteroids <= 7.5 mg/day [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Leucopenia (>= grade 3), Infection, Other adverse events [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]
Same as current
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
Endpoint Classification: Safety/Efficacy Study
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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany
 
NCT00709722
SLE01-ENK
No
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