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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Lupus Nephritis
 Drug: NKT-01
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Nippon Kayaku Co.,Ltd.:

Primary Outcome Measures:
  • Complete and partial response [ Time Frame: The last day of 4th, 6th and 9th cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: October 2003
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
NKT-01
 Drug: NKT-01
SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.
Other Name: Deoxyspergualin, gusperimus

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709722

Locations
Czech Republic
General Faculty Hospital
Prague, Czech Republic, 12808
Germany
Universitatsklinikum Charite
Berlin, Germany, 10117
Universitat Frankfurt
Frankfurt, Germany, 60590
University of Heidelberg
Heidelberg, Germany, 69120
University Hospital Mannheim, Heidelberg University
Mannheim, Germany, 68135
University of Regensburg
Regensburg, Germany
Sponsors and Collaborators
Nippon Kayaku Co.,Ltd.
Investigators
Principal Investigator: Hanns-Martin Lorenz, Professor University of Heidelberg
  More Information

No publications provided by Nippon Kayaku Co.,Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Peter A. Heinzel, Ph.D., Clinical and Scientific Department, Euro Nippon Kayaku GmbH
ClinicalTrials.gov Identifier: NCT00709722     History of Changes
Other Study ID Numbers: SLE01-ENK
Study First Received: July 2, 2008
Last Updated: May 21, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control

Keywords provided by Nippon Kayaku Co.,Ltd.:
Lupus nephritis
Deoxyspergualin
Immunosuppression

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Gusperimus
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 21, 2013