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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
Results First Received: April 13, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lupus Nephritis
Intervention: Drug: NKT-01

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 6 sites in Germany and Czech Republic from 2003 to 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Deoxyspergualin SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles

Participant Flow:   Overall Study
    Deoxyspergualin
STARTED   21 
COMPLETED   20 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population

Reporting Groups
  Description
Deoxyspergualin SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles

Baseline Measures
   Deoxyspergualin 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      20 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 31.3 
 (19 to 46) 
Gender 
[Units: Participants]
Count of Participants
 
Female      17  85.0% 
Male      3  15.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      20 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
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1.  Primary:   Complete and Partial Response Rate   [ Time Frame: Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks ]

2.  Secondary:   SELENA-SLEDAI Score   [ Time Frame: Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks ]

3.  Secondary:   Treatment Days With Corticosteroids of <= 7.5 mg/Day   [ Time Frame: 1st and 9th Cycle ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Pharmaceuticals Group
Organization: Nippon Kayaku Co., Ltd.
phone: +81-3-6731-5200


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
Results First Received: April 13, 2016
Last Updated: November 13, 2016