- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00709722
Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis
November 13, 2016 updated by: Nippon Kayaku Co., Ltd.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Prague, Czech Republic, 12808
- General Faculty Hospital
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Berlin, Germany, 10117
- Universitätsklinikum Charité
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Frankfurt, Germany, 60590
- Universität Frankfurt
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Heidelberg, Germany, 69120
- University of Heidelberg
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Mannheim, Germany, 68135
- University Hospital Mannheim, Heidelberg University
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Regensburg, Germany
- University of Regensburg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
NKT-01
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SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Complete and Partial Response Rate
Time Frame: Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks
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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.
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Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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SELENA-SLEDAI Score
Time Frame: Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks
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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.
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Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks
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Treatment Days With Corticosteroids of <= 7.5 mg/Day
Time Frame: 1st and 9th Cycle
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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. |
1st and 9th Cycle
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hanns-Martin Lorenz, Professor, Heidelberg University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
July 2, 2008
First Submitted That Met QC Criteria
July 2, 2008
First Posted (Estimate)
July 3, 2008
Study Record Updates
Last Update Posted (Estimate)
January 10, 2017
Last Update Submitted That Met QC Criteria
November 13, 2016
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Nephritis
- Lupus Nephritis
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Antibiotics, Antineoplastic
- Radiation-Protective Agents
- Gusperimus
Other Study ID Numbers
- SLE01-ENK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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