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

Status

Completed

Conditions

Intervention / Treatment

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

  • Czech Republic
      • Prague, Czech Republic, 12808
        • General Faculty Hospital
  • Germany
      • Berlin, Germany, 10117
        • Universitätsklinikum Charité
      • Frankfurt, Germany, 60590
        • Universität Frankfurt
      • Heidelberg, Germany, 69120
        • University of Heidelberg
      • Mannheim, Germany, 68135
        • University Hospital Mannheim, Heidelberg University
      • Regensburg, Germany
        • University of Regensburg

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
Experimental: 1
NKT-01
Drug: NKT-01
SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.
Other Names:
  • Deoxyspergualin, gusperimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks
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.
1st and 9th Cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nippon Kayaku Co., Ltd.

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.

General Publications

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

Keywords

Additional Relevant MeSH Terms

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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