Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis

NCT00709722 | Completed Phase 1 Results

• 1 other identifier: SLE01-ENK
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Lupus Nephritis

Keywords

Lupus nephritis; Deoxyspergualin; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• Complete and Partial Response Rate

  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 Outcomes (2)

• SELENA-SLEDAI Score

  Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks

• Treatment Days With Corticosteroids of <= 7.5 mg/Day

  1st and 9th Cycle

Study Arms (1)

1

EXPERIMENTAL

NKT-01

Drug: NKT-01

Interventions

NKT-01 DRUG

SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.

Also known as: Deoxyspergualin, gusperimus

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nippon Kayaku Co., Ltd.: lead

Study Sites (6)

General Faculty Hospital

Prague, 12808, Czechia

Location

Universitatsklinikum Charite

Berlin, 10117, Germany

Location

Universitat Frankfurt

Frankfurt, 60590, Germany

Location

University of Heidelberg

Heidelberg, 69120, Germany

Location

University Hospital Mannheim, Heidelberg University

Mannheim, 68135, Germany

Location

University of Regensburg

Regensburg, Germany

Location

Related Publications (1)

• Lorenz HM, Schmitt WH, Tesar V, Muller-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.

  PMID: 21356124 DERIVED

MeSH Terms

Conditions

Lupus Nephritis

Interventions

gusperimus

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Pharmaceuticals Group
• Organization: Nippon Kayaku Co., Ltd.

+81-3-6731-5200

Study Officials

• Hanns-Martin Lorenz, Professor

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 3, 2008
• Study Start: October 1, 2003
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: January 10, 2017
• Results First Posted: January 10, 2017

Record last verified: 2008-07

Locations

CZ (1); DE (5)