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

NCT ID: NCT00709722

Last Updated: 2017-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2007-04-30

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.

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.

Conditions

Lupus Nephritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

NKT-01

Group Type: EXPERIMENTAL

NKT-01

Intervention Type: DRUG

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

Interventions

NKT-01

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

Intervention Type: DRUG

Other Intervention Names

Deoxyspergualin, gusperimus

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nippon Kayaku Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Euro Nippon Kayaku GmbH

Principal Investigators

Hanns-Martin Lorenz, Professor

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

General Faculty Hospital

Prague, , Czechia

Universitatsklinikum Charite

Berlin, , Germany

Universitat Frankfurt

Frankfurt, , Germany

University of Heidelberg

Heidelberg, , Germany

University Hospital Mannheim, Heidelberg University

Mannheim, , Germany

University of Regensburg

Regensburg, , Germany

Countries

Czechia; Germany

References

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.

Reference Type: DERIVED

PMID: 21356124 (View on PubMed)

Other Identifiers

SLE01-ENK

Identifier Type: -

Identifier Source: org_study_id