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

Lupus Nephritis Clinical Trial

Official title:

Safety and Efficacy Study on Deoxyspergualin (NKT-01) in Patients With Uncontrolled Lupus Nephritis Receiving Oral Corticosteroids and Prior Treatment of Standard Immunosuppressive Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709722
• Other study ID #: SLE01-ENK
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 2, 2008
• Last updated: May 21, 2009
• Start date: October 2003
• Est. completion date: April 2007

Study information

• Verified date: July 2008
• Source: Nippon Kayaku Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

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

Locations

Country	Name	City	State
Czech Republic	General Faculty Hospital	Prague
Germany	Universitatsklinikum Charite	Berlin
Germany	Universitat Frankfurt	Frankfurt
Germany	University of Heidelberg	Heidelberg
Germany	University Hospital Mannheim, Heidelberg University	Mannheim
Germany	University of Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
Nippon Kayaku Co.,Ltd.

Countries where clinical trial is conducted

Czech Republic,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete and partial response		The last day of 4th, 6th and 9th cycle	No
Secondary	SELENA-SLEDAI score		The last day of the 4th, 6th and 9th cycle	No
Secondary	Treatment days of corticosteroids <= 7.5 mg/day		Throughout study period	No
Secondary	Leucopenia (>= grade 3), Infection, Other adverse events		Throughout study period	Yes