Systemic lupus erythrematosus (SLE) is an aggressive autoimmune disease. The chronic inflammatory processes involve many organs like the skin, lung, kidneys, central and peripheral nervous system, eyes, joints, bone marrow and blood cells, heart, and others. All organs can be affected. The diagnosis of SLE is based on the presence of composite clinical and serological markers. Nephritis is a major complication of SLE and is a strong determinant of morbidity and mortality. MedDRA version: 7.1 Le
Conditions
Interventions
Trade Name: Spanidin
Product Name: Desoxspergualin
Product Code: NKT01
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Gusperimus
CAS Number: 84937-45-1
Current Sponsor cod
Sponsors
Euro Nippon Kayaku GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) a diagnosis of SLE according to the ACR criteria (at least 4/11 ACR criteria to be fulfilled, see Appendix 2) , and 2) signs of active SLE nephritis must be present: - increasing urinary protein excretion of 1g or more per 24 hours (if initially normal values) or an increase of >50% over the initially elevated values and/or - active urinary sediment and/or - impaired renal function due to SLE nephritis (elevated serum creatinine – if initially normal values – or >50% increase of serum creatinine levels if elevated before onset of renal flare), and/or Either the above-mentioned parameters of SLE nephritis must be present or - signs of active lupus nephritis in renal biopsy (any renal biopsy in the past 2 years within the scope of SLE disease) Signs must be sufficient to diagnose active lupus nephritis (i.e. active urinary sediment alone will not be sufficient); 3) serum creatinine concentration of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) chronic infection of HIV, Hepatitis B, Hepatitis C 2) acute infection including fungal, viral, bacterial or protozoal diseases 3) liver toxicity (CTC class 2 and higher). No adequate liver function (total bilirubin > 25 mmol/L =1.4 mg/dL unless explained otherwise (e.g. inherited, hemolysis), SGOT > 2.5 x N, SGPT > 2.5 x N) 4) pregnant or lactating women 5) female patients of child bearing age without safe method of contraception 6) anemia (hemoglobulin < 8.0 g/dL), leukocytopenia (leukocytes < 4000/µL unless attributable to SLE: leukocytes < 2000/µL), thrombocytopenia (platelets < 50000/µL) 7) neutrophils below 1000/µL 8) hypogammaglobulinemia below 400 mg/dL of serum IgG 9) any other condition that in the eyes of the investigator may render the patient unsuitable for participation into the study. This especially includes major and active SLE organ involvement other than the kidney. Patients with SLE involvement of the central nervous system must not be included into the study. 10) history of malignancy 11) Current participation in another trial or at least 6 months since participating in a similar trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a phase I/II pilot study in SLE patients with uncontrolled lupus nephritis with NKT-01 in addition to OCS (£ 1.0 mg/kg/day, a maximum dose of 80 mg/day). Its purpose is to establish that dose of NKT-01 which, in combination with OCS (LE 1.0 mg/kg/day) leads to complete response during a minimum of 6 cycles of treatment without causing WHO grade 3 leukopenia (WBC < 2x109/L). ;Secondary Objective: ;Primary end point(s): The response rate as the final outcome of the study is the primary endpoint of the study. It is a 4 point scale: (1) complete response (2) partial response (3) stable disease (4) treatment failure | — |
Countries
Czech Republic
Outcome results
None listed