Phase 2
N=21
Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis
Lupus Nephritis
Bottom Line
View on ClinicalTrials.gov: NCT00709722 ↗Enrolled (actual)
21
Serious AEs
38.1%
Results posted
Jan 2017
Primary outcome: Primary: Complete and Partial Response Rate — 55 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NKT-01 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nippon Kayaku Co., Ltd.
- Primary completion
- Apr 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete and Partial Response Rate |
55 | — |
| SECONDARY SELENA-SLEDAI Score |
16.9; 12.9; 13.7; 11.7 | — |
| SECONDARY Treatment Days With Corticosteroids of <= 7.5 mg/Day |
2.8; 18 | — |
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.
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 = 4000/uL.
- Receiving OCS ( 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.
Data sourced from ClinicalTrials.gov (NCT00709722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.