At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 21 enrolled
Drug / intervention
NKT-01drug
Likely dose
NKT-01 0.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy Study on Deoxyspergualin (NKT-01) in Patients With Uncontrolled Lupus Nephritis Receiving Oral Corticosteroids and Prior Treatment of Standard Immunosuppressive Therapy
In Brief
A Phase 2 clinical trial evaluating NKT-01 for Lupus Nephritis. Completed, enrolled 21 participants across 6 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Nephritis
CountriesCzechia, Germany
Collaborators--
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2003
Primary CompletionApr 2007
First PostedJul 2008
TodayJul 2026
First PostedJul 3, 2008
Enrollment StartOct 1, 2003
Primary CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 18.0 years ago
Interventions
NKT-01drug
SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.