Trial Information

Summary: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects with ISN/RPS Class III or IV Lupus Nephritis

Lupus LUNAR Study

The LUNAR Study is seeking approximately 140 women and men, ages 16 to 75, with active kidney disease related to lupus. The study will evaluate whether or not the study drug is safe and whether or not it will help improve kidney function in lupus-related kidney disease.

Patient Inclusion Criteria: Inclusion Criteria Subjects must meet all of the following criteria to be eligible for study entry:

• Ability and willingness to provide written informed consent and comply with the schedule of protocol assessments
• Diagnosis of SLE according to current ACR criteria (at least four criteria must be present, one of which must be a positive ANA at a titer of = 1:160 at any time) (see Appendix E)
• Diagnosis of ISN/RPS 2003 Class III or IV LN, with either active or active/chronic disease Renal biopsy must have been done within the 12 months prior to screening. If the biopsy was performed > 3 months prior to screening, then an active urinary sediment, as evidenced by = 10 RBCs/HPF or the presence of red blood cell casts, must also be present.
• Proteinuria, as defined by a urine protein to creatinine ratio > 1.0
• 16 - 75 years of age
• For subjects of reproductive potential (males and females), use of effective contraception during the study Subjects must use a barrier method of contraception or an intra-uterine contraceptive device, unless abstinence is the chosen method of contraception. Subjects must be willing to practice this method of contraception while taking MMF and for 6 weeks after stopping MMF. In addition, subjects must be willing to practice this method of contraception for 1 year after the last dose of study drug or until peripheral B-cell recovery, whichever is longer.

Patient Exclusion Criteria: 4.1.3 Exclusion Criteria Subjects who meet any of the following criteria will be excluded:

1. Criteria Related to SLE
   • Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE
   • > 50% of glomeruli with sclerosis on renal biopsy
   • > 50% interstitial fibrosis on renal biopsy
   • Estimated GFR < 25 mL/min per 1.73 m2 (as calculated by the abbreviated MDRD equation, below) at screening or end-stage renal disease requiring dialysis or transplant Estimated GFR (mL/min per 1.73 m2) = 186 × (serum creatinine) 1.154
     • (age) 0.203
     • (0.742 if subject is female)
     • (1.210 if subject is Black)
   • Unstable subjects with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions

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Trial listings updated: June 1, 2008 at 6:32:51 AM