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A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis

Study category: Kidney Disease & Hypertension

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Description

Each study subject will start with 12 weeks of treatment of MMF. After the 12 weeks of MMF, the subjects with an inadequate renal response may be randomized to one of the BMS-986165 treatment groups or placebo as add-on treatment to MMF. Subjects will be monitored and evaluated every 4 weeks for 52 weeks. Neither the subject or study staff will know which treatment was given until after the study has finished.

Details
Age

Adult

Eligibility

Males and females who are 18-75 years of age, and have had a biopsy-verified lupus nephritis within the last 3 months before screening.

Detailed Eligibility: Inclusion Criteria: -The UPCR needs to be equal or greater to 1.5 mg/mg with a 24 hour urine specimen. Patients not eligible for the study include: -Estimating eGFR of equal or less than 30 mL/minute -Dialysis within 12 months before screening -Kidney transplant patients -End-stage renal disease -Women who are pregnant or breastfeeding -A heart attack or myocardial infarction within 24 weeks before screening

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Locations

Renal Research Center
University of Colorado Hospital

Principal Investigator
Joshua Thurman

Joshua Thurman

Study ID

Protocol Number: 19-2904

More information available at ClinicalTrials.gov: NCT03943147

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