Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to evaluate the safety and effectiveness of BMS-986165compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).

Official Title

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

Keywords

Lupus Nephritis Nephritis BMS-986165 Dose 1 Dose 2

Eligibility

For people ages 18-75

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria for SLE
  • Renal biopsy confirming a histologic diagnosis of active LN: International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III (A or A/C), IV-S (A or A/C), or IV-G (A or A/C); or Class V (in combination with Class III or IV)
  • Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg

Exclusion Criteria:

  • Pure ISN/RPS Class V membranous LN
  • Screening estimated glomerular filtration rate (eGFR; calculated using the Modification of Diet in Renal Disease [MDRD] equation) ≤30 mL/min/1.73 m2
  • Dialysis within 12 months before screening or plans for dialysis within 6 months after enrollment in the study

Other protocol defined inclusion/exclusion criteria could apply

Locations

  • The Regents of The University of California accepting new patients
    Los Angeles California 90095 United States
  • The Nephrology Group accepting new patients
    Fresno California 93720 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting Investigator Inquiry Form FDA Safety Alerts and Recalls
ID
NCT03943147
Phase
Phase 2
Study Type
Interventional
Last Updated