A Study of Obinutuzumab to Evaluate the Safety and Tolerability in Hypersensitized Adult Participants with End Stage Renal Disease Awaiting Transplantation

Overview

About this study

The purpose of this study of obinutuzumab administered as intravenous (IV) infusion in adults with end stage renal disease is to assess the safety and tolerability of the regimen at week 24 of the desensitization phase and at week 28 post kidney transplantation. All participants will be monitored for a minimum of 12 months following the last obinutuzumab infusion.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • End stage renal disease with a history of sensitizing events
  • United network for organ sharing (UNOS)-listed with at least one match run for a deceased donor kidney during the past year
  • Adults 18 to 65 years of age
  • Females of childbearing potential agree to remain abstinent or use two adequate methods of contraception during the treatment period and for at least 18 months after the last dose of study drug
  • Male participants agree to remain abstinent or use contraceptive measures and agreet to refrain from donating sperm during the treatment period and for at least 12 months after the last dose of study drug

 

Exclusion Criteria

  • Incomplete recovery from recent major surgery or < 12 weeks since major surgery prior to baseline and participants planned surgery within 24 weeks of baseline except for kidney transplantation
  • Pregnant or lactating women
  • Positive serum human chorionic gonadotropin (hCG) measured prior to the first obinutuzumab infusion
  • Primary or secondary immunodeficiency disease
  • Seropositivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or seropositivity for Hepatitis C
  • History of active or latent tuberculosis (TB) or suspicion of active TB
  • Known active infection of any kind or any major episode of infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks of baseline or completion of oral anti-infective agents within 2 weeks prior to baseline
  • Currently active alcohol or drug abuse or history of alcohol or drug abuse
  • Participants who received more than one organ transplant
  • Participants for synchronous organ transplant
  • Recipients of any live attenuated vaccine(s) within 1 month of the screening visit
  • Abnormal screening laboratory results
  • Participants with a history of major cardiovascular or pulmonary disease
  • Use of investigational agents within 12 weeks or five half-lives of randomization
  • Use of an anti-CD20 therapy within the past 12 months
  • Known contraindications to obinutuzumab
  • History of severe allergic or anaphylactic reactions to monoclonal antibodies or components of obinutuzumab infusion
  • Participants with ESRD on peritoneal dialysis

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20267879

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