A Study of Nulojix® (Belatacept) as Maintenance Immunosuppression in Kidney Transplant Recipients

Overview

About this study

The primary purpose of this study is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.

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

  • Men and women
  • Ages 18-75 
  • Adult recipients of a renal allograft from a living donor or a deceased donor between 6-60 months prior to enrollment 
  • Receiving a stable ( ≥ 1 month) regimen of Calcineurin inhibitor (CNI) [Cyclosporine A (CsA) or Tacrolimus (TAC)] with Mycophenolate mofetil (MMF) or Enteric Coated Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids
  • Stable renal function for 12 weeks prior to enrollment without new onset proteinuria 
  • Calculated glomerular filtration rate (cGFR) ≥ 30 and ≤ 75 mL/min/1.73 m2

Exclusion Criteria

  • Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown 
  • History of acute rejection within 3 months prior to enrollment 
  • History of antibody mediated rejection 
  • Positive T-cell lymphocytotoxic cross match 
  • Proteinuria > 1 g/day or > 0.5 g/day if diabetic

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-20206555

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