Clinical Trials Logo

Clinical Trial Summary

The purpose of the study is to identify kidney transplant patients that can be transitioned from multi-drug immunosuppression therapy to Belatacept monotherapy, using cell free DNA and gene expression as markers of immune quiescence. The primary objective will be to determine if donor derived-cell free DNA (AlloSure) can be utilized to facilitate Belatacept monotherapy, and to determine if Belatacept is safe and effective as immunosuppression in kidney transplant recipients. The secondary objective is to determine the utility of AlloMap as a predictor of immune quiescence and tolerance of immunosuppressive de-escalation to Belatacept monotherapy, and to evaluate the performance of iBox in predicting adverse outcomes in patients transitioned to Belatacept monotherapy


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Kidney Transplant Immunosuppression

NCT number NCT04786067
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact David Wojciechowski, DO
Phone 214-645-8300
Email David.Wojciechowski@UTSouthwestern.edu
Status Recruiting
Phase Phase 4
Start date July 28, 2021
Completion date March 30, 2026

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06336863 - Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression N/A
Recruiting NCT06114953 - Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients Phase 4
Terminated NCT01424345 - The Role of ImmuKnow® in the Management of Immunosuppressants in the Renal Transplant Patient Phase 4