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 - Northwestern Memorial Hospital - Chicago

Immune Tolerance and Alloreactivity in Liver Transplant Recipients

Immune Tolerance and Alloreactivity in Liver Transplant Recipients on Different Monotherapy Immunosuppressive Agents

Purpose:

This study is a pilot investigation comparing immune tolerance and alloreactivity profiles in Liver transplant recipients on Monotherapy IS or being converted to rapamycin or MMF Monotherapy, to determine baseline tolerogenic properties of the different IS agents and support larger scale investigation if significant trends are observed.

In addition, this data may lead to protocol development involving the selection of patients on specific agents for further immune tolerance study, conversion, minimization and/or withdrawal.

  • Primary Aim #1: To demonstrate a higher percentage of FOXP3 T regulatory cells in stable liver transplant recipients on rapamycin or MMF monotherapy compared to CNI monotherapy

  • Primary Aim #2 : To demonstrate the development of a higher percentage of FOXP3 T regulatory cells in liver transplant recipients after conversion from CNI to rapamycin or MMF monotherapy

  • Secondary Aim #1: To demonstrate a higher percentage of immunophenotypic markers associated with regulatory T cell production (dendritic cell ratios, soluble HLA G) in stable liver transplant recipients on rapamycin or MMF monotherapy compared to CNI monotherapy

  • Secondary Aim #2: To demonstrate the development of a higher percentage of immunophenotypic markers associated with regulatory T cell production (dendritic cell ratios, soluble HLA G) in liver transplant recipients after conversion from CNI to rapamycin or MMF monotherapy

  • Secondary Aim #3: To document improvement in adverse CNI side effects (hypertension, hyperlipidemia, renal insufficiency, diabetes, neuropathy) after conversion to rapamycin or MMF monotherapy

  • Secondary Aim #4: To document the development of any adverse rapamycin (oral ulcers, edema, pancytopenia, gastrointestinal dysfunction) or MMF (pancytopenia, gastrointestinal dysfunction) side effects after conversion

Inclusion Criteria:

  • Age ≥18 years

  • Orthotopic or Living-Related liver transplant (LT) recipient

  • Monotherapy patients: > 6 months with stable graft function on current monotherapy (CNI, MMF, or rapamycin)

  • Converting patients: CNI therapy converting to rapamycin or MMF monotherapy and > 6 months of stable graft function.

  • >1 years post-LT without an acute rejection episode or chronic rejection

  • Normal liver function tests (no recurrent HCV, chronic rejection, autoimmune hepatitis, etc.)

Sponsor:

Divisional

Principle Investigator:

Josh Levitsky, MD 

Cost:

None

IRB Project Number:

1783-011

Contact:

Anne Rosen, RN
312-503-0444

Last UpdateMarch 25, 2011
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