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Biomarker-guided Reduction of Immunosuppression in Liver Transplant Recipients (BRITRE)

ConditionLiver Diseases
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

Researchers are interested in determining whether it is safe to reduce anti-rejection medication by approximately 50% after liver transplantation and whether special blood tests called biomarkers can identify early signs that the body is starting to attack the new liver before it gets hurt.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age >18 years old. 2. >12 months and < 24 months post transplantation. 3. Liver transplant for non-immune liver disease. 4. For participants with HCV (history of HCV or donor with history of HCV): must be HCV PCR negative and have documented history of Sustained Viral Response to antiviral therapy (>=12 weeks) or documented, persistent spontaneous clearance of HCV.

Disqualifiers

Inability or unwillingness of a participant to give documented informed consent or comply with the study protocol.

History of retransplantation or multi-organ transplantation.

Split liver transplantation, except when involving a right tri-segment.

Liver transplantation indication of autoimmune disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • miRNA Biomarker-Guided Immunosuppression Minimization

    Other intervention

    Participants undergo calcineurin inhibitor (CNI) dose reduction with immunosuppression minimization guided by a miRNA-based biomarker in conjunction with conventional biochemical monitoring.

  • Conventional Biochemical Monitoring-Guided Immunosuppression Minimization

    Other intervention

    Participants undergo calcineurin inhibitor (CNI) dose reduction with immunosuppression minimization guided by conventional biochemical monitoring alone.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: miRNA Biomarker-Guided Immunosuppression MinimizationExperimental treatment 1 intervention
Group B: Conventional Biochemical Monitoring-Guided Immunosuppression MinimizationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Successful 50% Immunosuppressive CNI reduction

Successful 50% Immunosuppressive CNI reduction: Successful timepoint. protocol-directed 50% immunosuppression (IS) reduction up to the 12 month (\~52 week).

Time frame
Up to 12months
2

Allograft status: Rejection/graft loss

Allograft status: Rejection/graft loss: Freedom from Rejection/graft loss for 12 months (\~52 weeks) after study enrollment. This endpoint will be the time to first occurrence of any of the following allograft (rejection or organ failure) events: * Biopsy-proven acute rejection (BPAR) * Clinical rejection (rejection treatment administered in the absence of BPAR) * Death or graft loss

Time frame
12 months after study enrollment

Secondary outcomes

1

Decrease or improvement in renal function

Decrease or improvement in renal function defined as: (baseline eGFR) - (eGFR at 1-year post-randomization).

Time frame
1 year post randomization
2

For those with a baseline eGFR 30-90 mL/min/1.73 m2: absence of a 10% or greater decrease in eGFR

• For those with a baseline eGFR 30-90 mL/min/1.73 m2: absence of a 10% or greater decrease in eGFR

Time frame
1 year post randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: