Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03874286
Other study ID # IRB# 16-006453
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2017
Est. completion date April 30, 2020

Study information

Verified date May 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.


Description:

The study is a prospective, observational study utilizing peripheral blood assays that will be collected at time points that are considered standard of care at most institutions. 100 participants will be enrolled in study. Participants will have peripheral blood collected at 4 months and 12 months after liver transplant, as well as any for cause time points. Participants will also have liver biopsies collected at these time points. The results from the liver biopsies will be used in correlation with the results from the peripheral blood assays.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who have given informed consent and are willing to comply with the protocol, including the use of their peripheral blood specimens and data for subsequent research. - Patients with increased risk of rejection. Patients must meet at least one of the following criteria: 1. Autoimmune etiology of the original liver disease (autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis) 2. Recipients of donation-after-cardiac death (DCD) donors 3. Recipients of simultaneous liver-kidney transplantation 4. Positive crossmatch liver transplant (T cell flow crossmatch or B cell flow crossmatch). Exclusion Criteria: - Adult ( = = 18 years) renal transplant recipient.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Liver Transplant
Patients will obtain a research blood draw and a liver biopsy at 4 months and 12 months post transplant. Liver biopsies are routinely performed in the liver transplant population. We will be obtaining a liver biopsy at this particular time point to compare the biopsy results with the peripheral blood results.

Locations

Country Name City State
United States Mayo Clinic Jacksonville Florida
United States Mayo Clinic Phoenix Arizona
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results. The primary endpoint for this study is defined as obtaining the results of the RNAseq testing and to determine if an assay for rejection can be developed. 3 years
Secondary To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results. The secondary endpoint for this study is defined as obtaining the results of the RNAseq testing and to ascertain whether an assay for detection of disease recurrence can be developed. 3 years
See also
  Status Clinical Trial Phase
Completed NCT01678937 - Immune Tolerance and Alloreactivity in Liver Transplant Recipients on Different Monotherapy Immunosuppressive Agents N/A
Completed NCT03781414 - Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension Phase 2
Recruiting NCT02260375 - MSC Therapy in Liver Transplantation Phase 1
Not yet recruiting NCT04514666 - VOCs in Kidney and Liver Transplants N/A
Not yet recruiting NCT05335551 - TRU-IMMUNO: Optimizing Liver Immunosuppression
Completed NCT01745731 - Cell Infusion Intraportal Autologous Bone Marrow Mononuclear as Enhancer of Liver Regeneration Phase 2
Enrolling by invitation NCT05082077 - Global Utilization And Registry Database for Improved preservAtion of doNor Livers
Completed NCT06060808 - Role of NFKBIA and PTPN22 Genes Polymorphism in Acute Rejection Susceptibility After Living Donor Liver Transplantation in Egyptian Patients.
Completed NCT04789213 - Mortality, Morbidity and Risk Factors of Liver Retransplantation
Recruiting NCT06400771 - Safety of DNP007 in Healthy Subjects Phase 1
Recruiting NCT03603548 - Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial N/A
Withdrawn NCT03315052 - Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects Phase 4
Enrolling by invitation NCT05655273 - Conversion of Maintenance Prograf to Envarsus in Liver Transplant Recipients Phase 4
Active, not recruiting NCT05325073 - Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients Phase 4
Recruiting NCT05707520 - Long-term Benefit of MPA in Liver Transplantation
Recruiting NCT04657562 - The New LC-MS/MS Method for Determination of Unbound Tacrolimus in Plasma
Completed NCT01444079 - Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation N/A
Active, not recruiting NCT06153641 - Cytokeratin 18 Non-invasive Biomarker for Rejection in Liver Transplant Patients

External Links