Allosure in Simultaneous Pancreas Kidney Transplant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-26

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will observe donor derived cell free DNA percentages (via the Allosure test) in combined kidney-pancreas transplant recipients to establish both stable and dysfunctional Allosure assay levels

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessing Benchmarks For Allosure And Allomap Testing in Simultaneous Kidney & Pancreas Transplant Recipients.

NCT04855422

Transplant; Complication, Rejection

RECRUITING

Eliminating the Need for Pancreas Biopsy Using Peripheral Blood Cell-free DNA

NCT04166149

Transplant;Failure,Kidney Transplant; Failure, Pancreas Rejection Acute Renal +1 more

COMPLETED

Donor-Derived Cell-Free DNA for Surveillance in Simultaneous Pancreas and Kidney Transplant Recipients

NCT04130685

Pancreas Transplant Rejection Kidney Transplant Rejection

COMPLETED

Donor-derived Cell-free DNA in Kidney Transplant Recipients

NCT06476717

Kidney Transplantation Acute Rejection of Renal Transplant

COMPLETED

Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation

NCT02424227

Kidney Transplant Recipients

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Simultaneous kidney-pancreas transplantation is the optimal treatment for select patients with type 1 diabetes and kidney failure. Limited biomarkers are utilized to monitor the health of the allografts. For kidney transplantation serum creatinine remains the most commonly monitored biomarker; for the pancreas allograft blood glucose and serum amylase and lipase are measured. However, these biomarkers are imprecise and non-specific for rejection.

In kidney transplantation cell free donor derived DNA at of value of \>1% has emerged as an effective immune monitoring tool as a marker for renal allograft rejection and injury. Thus far, a discriminatory donor derived cell free DNA value for a stable and rejecting allografts has not been established for recipients of combined kidney-pancreas transplants.

Study aim will be to help establish a normal range of donor derived cell free DNA in stable kidney-pancreas graft function in combined kidney pancreas transplant recipients while determining changes in cell free DNA in kidney-pancreas recipients with biopsy proven allograft rejection.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Pancreas Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

WU/Barnes cohort

SPK patients in this group will be recruited from WU/Barnes Transplant center. A total of 25 from this cohort will be recruited and asked to provide a blood sample to test for donor derived cell free DNA 3 times over the course of the first year of transplant. In addition, if any biopsies or rejections occur, additional samples will be requested at the time of biopsy and for an additional two follow-ups at least one month apart.

DD-cfDNA

Intervention Type OTHER

We are obtaining samples for donor derived cell free DNA in an observational manner. There is no intervention in this study

UT Southwestern cohort

SPK patients in this group will be recruited from WU/Barnes Transplant center. A total of 25 from this cohort will be recruited and asked to provide a blood sample to test for donor derived cell free DNA 3 times over the course of the first year of transplant. In addition, if any biopsies or rejections occur, additional samples will be requested at the time of biopsy and for an additional two follow-ups at least one month apart.

DD-cfDNA

Intervention Type OTHER

We are obtaining samples for donor derived cell free DNA in an observational manner. There is no intervention in this study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DD-cfDNA

We are obtaining samples for donor derived cell free DNA in an observational manner. There is no intervention in this study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥18 years
* Kidney-pancreas transplant recipients
* Patient must have stable creatine, lipase, amylase for at least a two month span after transplant OR patient must receive a biopsy within one year post transplant