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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

This is a non-randomized, non-interventional, prospective pilot cohort study to monitor SPK patients post-transplant to determine if non-invasive measures using dd-cfDNA (Allosure) and AlloMap can assess an array of immune panels to predict and confirm the development of allograft injury and rejection in either organ. Aims of the study 1. To develop and validate AlloSure and AlloMap in SPK transplant recipients with stable allograft function and in diagnosis of acute TCMR and ABMR in either organ 2. To assess the ability of AlloSure and AlloMap to determine early discordant rejection in SPK recipients 3. To investigate AlloSure and AlloMap in SPK transplant recipients with diagnosis of BKV viremia

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Participant is willing and able to give informed consent for participation in the study.

• Male or Female, aged 18 years or above.

• SKP transplant recipients between 1 month and 3 years after transplantation

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Enver Akalin, MD
eakalin@montefiore.org
877.287.3536
Backup
Maria Ajaimy, MD
majaimy@montefiore.org
(718) 920-4321
Time Frame
Start Date: 2021-07-14
Estimated Completion Date: 2026-12
Participants
Target number of participants: 50
Treatments
Stable SPK recipients without rejection and/or BKV viremia
All SPK transplant recipients are monitored for routine labs twice a week first month, weekly at 2nd and 3rd month, every 2 weeks between 3-6 months, once a month between 6-12 months and then once every 2 months.
Acute T-Cell Mediated Rejection (TCMR )
Kidney and pancreas transplant biopsies will be solely for clinically indicated for increased creatinine, amylase, lipase, blood sugar levels of more than 20% of the baseline, increased spot urine protein/creatinine ratio more than 1 gram/day, and development of donor-specific anti-HLA antibodies.
Antibody Medicated Rejection (ABMR)
Kidney and pancreas transplant biopsies will be solely for clinically indicated for increased creatinine, amylase, lipase, blood sugar levels of more than 20% of the baseline, increased spot urine protein/creatinine ratio more than 1 gram/day, and development of donor-specific anti-HLA antibodies.
BKV viremia
All patients will be monitored for BKV viremia monthly after transplantation up to 6 months and at 9, 12 and 24 months. Luminex SAB will be monitored at 1, 3, 12 and 24 months. Spot urine protein and creatinine and HbA1c will be monitored every 3 months after transplantation
Follow-up of subjects with acute TCMR, ABMR and BKV viremia after treatment
BKV viremia, Luminex SAB, spot urine protein and creatinine is studied at the time clinically indicated biopsy and/o worsening kidney function and proteinuria.
Sponsors
Collaborators: CareDx
Leads: Montefiore Medical Center

This content was sourced from clinicaltrials.gov