Clinical trial NCT04777617: Allosure in Simultaneous Pancreas Kidney Transplant
Official title: Assessment of Donor Derived Cell-free DNA in Combined Kidney-pancreas Recipients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Pancreas Transplant
Keywords: Kidney pancreas transplant
Deceased donor cell free DNA
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: CareDx
name: University of Texas
First posted: 2021-03-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This population will be SPK patients with stable Cr, lipase and amylase for at least 2 months post transplant and enrolled within the first year after transplant

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Exclusion Criteria:

* Presence of non-renal or pancreas transplanted organ
* Patient is not enrolled within 1 year after transplant

Primary outcomes:
measure: DD-cfDNA level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University in Saint Louis School of Medicine
name: Rowena Delos Santos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bloom RD, Bromberg JS, Poggio ED, Bunnapradist S, Langone AJ, Sood P, Matas AJ, Mehta S, Mannon RB, Sharfuddin A, Fischbach B, Narayanan M, Jordan SC, Cohen D, Weir MR, Hiller D, Prasad P, Woodward RN, Grskovic M, Sninsky JJ, Yee JP, Brennan DC; Circulating Donor-Derived Cell-Free DNA in Blood for Diagnosing Active Rejection in Kidney Transplant Recipients (DART) Study Investigators. Cell-Free DNA and Active Rejection in Kidney Allografts. J Am Soc Nephrol. 2017 Jul;28(7):2221-2232. doi: 10.1681/ASN.2016091034. Epub 2017 Mar 9.
citation: Grskovic M, Hiller DJ, Eubank LA, Sninsky JJ, Christopherson C, Collins JP, Thompson K, Song M, Wang YS, Ross D, Nelles MJ, Yee JP, Wilber JC, Crespo-Leiro MG, Scott SL, Woodward RN. Validation of a Clinical-Grade Assay to Measure Donor-Derived Cell-Free DNA in Solid Organ Transplant Recipients. J Mol Diagn. 2016 Nov;18(6):890-902. doi: 10.1016/j.jmoldx.2016.07.003. Epub 2016 Oct 7.