Allosure in Simultaneous Pancreas Kidney Transplant

Kidney Pancreas Transplant Clinical Trial

Official title:

Assessment of Donor Derived Cell-free DNA in Combined Kidney-pancreas Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04777617
• Other study ID #: 202011048
• Status: Recruiting
• Start date: February 26, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: Washington University School of Medicine
• Contact: Rowena Delos Santos
• Phone: 314-362-8351
• Email: delossantos[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Pancreas Transplant

Intervention

Other:
• DD-cfDNA
We are obtaining samples for donor derived cell free DNA in an observational manner. There is no intervention in this study

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	CareDx, University of Texas

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DD-cfDNA level	determine level of donor derived cell free DNA from SPK patients	1 year