Personalization of Immunosuppressive Treatment for Organ Transplant Recipients

Kidney Diseases Clinical Trial

— STAART  

Official title:

Surveillance Testing Utilizing AlloSure to Assess Rejection Following Transplantation and Personalization of Immunosuppressive Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05747053
• Other study ID #: NCR191914
• Status: Terminated
• Start date: October 1, 2020
• Est. completion date: December 8, 2022

Study information

• Verified date: February 2024
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Long-term graft failure rates continue to be unacceptably high despite the development of immunosuppressive drugs, underscoring the unmet need for robust prognostic biomarkers of allograft injury and failure. While rates of acute rejection (AR) continue to decrease, it remains the strongest predictor of long-term allograft survival, and so having a better understanding of factors predicting AR may contribute to more individualized patient care. Selecting optimum immunosuppressive dosage is another factor in personalizing kidney care. This project will study two areas of individualized kidney care: 1) assessing rejection by surveillance testing utilizing AlloSure, 2) developing an algorithm to select optimum immunosuppressive medication dosage.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: December 8, 2022
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult 18-80 year old

• Kidney transplant recipients (de novo or re-transplant, from living or deceased donor)

• BMI over 30

• Recipients with pre formed human leukocyte antigens (HLA) antibodies

• Recipients with donor specific antibodies

• Recipients who have undergone blood type incompatible transplantation (ABO incompatible)

• Recipients who have had prior kidney transplants.

Exclusion Criteria:

• Multi-Visceral transplant (simultaneous kidney pancreas, liver kidney, heart kidney)

• Contraindication to renal biopsy

• Refusing biopsy

• Kidney transplant recipient that is a monozygotic twin to the donor

• When more than two genomes may be present in the recipient plasma (more than recipient + donor): pregnancy, multiple-organ transplants from different donors (kidney after heart, kidney after liver transplant etc.), recipients of allogeneic blood or bone marrow transplant who have received cells with a genome different from the recipient (e.g. non-monozygotic twin)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Ischemia
• Kidney Disease, Chronic
• Kidney Diseases
• Kidney Failure
• Kidney Failure, Acute
• Kidney Failure, Chronic
• Kidney Injury
• Kidney Ischemia
• Kidney Transplant Infection
• Kidney Transplant Rejection
• Kidney Transplant; Complications
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• AlloSure
AlloSure blood-draw at Post-operation day one and four, as well as one month, 2 months, 3, 9, 12, 15,18 and 24 months operation.
• PAXGene
1 PAXgene tube will be collected with every biopsy performed and sent with the AlloSure test for the second 100 patients (patients 101-200). 21 gene markers will be sequenced by collecting 3 ml of blood.

Locations

Country	Name	City	State
United States	George Washington University	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
George Washington University	CareDx, VirginiaBio Analytics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AlloSure value change	Examine if AlloSure predicts the incidence of active, chronic Active antibody mediated rejection (cAMR) and cellular rejection in high risk patients. This will be assessed through observing the changes in AlloSure values one draw after another.	post-operation day 1 and four. Pos-operation months 1, 2, 3,4,5,6
Primary	PAXGene,	The test will be used to develop an algorithm to personalize immunosuppressive medication intake.	1 PAXgene tube will be collected 3 months post operation
Primary	PAXGene	The test will be used to develop an algorithm to personalize immunosuppressive medication intake.	1 PAXgene tube will be collected one year post operation
Secondary	Exploring the association between Cytochrome P450 (CYP) expression and Donor-Derived Cell-Free DNA (dd-cfDNA)	Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that AlloSure will correlate with increased CYP expression.	post-operation day 1
Secondary	Exploring the association between CYP expression and dd-cfDNA	Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.	post-operation day 4
Secondary	Exploring the association between CYP expression and dd-cfDNA	Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.	post-operation month 1
Secondary	Exploring the association between CYP expression and dd-cfDNA	Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.	post-operation month 2
Secondary	Exploring the association between CYP expression and dd-cfDNA	Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.	post-operation month 3
Secondary	Exploring the association between CYP expression and dd-cfDNA	Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.	post-operation month 4
Secondary	Exploring the association between CYP expression and dd-cfDNA	Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.	post-operation month 5
Secondary	Exploring the association between CYP expression and dd-cfDNA	Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.	post-operation month 6