STAART: Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AlloSure Assay prediction of Anti-body Mediated Rejection Determine whether AlloSure predicts the incidence of active, chronic Anti-body Mediated Rejection and cellular rejection in high risk patients |
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.
Diagnostic Test: 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.
|
Outcome Measures
Primary Outcome Measures
- AlloSure value change [post-operation day 1 and four. Pos-operation months 1, 2, 3,4,5,6]
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.
- PAXGene, [1 PAXgene tube will be collected 3 months post operation]
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
- PAXGene [1 PAXgene tube will be collected one year post operation]
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
Secondary Outcome Measures
- Exploring the association between Cytochrome P450 (CYP) expression and Donor-Derived Cell-Free DNA (dd-cfDNA) [post-operation day 1]
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.
- Exploring the association between CYP expression and dd-cfDNA [post-operation day 4]
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.
- Exploring the association between CYP expression and dd-cfDNA [post-operation month 1]
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.
- Exploring the association between CYP expression and dd-cfDNA [post-operation month 2]
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.
- Exploring the association between CYP expression and dd-cfDNA [post-operation month 3]
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.
- Exploring the association between CYP expression and dd-cfDNA [post-operation month 4]
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.
- Exploring the association between CYP expression and dd-cfDNA [post-operation month 5]
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.
- Exploring the association between CYP expression and dd-cfDNA [post-operation month 6]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult 18-80 year old
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Kidney transplant recipients (de novo or re-transplant, from living or deceased donor)
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BMI over 30
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Recipients with pre formed human leukocyte antigens (HLA) antibodies
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Recipients with donor specific antibodies
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Recipients who have undergone blood type incompatible transplantation (ABO incompatible)
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Recipients who have had prior kidney transplants.
Exclusion Criteria:
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Multi-Visceral transplant (simultaneous kidney pancreas, liver kidney, heart kidney)
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Contraindication to renal biopsy
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Refusing biopsy
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Kidney transplant recipient that is a monozygotic twin to the donor
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | George Washington University | Washington | District of Columbia | United States | 20037 |
Sponsors and Collaborators
- George Washington University
- CareDx
- VirginiaBio Analytics, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCR191914