Immunosuppression Reduction in Failed Allograft Guided by cfDNA

Study Overview
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Brief Summary
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The optimal timing for immunosuppression tapering for patients with failed kidney transplant is not known. This pilot study would be to correlate rise in cf-DNA and increase in cPRA.

Detailed Description
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This is an observational cohort study collecting data and blood specimens at designated time points. The primary outcome will be comparing the cPRA in patients that have a rise in cf-DNA to those that do not have a rise in cf-DNA. Seondary outcomes include comparison of the combined incidence of need for transfusion, need for methylprednisolone and allograft nephrectomy, ESA dose, allograft tenderness, and gross hematuria.

Official Title
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Immunosuppression Reduction in Failed Allograft Guided by cfDNA

Conditions
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Kidney Transplant; Complications, Kidney Transplant Rejection, Kidney Transplant Failure

Intervention / Treatment
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* Procedure: Blood Draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Failed allograft requiring dialysis No living donor available for re-transplant option or anticipated deceased donor within the next 12 months Patient to be enrolled prior to 3rd HD (hemodialysis) session or within 1 week of starting peritoneal dialysis Exclusion Criteria: 17 years or younger cPRA at entrance of 100% Primary non-function of the allograft Multi-organ transplant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney Transplant Patients with Failed Allograft<br>All participants are assigned to a single cohort of kidney transplant patients with failed allograft requiring dialysis. | Procedure: Blood Draw<br>* Participants will have blood drawn for analysis at baseline and every 4 weeks for a total of 7 blood draws over 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cPRA Concentrations | Outcome is reported as the serum concentration of calculated Panel Reactive Antibody (cPRA) at baseline. | 1 day | 
| cf-DNA Concentrations | Outcome is reported as the serum concentration of circulating-free DNA (cfDNA) at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks. | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Need for Transfusion | Outcome is reported as the percent of participants who require transfusion. | 24 weeks | 
| Incidence of Need for Methylprednisolone and Allograft Nephrectomy | Outcome is reported as the percent of participants who require methylprednisolone and allograft nephrectomy | 24 weeks | 
| Incidence of ESA Dose | Outcome is reported as the percent of participants who require a erythropoesis stimulating agent (ESA) dose. | 24 weeks | 
| Incidence of Allograft Tenderness | Outcome is reported as the percent of participants who experience allograft tenderness. | 24 weeks | 
| Incidence of Gross Hematuria | Outcome is reported as the percent of participants who experience gross hematuria. | 24 weeks |