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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidney Transplant Patients with Failed Allograft | All participants are assigned to a single cohort of kidney transplant patients with failed allograft requiring dialysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Draw | Procedure | Participants will have blood drawn for analysis at baseline and every 4 weeks for a total of 7 blood draws over 24 weeks. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This study proposes to recruit adult patients primarily from the inpatient units at UMMC Fairview, or the Renal or Transplant facilities at the Clinics and Surgery Center as attended by the PI and Co-Is. Additional clinics will be recruited from depending on patient population and clinician support.
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| Name | Affiliation | Role |
|---|---|---|
| Adam Bregman, MD | University of Minenesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Specimens will be stored by study code. All study data will be associated with the specimen through the study code link.
| 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 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |