Kidney Transplant; Complications, Kidney Transplant Failure, Kidney Transplant Rejection
Conditions
Brief summary
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
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.
Interventions
PROCEDUREBlood Draw
Participants will have blood drawn for analysis at baseline and every 4 weeks for a total of 7 blood draws over 24 weeks.
Sponsors
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cPRA Concentrations | 1 day | Outcome is reported as the serum concentration of calculated Panel Reactive Antibody (cPRA) at baseline. |
| cf-DNA Concentrations | up to 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ESA Dose | 24 weeks | Outcome is reported as the percent of participants who require a erythropoesis stimulating agent (ESA) dose. |
| Incidence of Need for Transfusion | 24 weeks | Outcome is reported as the percent of participants who require transfusion. |
| Incidence of Gross Hematuria | 24 weeks | Outcome is reported as the percent of participants who experience gross hematuria. |
| Incidence of Allograft Tenderness | 24 weeks | Outcome is reported as the percent of participants who experience allograft tenderness. |
| Incidence of Need for Methylprednisolone and Allograft Nephrectomy | 24 weeks | Outcome is reported as the percent of participants who require methylprednisolone and allograft nephrectomy |
Countries
United States
Outcome results
None listed