Trials / Terminated
TerminatedNCT05747053
Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
Surveillance Testing Utilizing AlloSure to Assess Rejection Following Transplantation and Personalization of Immunosuppressive Therapy
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 105 (actual)
- Sponsor
- George Washington University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Kidney Injury
- Kidney Failure
- Kidney Failure, Chronic
- Kidney Failure, Acute
- Kidney Diseases
- Kidney Transplant Rejection
- Kidney Transplant Infection
- Kidney Transplant; Complications
- Kidney Disease, Chronic
- Kidney Ischemia
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-10-01
- Primary completion
- 2022-12-08
- Completion
- 2022-12-08
- First posted
- 2023-02-28
- Last updated
- 2024-02-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05747053. Inclusion in this directory is not an endorsement.