Kidney Transplant Rejection Clinical Trial
Official title:
The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
The ProActive registry is a longitudinal, multi-center study with a prospective arm observing clinical care for patients receiving physician ordered Prospera, an allograft rejection test, and a historical control arm collecting data on cases at the same sites whose kidney allograft rejection status was managed with Serum Creatinine SCr/estimated Glomerular Filtration Rate eGFR. This registry will compare patient management and outcomes in patients who receive Prospera (Prospera arm) to the outcomes of the historical control group (control arm) to determine Prospera's clinical utility. High-risk subjects defined as having a biopsy-demonstrated rejection event or at least one pre-existing Donor Specific Antibody DSA with total Mean Fluorescent Intensity MFI>3000 or a calculated Panel Reactive Antibodies cPRA>70% will be followed for an additional period up to 24 months in both the Prospera arm and historical control arm.
The primary objective is to differentiate the clinical utility of Prospera testing from the use of creatinine testing as measured by the proportion of positive biopsies in post renal allograft patients. Secondary objectives include: - To observe the performance of the Prospera assay in detecting AR (repeated validation) - To evaluate whether Prospera can detect AR earlier and more often than SCr - To determine whether use of Prospera will significant decrease the rate of overall number of biopsies when compared to the rate of biopsies in the control arm ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04491552 -
TruGraf® Long-term Clinical Outcomes Study
|
||
| Withdrawn |
NCT04560582 -
Immunosuppression Reduction in Failed Allograft Guided by cfDNA
|
||
| Completed |
NCT05747274 -
SRDK0921_ Analytical Performance Study
|
||
| Not yet recruiting |
NCT05482100 -
CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
|
||
| Recruiting |
NCT06243289 -
Improving KIdney Transplantation With Cellular Therapy Study
|
||
| Not yet recruiting |
NCT06025240 -
Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
|
||
| Completed |
NCT04367610 -
Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection
|
||
| Enrolling by invitation |
NCT06126380 -
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
|
Phase 2 | |
| Terminated |
NCT05747053 -
Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
|
||
| Active, not recruiting |
NCT03714113 -
Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients
|
N/A | |
| Recruiting |
NCT05335538 -
TruGraf and TRAC In Pediatrics Study
|
||
| Completed |
NCT03663335 -
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
|
Phase 2 | |
| Completed |
NCT03652402 -
Precision Risk Stratification in Kidney Transplant Patients - EU-TRAIN
|
||
| Recruiting |
NCT04773392 -
Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR
|
Phase 4 | |
| Terminated |
NCT02974686 -
Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation
|
Phase 4 | |
| Completed |
NCT03873623 -
The TOGETHER Project - Kidney
|
||
| Terminated |
NCT04156204 -
Immunosuppressant Medication Dosed Daily After Kidney Transplant
|
Early Phase 1 | |
| Completed |
NCT04601155 -
Transition of Renal Patients Using AlloSure Into Community Kidney Care
|
||
| Completed |
NCT03874299 -
The TOGETHER Project - Kidney RNA-seq Validation
|
||
| Completed |
NCT03965559 -
The Efficacy of Plasmapheresis and Double Filtration Plasmapheresis (DFPP) in Kidney Transplant
|