Immunosuppression Clinical Trial
Official title:
Renal Transplantation With Immune Monitoring
The aim of this observational study is to evaluate an FDA approved immune system monitoring assay (Immunknow, Cylex Inc. Columbia, MD) in renal transplant recipients using standard immunosuppression and prophylaxis protocols from the time of transplantation through a twelve month follow-up period. The primary endpoint will be the incidence of acute rejection and infection and any correlation of these events to an assay that may be a measure of recipient immune response. Secondary endpoints will include evaluation of renal function, patient and graft survival, incidence of post-transplantation lymphoproliferative disorder and duration and extent of lymphocyte depletion.
As compared to previous eras, renal transplantation is a procedure associated with low acute
rejection rates and excellent one year graft survival. Despite this success, long term graft
survival rates have not improved significantly. The reasons for late graft loss are
multi-factorial, but include chronic rejection and infection. Thus, avoidance of chronic
over immunosuppression is tantamount in avoiding graft or patient threatening infection,
while avoidance of under immunosuppression is necessary to prevent graft loss from acute or
chronic rejection. Renal allograft loss from a particular viral pathogen, BK virus, has
become evident in the era of modern immunosuppression and likely reflects relative over
immunosuppression. We, and others, have used BK detection as an imprecise marker of over
immunosuppression to help guide adjustments in chronic immunosuppressive therapy. While
screening for the presence of BK virus is helpful in avoiding over immunosuppression and
potential graft loss from BK nephropathy, a correlate assay is not readily available that
provides evidence of under immunosuppression, indicating risk of graft loss from rejection.
At present, a proven assay to measure the strength of the immune system is unavailable, and
the only definite markers of over or under-immunosuppression remain infection and rejection,
respectively. A tool to help tailor chronic immunosuppressive therapy and decrease the
incidence of either of these two extremes would be of significant value in helping to
prolong allograft survival and decrease the risk of immunosuppressive therapy in renal
transplant recipients.
In this observational study, we plan to use a standard immunosuppressive regimen as well as
standard infection prophylaxis with the addition of an immune monitoring assay (ImmunoKnow).
This assay measures ATP production by recipient T cells and has been proposed as a marker of
immune function. While of interest, there are as yet, no published studies describing the
utility of this test for immune monitoring in adult renal transplant recipients. As this
assay remains unproven as a viable tool to define over or under immunosuppression, we will
be blinded to the ImmunoKnow results during the course of the study. The results from the
immune monitoring assay will only be used in a retrospective analysis to determine if there
is any clinically relevant correlation between the values obtained and episodes of
rejection, infection, or the development of donor specific antibodies. If a significant
correlation is suggested, further evaluation in subsequent studies and eventual
incorporation into prospective patient care may be warranted.
;
Observational Model: Case-Only, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06026592 -
Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
|
||
Active, not recruiting |
NCT02444429 -
3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation
|
Phase 3 | |
Completed |
NCT02238418 -
Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria.
|
Phase 4 | |
Completed |
NCT01729494 -
Belatacept Early Steroid Withdrawal Trial
|
Phase 4 | |
Terminated |
NCT01436305 -
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
|
Phase 2 | |
Completed |
NCT02843295 -
Catalytic Antibodies to Predict Uninvasively Late Transplant Failure
|
N/A | |
Terminated |
NCT01276834 -
Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation
|
Phase 4 | |
Completed |
NCT00842699 -
Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab
|
N/A | |
Completed |
NCT00525681 -
Interaction Between Rimonabant and Cyclosporine and Tacrolimus
|
Phase 4 | |
Completed |
NCT00776750 -
Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients
|
Phase 4 | |
Completed |
NCT00189735 -
A Study to Evaluate FK778 in Kidney Transplant Patients
|
Phase 2 | |
Recruiting |
NCT04052867 -
Intravenous Lignocaine Infusion in Laparoscopic Donor Nephrectomy
|
N/A | |
Recruiting |
NCT03114826 -
Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients
|
N/A | |
Completed |
NCT02587052 -
A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac
|
||
Completed |
NCT02020642 -
Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)
|
N/A | |
Completed |
NCT01435291 -
AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation
|
Phase 4 | |
Recruiting |
NCT01001065 -
Association of the Intrarenal Resistance Index (RI) of Transplanted Kidneys With Generalized Atherosclerosis
|
N/A | |
Completed |
NCT00978965 -
Identification of Patients With High Probability of Poorly Responding to Therapy With Mycophenolic Acid Prodrugs
|
||
Recruiting |
NCT00903188 -
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
|
Phase 4 | |
Completed |
NCT00400400 -
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
|
Phase 4 |