Kidney Transplantation Clinical Trial
Official title:
Correlation of Donor Proinflammatory mRNA Profiles With Early Outcomes of Thoracic and Abdominal Transplantation
Activity of genes in donor tissues that are involved in inflammation are thought to be involved with early organ dysfunction, increased immune responses in transplant recipients, and organ rejection. The purpose of this study is to determine the relationship between genetic expression in donor and recipient tissue with transplant survival. Participants in this study will have received heart, lung, liver, or kidney transplants.
Inflammation and injuries to transplanted organs during the immediate post-operative period
may be linked to early organ dysfunction and higher rates of transplant rejection in the
recipient. Currently, mRNA expression of proinflammatory genes in donor tissues is thought
to be a risk factor for early organ transplant dysfunction, increased expression of the
recipients cell-mediated immunity genes, and organ rejection. The purpose of this study is
to test the association between proinflammatory mRNA expression in donor samples and
subsequent development of early organ dysfunction in kidney, lung, and liver transplant
recipients. This study will also test the effects of proinflammatory mediators expressed in
the transplanted organ pre- and post-reperfusion on organ rejection and genes expressed in
cell mediated immune responses. This will be achieved by identifying the proinflammatory
immune responses and their mechanisms.
This study will consist of up to 11 study visits over a period of 2 years. The baseline
visit will occur 24 hours prior to organ transplantation. Follow-up visits will occur daily
for Days 1 to 3 (for lung transplant recipients only) and on Day 7, Week 6, and Months 3, 6,
9, 12, 18, and 24 post-transplant. At the baseline visit, a physical exam, medical history,
demographics, vital signs measurements, blood collection, and collection of donor tissue
sample will occur. For most or all other study visits, medication and adverse events
tracking and blood collection will occur. Depending on the transplant type, participants
will undergo the following procedures:
- Heart: Participants will undergo a heart biopsy that is part of standard clinical care
following a heart transplant. An echocardiogram and an electrocardiogram will occur at
most visits.
- Kidney: Renal biopsies will be performed 1 hour after reperfusion at the time of
surgery. Urine collection will occur at most visits.
- Liver: Liver biopsies will be performed at the time of procurement and within 1 hour of
reperfusion.
- Lung: Participants will undergo bronchoalveolar lavage that is part of standard
clinical care following a lung transplant. A chest x-ray, an arterial blood gas test, a
pulmonary function test, and 6-minute walking test will occur at some visits.
;
Observational Model: Case-Only, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04910867 -
APOL1 Genetic Testing Program for Living Donors
|
N/A | |
Completed |
NCT02723591 -
To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients
|
Phase 4 | |
Completed |
NCT05945511 -
Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?
|
||
Completed |
NCT02234349 -
Bile Acids and Incretins in Pancreas Kidney Transplant Patients
|
N/A | |
Completed |
NCT04496401 -
PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus
|
Phase 4 | |
Recruiting |
NCT05917795 -
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
|
N/A | |
Not yet recruiting |
NCT05934383 -
Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension
|
N/A | |
Withdrawn |
NCT04936971 -
Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response
|
Phase 4 | |
Not yet recruiting |
NCT04540640 -
Oxygenated Machine Preservation in Kidney Transplantation
|
N/A | |
Not yet recruiting |
NCT03090828 -
Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease
|
N/A | |
Recruiting |
NCT02908139 -
Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients
|
N/A | |
Completed |
NCT02560558 -
Bela 8 Week Dosing
|
Phase 4 | |
Terminated |
NCT02417870 -
Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation
|
Phase 1/Phase 2 | |
Recruiting |
NCT02154815 -
Pre-emptive Kidney Transplantation Quality of Life
|
N/A | |
Completed |
NCT02235571 -
iChoose Decision Kidney Aid for End-Stage Renal Disease Patients
|
N/A | |
Enrolling by invitation |
NCT01905514 -
ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients
|
N/A | |
Completed |
NCT02147210 -
Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1
|
N/A | |
Recruiting |
NCT01699360 -
The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients
|
Phase 4 | |
Completed |
NCT01672957 -
ORANGE Study: An Observational Study on Renal Function in Kidney Transplant Patients on Immunosuppressive Therapy Containing CellCept (Mycophenolate Mofetil)
|
N/A | |
Terminated |
NCT01436305 -
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
|
Phase 2 |