Kidney Transplantation Clinical Trial
Official title:
Identification and Mechanistic Investigations of Tolerant Transplant Recipients
The purpose of this multi-center (observational) registry study is to establish a database of clinical and laboratory information that may help to identify any unique characteristics of tolerant participants that differ from participants who reject their kidney after discontinuing immunosuppressive drugs.
Following kidney (renal) transplantation, one possible complication is rejection of the new
kidney. This occurs as a results of the body's immune system attacking (or rejecting) the
newly transplanted kidney. After transplant, medicines known as "immunosuppressive" or
"anti-rejection" drugs are given to transplant recipients to help prevent rejection of the
transplanted kidney. If a transplant recipient stops taking these medicines, they almost
always reject their transplanted kidney. However, in some exceptionally rare instances,
transplant recipients who stop taking these drugs do not reject their kidney, and the kidney
keeps working. The recipients are said at that point to "tolerate" the transplanted kidney,
and this condition is referred to as "tolerance".
In this study, participants will be asked to provide consent for the collection of extensive
demographic and clinical information; medical histories; and blood and urine samples. Blood
and urine samples collected will be used to perform specific assays to help define
mechanisms of tolerance.
Originally the study included 11 groups as listed; however, at present only groups 1,4, and
8 remain active. Whereas the initial study duration was 6 years, this was extended to 11
years in order to follow over more extended time a B cell signature identified for tolerant
kidney subjects and how this signature may change. (Refer to publications section: Newell,
Kirk et al, J Clin Invest. 2010).
;
Observational Model: Cohort, 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 | |
| Terminated |
NCT02417870 -
Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation
|
Phase 1/Phase 2 | |
| Completed |
NCT02560558 -
Bela 8 Week Dosing
|
Phase 4 | |
| 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 | |
| Completed |
NCT01655563 -
Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation
|
Phase 2 |