Kidney Transplantation Clinical Trial
Official title:
The Pathogenesis of Chronic Graft Failure After Kidney Transplantation
Verified date | June 17, 2014 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will examine whether measurements of connective tissue growth factor (CTGF) and
other cell proteins can identify which kidney transplant recipients are likely to develop
chronic allograft nephropathy (CAN), a disease of the transplanted kidney. CAN may occur
months to years after the transplant. The kidney becomes progressively scarred and eventually
loses all function, so that dialysis or another transplant is needed. A better understanding
of how CTGF and other proteins are involved in the development of CAN may provide new targets
for treating for the disease.
Patients who are scheduled to receive a kidney or combined kidney-pancreas transplant or who
have received a transplant recently (within 6 months) may be eligible for this study.
Participants will be enrolled before the transplant, if possible, or after the transplant,
and will undergo the following tests and procedures:
- Physical examinations at the screening visit, at 1, 6, 12, and 24 months, and then once
yearly.
- Blood sample collections at the screening visit, at 1, 6, 12, 18, and 24 months and then
once yearly.
- Urine sample collections at the screening visit, at 1, 6, 12, 18, and 24 months and then
once yearly.
- Kidney biopsies at the beginning of the study, at 1, 6, 12, and 24 months, and then once
a year for research purposes. Participants may refuse to have a research biopsy at any
time during the study. Also, patients who are having a kidney biopsy for another reason
at these time points will not have a second biopsy. The biopsy procedure takes about 15
minutes and is done in the hospital. The patient lies on his or her back and the skin
over the transplanted kidney is cleaned with alcohol and iodine. The area is numbed with
an injection of an anesthetic, and then a biopsy needle is placed through the kin. The
biopsy may be repeated up to three times to get enough tissue to test for CAN. Patients
lie flat for 4 hours after the procedure to reduce the risk of bleeding, and are
observed for another 2 hours for possible complications.
Status | Completed |
Enrollment | 134 |
Est. completion date | June 17, 2014 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years and older |
Eligibility |
- INCLUSION CRITERIA: Recipients of living related, living unrelated, and cadaveric kidney transplants. This study will be open to all patients currently enrolled in NIDDK transplant protocols as well as patients recruited from other transplant centers. Ability and willingness to provide informed consent (adults greater than or equal to 18.0 years) or assent (children 4 to 18.0 years). EXCLUSION CRITERIA: Inability to provide informed consent. Inability to return to NIH for follow-up. Inability or unwillingness to release outside medical records or pathology. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Cecka JM. The UNOS renal transplant registry. Clin Transpl. 2001:1-18. — View Citation
Hariharan S, Johnson CP, Bresnahan BA, Taranto SE, McIntosh MJ, Stablein D. Improved graft survival after renal transplantation in the United States, 1988 to 1996. N Engl J Med. 2000 Mar 2;342(9):605-12. — View Citation
Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, Held PJ, Port FK. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999 Dec 2;341(23):1725-30. — View Citation
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 | |
Terminated |
NCT01436305 -
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
|
Phase 2 | |
Completed |
NCT01672957 -
ORANGE Study: An Observational Study on Renal Function in Kidney Transplant Patients on Immunosuppressive Therapy Containing CellCept (Mycophenolate Mofetil)
|
N/A |