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Protocol Number:
03-DK-0132
- Title:
The Pathogenesis of Chronic Graft Failure after Kidney Transplantation
- Number:
03-DK-0132
- Summary:
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.
- Sponsoring Institute:
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Recruitment Detail
- Type:
Completed Study; data analyses ongoing
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
None
- Eligibility Criteria:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Special Instructions:
Currently Not Provided
- Keyword(s):
-
TGF-Beta
-
Kidney
-
Transplantation
-
Rejection
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Immunosuppression
- Recruitment Keyword(s):
-
Kidney Transplant
-
Chronic Allograft Nephropathy
-
CAN
- Condition(s):
-
Kidney Transplantation
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Interventions:
- None
- Supporting Site:
-
National Institute of Diabetes and Digestive and Kidney Diseases
- Contact(s):
-
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Citation(s):
-
Wolfe RA, et al., 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.
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Hariharan S, et al. Improved graft survival after renal transplantation in the United States, 1988 to 1996. N Engl J Med. 2000 Mar 2;342(9):605-12.
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Cecka JM. The UNOS renal transplant registry. Clin Transpl. 2001;:1-18.
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