Protocol Number: 04-DK-0193

Title:

Identification and Mechanistic Investigations of Tolerant Kidney Transplant Patients

Number:

04-DK-0193

Summary:

This study will investigate tolerance in kidney transplant patients. One of the most common complications of kidney transplantation is organ rejection, which occurs because the body's immune system tries to attack (reject) the newly transplanted kidney. To prevent this, patients are given immunosuppressive, or anti-rejection, drugs. Most patients who stop taking these drugs reject their transplanted kidney; however, some patients do not reject the transplanted kidney and it continues to work well. These patients are said to "tolerate" the transplanted kidney, and this condition is referred to as tolerance. This study will establish a database of clinical and laboratory information that may help to identify unique characteristics of tolerant patients.

Patients 18 years of age and older who have had a kidney transplant and people who donated their kidneys for these patients may be eligible for this study. Patients are divided into 6 groups, according to the medicines they are currently taking and the status of their kidney function. A seventh group comprises patients who received a kidney from an identical twin, and an eighth group comprises kidney donors. Patients are screened with a medical history and a skin test to determine how well their immune system responds to foreign substances.

Patients in group 1 (patients who have stopped taking immunosuppressive medications for at least 1 year and whose transplanted kidney functions in a normal and stable manner) are required only to undergo the screening assessment, but may choose to participate in the following procedures, which are required for groups 2-7:

-Baseline visit - Review of medical history and demographic information; routine blood tests; 24-hour urine sample; blood draw by standard method (phlebotomy) or by leukapheresis for tolerance tests. For leukapheresis, a needle is placed in a vein in each arm. Blood is collected from one arm and directed to a machine that separates it into its components. Some of the white blood cells are removed, and the rest of the blood is returned to the patient through the needle in the other arm.

-Visits 1-6 (months 6, 12, 18, 24, and 36) - Review of medical history, including status of transplanted kidney; blood and urine samples for routine laboratory tests. If kidney function declines during the course of the study, patients will be asked to provide: additional blood and urine samples for routine laboratory tests; a 24-hour urine sample; and blood for tolerance tests, collected by standard phlebotomy or leukapheresis.

Patients in all groups may be asked to provide a biopsy sample of their transplanted kidney for tolerance assays and for microscopic examination. The biopsy may be repeated if kidney function worsens. For this procedure, a small piece of the transplanted kidney is removed with a special needle. Biopsies are an optional procedure.

Kidney donors provide blood samples for tolerance assays. They may be asked to provide additional samples if the kidney they donated deteriorates in function. The donor may choose to provide the blood sample by leukapheresis or by phlebotomy.

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): Children

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):

Tolerance

Renal

Allograft

Rejection

Immunosuppression

Recruitment Keyword(s):

Kidney Transplant

Condition(s):

Immune System Diseases

Graft Rejection

Kidney Transplantation

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

None

Supporting Site:

National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Allergy and Infectious 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):

Benfield MR, Herrin J, Feld L, Rose S, Stablein D, Tejani A. Safety of kidney biopsy in pediatric transplantation: a report of the Controlled Clinical Trials in Pediatric Transplantation Trial of Induction Therapy Study Group. Transplantation. 1999 Feb 27;67(4):544-7.

Hergesell O, Felten H, Andrassy K, Kuhn K, Ritz E. Safety of ultrasound-guided percutaneous renal biopsy-retrospective analysis of 1090 consecutive cases. Nephrol Dial Transplant. 1998 Apr;13(4):975-7.

Heeger PS, Greenspan NS, Kuhlenschmidt S, Dejelo C, Hricik DE, Schulak JA, Tary-Lehmann M. Pretransplant frequency of donor-specific, IFN-gamma-producing lymphocytes is a manifestation of immunologic memory and correlates with the risk of posttransplant rejection episodes. J Immunol. 1999 Aug 15;163(4):2267-75.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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