Protocol Details

Sirolimus Monotherapy to Optimize Activation Induced Cell Death (AICD) in Renal Transplants Following Lymphocyte Depletion Induction with Thymoglobulin

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	00-DK-0196
Sponsoring Institute	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruitment Detail	Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: UNK Max Age: UNK
Referral Letter Required	No
Population Exclusion(s)	Children
Special Instructions	Currently Not Provided
Keywords	Renal Failure; Anti-rejection; Apoptosis; Polyclonal Antibody
Recruitment Keyword(s)	Kidney Transplant
Condition(s)	Kidney Failure
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	Drug: Sirolimus Drug: Thymoglobulin
Supporting Site	National Institute of Diabetes and Digestive and Kidney Diseases

This study will test the safety and effectiveness of two drugs, Sirolimus and Thymoglobulin, for preventing rejection of transplanted kidneys. Standard anti-rejection therapy uses a combination of drugs, such as cyclosporine, tacrolimus, azathioprine, steroids, and others, that are taken daily for life. However, even with this daily therapy, more than half of kidney recipients slowly reject their transplant within 10 years. Both Thymoglobulin, an antibody, and Sirolimus, an anti-rejection drug, prevent rejection by lowering the response of the immune system to the transplanted organ. Thymoglobulin is given in the pre- and postoperative period, and Sirolimus is taken long term.

Patients who receive a kidney transplant at the National Institutes of Health Clinical Center are eligible for this study. Candidates will be screened with a medical history, physical examination, and blood and urine tests.

Participants will undergo a kidney transplant. Before the surgery, a central line (intravenous catheter), through which blood and medicine can be given, is placed in the neck or chest. Patients may also undergo leukapheresis, a procedure for collecting white blood cells. The cells can be stored for transfusion later if white cell counts drop following Thymoglobulin treatment. For this procedure, blood is drawn from a needle placed in the arm and flows into a machine that separates the blood components by spinning. The white cells are collected in a bag and the red cells and plasma are returned through a second needle in the other arm.

Thymoglobulin will be given intravenously the day before the transplant and days 1 through 9 after the operation. Sirolimus will be taken by mouth, mixed with water or orange juice. Sirolimus therapy starts the day of the transplant and continues for life.

Follow-up study visits will be scheduled weekly for the first month after the transplant, then every 6 months for 1 year and then once a year for 4 years. Procedures during these visits may include blood and urine tests, physical examination, and check of vital signs (i.e., blood pressure, heart rate, breathing rate, temperature). Kidney biopsies (removal of a small piece of tissue for examination under the microscope) will be done at 2 weeks, 1 month and 6 months after surgery and then yearly for 4 years to check for any damage to the kidney. In addition, a local doctor will do routine laboratory tests 2 to 3 times a week for the first 2 to 3 months after transplantation, then weekly for several additional months, and at least monthly for life.

--Back to Top--

Eligibility

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.

--Back to Top--

Citations:

Half-life and risk factors for kidney transplant outcome- importance of death with function

Renal transplantation: a quarter century of achievement

Swanson SJ, Hale DA, Mannon RB, Kleiner DE, Chamberlain CE, Polly S, Harland DM, Kirk AD. Kidney transplantation with rabbit antithymocyte globulin induction and sirolimus monotherapy. The Lanset 360:1662-1664, 2002.

--Back to Top--

Contacts:

Principal Investigator	Referral Contact	For more information http://clinicalstudies.info.nih.gov.
Monique E. Cho, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health 10 Center Drive, MSC 1800 Building 10, Room 9C432A Bethesda, Maryland 20892-1800 (301) 496-1721 marcg@mail.nih.gov	Laura C. Wall National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health Building 10 Room 8E 10 Center Drive Bethesda, Maryland 20892 (301) 496-3531 erivera@cc.nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00006178

--Back to Top--

QUESTIONS?

Contact the Patient Recruitment and Public Liaison Office for:

• Details on how to participate in a study
• Details on how to refer a patient to a study

NIH Clinical Studies Information Request

---

Contact the Office of Communications for:

• General information about the NIH Clinical Center

www.cc.nih.gov/contact.shtml

---

Contact the Department Clinical Research Informatics, (DCRI) for:

• Technical questions about Adobe Acrobat and the PDF format
• Technical questions about this web server

webmaster@cc.nih.gov