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Live Donors for Kidney Transplants



Live Donors for Kidney Transplants

For Condition: Kidney Transplantation
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: On a yearly basis there are approximately 12,000 kidney transplants in the United States. Presently there are approximately 40,000 patients awaiting a transplant with only 5,000 available donors. Due to the obvious difference between organ supply and demand, live donors have become a standard source of kidneys for transplantation. Research has proven that kidneys from living donors are superior to cadaveric donors (kidneys harvested from a deceased individual). Kidneys from living donors are not exposed to extremely low temperature that could increase post-operative problems. They are less likely to experience rejection and there is a decreased likelihood that a patient will have to undergo post-operative dialysis. The objective of this study is to promote the enrollment of healthy individuals to serve as kidney donors for patients undergoing research kidney transplantation at the NIH. Potential donors will be screened to make sure they are able to survive with a single kidney without significant medical risk. Additional tests will be taken to establish compatibility with the recipient. Compatible donors will be evaluated to determine which kidney is suitable for transplantation. Both the donation and transplantation procedure will be conducted on the same day. Appropriate post-operative care and follow-up will be provided at the Clinical Center.
Details: This protocol is designed to facilitate the enrollment of healthy individuals to serve as renal allograft donors for subjects undergoing protocol renal transplantation at the NIH. Donation will be allowed for altruistic purposes only.
Eligibility:
Study Type:  Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Willingness to donate without evidence of secondary gain, coercion, or conflict of interest. Age greater than or equal to 18 years ABO compatible with recipient Normal renal function with a 24hr creatinine clearance greater than 80ml/min/1.73m(2). Willingness and legal ability to give informed consent Recipient is enrolled in a NIH protocol for transplantation or has been established as a candidate for receipt of an altruistic or paired donation through the Washington Regional Organ Procurement Agency donor program. EXCLUSION CRITERIA: Hypertension Pregnancy History of stroke Active tuberculosis History of active malignancies except basal cell carcinoma of the skin. Major anticipated illness or organ failure incompatible with survival after nephrectomy Functionally significant coronary artery disease. Active kidney stones Proteinuria (greater than 250mg/24hr)
Total Enrollment: 999

Location and Contact Information:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Patient  and Public Liaison Office 1-800-411-1222


Additional Information:
Study ID Numbers:  990107;  99-DK-0107
Study Start Date: May 17, 1999
Record last reviewed: April 7, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001856

Other Kidney Transplantation Studies:
1. A Study of the Safety and Effectiveness of Varivax (the Chicken Pox Vaccine) in Children Who Have Received Kidney Transplants

2. Antibody and Delayed Cyclosporine versus Initial Cyclosporine Alone in Patients Receiving Kidney Transplants

3. Study comparing the safety and efficacy of BMS-224818 to cyclosporine, in patients receiving a kidney transplant, when used in combination with CellCept, Simulect, and corticosteroids.

4. A Study To Test An Anti-Rejection Therapy After Kidney Transplantation

5. Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant

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