Live Donors for Kidney Transplants

NCT00001856 | Completed

• 2 other identifiers: 99010799-DK-0107
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplantation

Keywords

Living Donor; Transplantation; Nephrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Cecka JM, Terasaki PI. The UNOS Scientific Renal Transplant Registry. Clin Transpl. 1993:1-18.

  PMID: 7918142 BACKGROUND

• Cicciarelli J. Living donor kidney transplants. Clin Transpl. 1988:293-9.

  PMID: 3154482 BACKGROUND

• Matas AJ, Gillingham KJ, Sutherland DE. Half-life and risk factors for kidney transplant outcome--importance of death with function. Transplantation. 1993 Apr;55(4):757-61. doi: 10.1097/00007890-199304000-00014.

  PMID: 8475549 BACKGROUND

Study Officials

• Monique E Cho, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: May 17, 1999
• Study Completion: May 30, 2014
• Last Updated: December 9, 2019

Record last verified: 2014-05-30

Locations

US (1)