Live Donors for Kidney Transplants

NCT ID: NCT00001856

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-05-17

Study Completion Date

2014-05-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Transplantation

Keywords

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Living Donor Transplantation Nephrectomy

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role lead

Principal Investigators

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Monique E Cho, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 7918142 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3154482 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8475549 (View on PubMed)

Other Identifiers

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99-DK-0107

Identifier Type: -

Identifier Source: secondary_id

990107

Identifier Type: -

Identifier Source: org_study_id