Kidney TransplantationNCT00001856
Live Donors for Kidney Transplants
An observational study of Kidney Transplantation, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 1999to 30 May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Functionally significant coronary artery disease.
- Active kidney stones
- Proteinuria (greater than 250mg/24hr)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Live Donor Renal Donation for Allotransplantation
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.
Read the detailed description
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
- Kidney Transplantation
- Keywords
- Living Donor, Transplantation, Nephrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start17 May 1999
- Study completion30 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Monique E Cho, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001856
- Sponsor's protocol ID
- 990107
- Other IDs
- 99-DK-0107
- Status last verified
- 30 May 2014
- First submitted
- 3 Nov 1999
- Last updated
- 9 Dec 2019
- Results posted
- No
Publications
Cecka JM, Terasaki PI. The UNOS Scientific Renal Transplant Registry. Clin Transpl. 1993:1-18.
PubMed 7918142Cicciarelli J. Living donor kidney transplants. Clin Transpl. 1988:293-9.
PubMed 3154482Matas 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.
PubMed 8475549
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Donor Renal Donation for Allotransplantation
- ClinicalTrials.gov ID
- NCT00001856
- Acronym / sponsor ID
- 990107
- Conditions
- Kidney Transplantation
- Keywords
- Living Donor, Transplantation, Nephrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 17 May 1999
- Study completion
- 30 May 2014
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Hypertension
- Pregnancy
- History of stroke
- Active tuberculosis
- History of active malignancies except basal cell carcinoma of the skin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Background: PubMed 7918142Cecka JM, Terasaki PI. The UNOS Scientific Renal Transplant Registry. Clin Transpl. 1993:1-18.
- Background: PubMed 3154482Cicciarelli J. Living donor kidney transplants. Clin Transpl. 1988:293-9.
- Background: PubMed 8475549Matas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique E Cho, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001856, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.