Kidney DiseasesNCT00846729
Comparative Renal Function of Young (18-45 Years) and Ageing (55 Years and Above) Kidney Donors
An observational study of Kidney Diseases, run by Stanford University at 1 site in United States.
Trial summary
It is our purpose in this study to compare the kidney structure and function of older patients to that of young patients before and after removal of a single kidney for transplant donation and to examine the remaining kidney's ability to adapt and maintain function over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- CT angiogram of the remaining kidney. and Kidney Function study using Iothalamate & PAH as clearance markers
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Dec 2012
- 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
Study population: 1. Men and Women who are undergoing surgery for kidney donation for transplantation who are between the ages of 18 and 45, and 55 and above. 2. Men and women who are undergoing surgery for kidney donation for transplantation who exhibit mild hypertension. 3. Men and women who donated a kidney for transplantation 10 to 20 years ago.
Inclusion Criteria:1. Patients who are over the age of 18. 2. Patients who are undergoing surgical uninephrectomy for the purpose of living donation for transplantation 3. Adults who had a single kidney removed for transplant donation 10-20 years ago.
- All Patients enrolled in this study must be between the ages of 18 and 45 years or 55 years or older.
- Patients undergoing surgery for kidney donation who exhibit mild hypertension controlled with one medication. Any age accepted Exclusion Criteria:1. Patients under the age of 18.
- Patients between the ages of 46 and 54 3. Patients who are allergic to Inulin, Iothalamate, or PAH. 4. Women who are pregnant. 5. Other "Vulnerable Subjects"
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Preserving Renal Longevity in Living Kidney Donors
It is our purpose in this study to compare the kidney structure and function of older patients to that of young patients before and after removal of a single kidney for transplant donation and to examine the remaining kidney's ability to adapt and maintain function over time. More specifically, we aim to examine the effect of uninephrectomy on adaptive hyperfiltration in the remaining kidney. A secondary aim is to investigate whether subjects in the aging population undergo compensation to the same extent as younger subjects. We will also examine the compensatory rise in GFR (glomerular filtration rate) that follows uninephrectomy in both groups, and, again, compare the results in the aged versus young subjects. This will help in delineating the extent to which the aging population can be a potential source of living kidney donors for kidney transplantation.
It is also our purpose with this study to refine the tests to be used in the donor evaluation process so as to accurately identify ideal candidates for safe kidney donation.
Read the detailed description
Screening Procedures: Patients will be identified after acceptance by Stanford's kidney transplant team as appropriate candidates for living kidney donation prior to their surgery.
The following assessments will be performed over the course of 4 years for this protocol.
- Informed Consent will be obtained.
- A Cimetidine Blocked 24 hour urine collection will be obtained prior to surgery.
- DETAILED KIDNEY FUNCTION STUDIES will be performed using iothalamate, and PAH at three different times:
- Prior to surgery for uninephrectomy (the night before to months before surgery)
- 6 months to 1 year post kidney donation.
- 4 years after kidney donation.
- The Structure of the Kidney will also be assessed at three different times during this protocol:
- Cortical and whole kidney volumes will be determined using the clinical MRI or CT performed routinely for kidney donor evaluation.
- At the time of surgery, in the operating room: A single wedge biopsy of the kidney will be taken for morphometric and later genetic analysis. *NOTE: Genetic analysis is for the genetics of ageing not disease. In this procedure, a small wedge kidney biopsy is excised under direct visualization by the transplant surgeon after the kidney has been removed from the donor and before the kidney is transplanted into the recipient. The area of excision is then oversewn and checked for bleeding. The size (volume) of the Tx kidney will be measured by water displacement in a graduated cylinder immediately before Tx. This volume will be used in our calculations to estimate the number of glomeruli in youthful vs ageing kidneys.
- A second MRI or CT will be obtained 6 months to 1 year after kidney donation to measure the kidney's overall compensatory growth and increase in cortical volume for comparison with the pre-operative volumes.
- Conditions
- Kidney Diseases
- Being tested
- CT angiogram of the remaining kidney., Kidney Function study using Iothalamate & PAH as clearance markers
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT angiogram of the remaining kidney.Procedure or surgery
Kidney Function study using Iothalamate & PAH as clearance markersProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Diminished adaptive response to living kidney donation in ageing donors as compared to living donors.
Measured: 4 years
Secondary outcomes (1)
Renal Failure & new onset, or worsening, of hypertension in living kidney donors
Measured: 4 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startMar 2003
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane C. Tan, Stanford University
- Investigators
- Bryan D Myers, Principal investigator, Stanford UniversityJane C. Tan, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846729
- Sponsor's protocol ID
- SU-02092009-1778
- Other IDs
- IRB eProtocol #13584, SPO 45339
- Status last verified
- Apr 2018
- First submitted
- 17 Feb 2009
- Last updated
- 30 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preserving Renal Longevity in Living Kidney Donors
- ClinicalTrials.gov ID
- NCT00846729
- Acronym / sponsor ID
- SU-02092009-1778
- Conditions
- Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Feb 2009 (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.
It is our purpose in this study to compare the kidney structure and function of older patients to that of young patients before and after removal of a single kidney for transplant donation and to examine the remaining kidney's ability to adapt and maintain function over time. More specifically, we aim to examine the effect of uninephrectomy on adaptive hyperfiltration in the remaining kidney. A secondary aim is to investigate whether subjects in the aging population undergo compensation to the same extent as younger subjects. We will also examine the compensatory rise in GFR (glomerular filtration rate) that follows uninephrectomy in both groups, and, again, compare the results in the aged versus young subjects. This will help in delineating the extent to which the aging population can be a potential source of living kidney donors for kidney transplantation.
It is also our purpose with this study to refine the tests to be used in the donor evaluation process so as to accurately identify ideal candidates for safe kidney donation.
Detailed description
Screening Procedures: Patients will be identified after acceptance by Stanford's kidney transplant team as appropriate candidates for living kidney donation prior to their surgery.
The following assessments will be performed over the course of 4 years for this protocol.
- Informed Consent will be obtained.
- A Cimetidine Blocked 24 hour urine collection will be obtained prior to surgery.
- DETAILED KIDNEY FUNCTION STUDIES will be performed using iothalamate, and PAH at three different times:
- Prior to surgery for uninephrectomy (the night before to months before surgery)
- 6 months to 1 year post kidney donation.
- 4 years after kidney donation.
- The Structure of the Kidney will also be assessed at three different times during this protocol:
- Cortical and whole kidney volumes will be determined using the clinical MRI or CT performed routinely for kidney donor evaluation.
- At the time of surgery, in the operating room: A single wedge biopsy of the kidney will be taken for morphometric and later genetic analysis. *NOTE: Genetic analysis is for the genetics of ageing not disease. In this procedure, a small wedge kidney biopsy is excised under direct visualization by the transplant surgeon after the kidney has been removed from the donor and before the kidney is transplanted into the recipient. The area of excision is then oversewn and checked for bleeding. The size (volume) of the Tx kidney will be measured by water displacement in a graduated cylinder immediately before Tx. This volume will be used in our calculations to estimate the number of glomeruli in youthful vs ageing kidneys.
- A second MRI or CT will be obtained 6 months to 1 year after kidney donation to measure the kidney's overall compensatory growth and increase in cortical volume for comparison with the pre-operative volumes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Men and Women who are undergoing surgery for kidney donation for transplantation who are between the ages of 18 and 45, and 55 and above. 2. Men and women who are undergoing surgery for kidney donation for transplantation who exhibit mild hypertension. 3. Men and women who donated a kidney for transplantation 10 to 20 years ago.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT angiogram of the remaining kidney. | Procedure or surgery | – |
| Kidney Function study using Iothalamate & PAH as clearance markers | Procedure or surgery | – |
Primary outcome
Diminished adaptive response to living kidney donation in ageing donors as compared to living donors.
Time frame: 4 years
1 secondary outcome
Renal Failure & new onset, or worsening, of hypertension in living kidney donors
Time frame: 4 yr
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 30 Apr 2018.
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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.
Bryan D Myers principal investigator
Stanford University
Jane C. Tan principal investigator
Stanford University
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 Diseases, run by Stanford University 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?
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 30 Apr 2018. 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.
What does the primary outcome measure?
Diminished adaptive response to living kidney donation in ageing donors as compared to living donors. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2018.