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Comparative Renal Function of Young (18-45 Years) and Ageing (55 Years and Above) Kidney Donors

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ClinicalTrials.gov Identifier: NCT00846729
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Jane C. Tan, Stanford University

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment
Kidney Diseases Procedure: CT angiogram of the remaining kidney. Procedure: Kidney Function study using Iothalamate & PAH as clearance markers

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.

A. Informed Consent will be obtained.

B. A Cimetidine Blocked 24 hour urine collection will be obtained prior to surgery.

C. DETAILED KIDNEY FUNCTION STUDIES will be performed using iothalamate, and PAH at three different times:

  1. Prior to surgery for uninephrectomy (the night before to months before surgery)
  2. 6 months to 1 year post kidney donation.
  3. 4 years after kidney donation.

D. The Structure of the Kidney will also be assessed at three different times during this protocol:

  1. Cortical and whole kidney volumes will be determined using the clinical MRI or CT performed routinely for kidney donor evaluation.

  2. 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.

  3. 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
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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preserving Renal Longevity in Living Kidney Donors
Study Start Date : March 2003
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Diminished adaptive response to living kidney donation in ageing donors as compared to living donors. [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Renal Failure & new onset, or worsening, of hypertension in living kidney donors [ Time Frame: 4 yr ]

Biospecimen Retention:   Samples With DNA
  1. Blood samples are obtained throughout the kidney function study. These samples are analyzed for Iothalamate and PAH (markers of kidney function) only.
  2. Kidney tissue obtained by biopsy at the time of surgery are used to analyze the structure of the kidney.

No Tissue or Blood is used for genetic analysis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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.

4. All Patients enrolled in this study must be between the ages of 18 and 45 years or 55 years or older.

5. 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.

2. 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"

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846729


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Bryan D Myers Stanford University
Principal Investigator: Jane C. Tan Stanford University
More Information
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Responsible Party: Jane C. Tan, Associate Professor of Medicine (Nephrology), Stanford University
ClinicalTrials.gov Identifier: NCT00846729    
Other Study ID Numbers: SU-02092009-1778
IRB eProtocol #13584
SPO 45339
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases