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

NCT00846729 | Completed

• 3 other identifiers: SU-02092009-1778IRB eProtocol #13584SPO 45339
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Diminished adaptive response to living kidney donation in ageing donors as compared to living donors.

  4 years

Secondary Outcomes (1)

• Renal Failure & new onset, or worsening, of hypertension in living kidney donors

  4 yr

Interventions

CT angiogram of the remaining kidney. PROCEDURE

Kidney Function study using Iothalamate & PAH as clearance markers PROCEDURE

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \. 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"

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

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.

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Bryan D Myers

  Stanford University

  PRINCIPAL INVESTIGATOR

• Jane C. Tan

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine (Nephrology)

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: March 1, 2003
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

US (1)