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NCT01368822 · ClinicalTrials.gov registry record

Effect of Obesity on Long-term Clinical Outcomes After Kidney Donation

A clinical trial, sponsored by University of California, San Francisco.

Completed
Registry status
150
Enrollment target

NCT01368822: Completed study, sponsored by University of California, San Francisco.

NCT01368822 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 150 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01368822 has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
150 participants
Enrollment target

Study Summary

Several studies have shown that renal function in patients who have donated a kidney (but are otherwise healthy) remains stable and within normal limits. However, it is unclear how donor nephrectomy affects patient subsets with comorbidities, an issue that becomes relevant in the current environment where inclusion criteria are continuously becoming less stringent and more patients are being considered as potential donors. In the present study, the investigators plan to evaluate long-term renal function in obese patients who have donated a kidney as part of a living donor renal transplant procedure. The investigators have selected this group because it is at higher risk for developing obesity-related complications such as diabetes and hypertension that may impair renal function, it is rapidly becoming a major subgroup in the kidney donor population, and no studies have systematically followed obese patients after kidney donation. Establishment of an appropriate control group is of primary importance in studies examining long-term outcomes. The investigators will also evaluate a 2-kidney control group to allow us to compare the individual and interactive effects of obesity and kidney donation on long-term renal function. Study participants will complete a medical questionnaire, undergo blood pressure measurements, and provide blood and urine samples for analysis of various metabolic parameters. Some study participants will have ambulatory blood pressure monitoring performed which involves application of an automated blood pressure cuff for 24 hours. Some study participants will also undergo direct measurements of glomerular filtration rate (GFR) with iohexol. In the proposed research, the investigators hypothesize that obesity in kidney donors increases the likelihood of developing renal dysfunction and risk factors for cardiovascular disease (CVD) and may increase the likelihood even more than in healthy controls.

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2010-06
Est. Completion 2012-06

What the finished NCT01368822 record still lists

NCT01368822 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01368822 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01368822 about?

NCT01368822 is a clinical study titled "Effect of Obesity on Long-term Clinical Outcomes After Kidney Donation". Several studies have shown that renal function in patients who have donated a kidney (but are otherwise healthy) remains stable and within normal limits. However, it is unclear how donor nephrectomy affects patient subsets with comorbidities, an issue that becomes relevant in the current environment...

What is the current status of trial NCT01368822?

This trial is currently completed. The enrollment target is 150 participants. The study started on 2010-06. Estimated completion is 2012-06.

Who is sponsoring clinical trial NCT01368822?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01368822, the US trial registry maintained by the National Library of Medicine. NCT01368822 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.