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Cardiovascular-Renal Consequences of Reducing Renal Mass After Living Kidney Donation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564966
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
Yasar Caliskan, Istanbul University

Brief Summary:
  • A reduce in renal mass may result in remnant single nephron hyperfiltration, with associated proteinuria and an accelerated loss of kidney function.
  • Live-donor kidney transplantation is generally considered the best choice for patients who have renal failure and are awaiting transplantation, because these kidneys function better than kidneys from deceased donors, and waiting times for deceased-donor transplants are long
  • Although several studies have shown that kidney donation has low short-term morbidity and mortality, the data on long-term outcomes are much less complete.
  • This study is designed to prospectively evaluate the effects of unilateral nephrectomy on cardiovascular-renal functions of donors after living kidney donation: the development of hypertension, albuminuria, renal failure, inflammatory and endothelial changes.

Condition or disease
Kidney Failure Hypertension Albuminuria Renal Failure Inflammation Endothelial Dysfunction

Detailed Description:

Renal dysfunction is associated with accelerated cardiovascular disease even when kidney function is only mildly impaired. Besides, even levels of urinary albumin excretion below the accepted threshold for microalbuminuria are associated with increased cardiovascular risk, and the risk increases as the degree of proteinuria rises.

  • Live-donor kidney transplantation is generally considered the best choice for patients who have renal failure and are awaiting transplantation, because these kidneys function better than kidneys from deceased donors, and waiting times for deceased-donor transplants are long. Although several studies have shown that kidney donation has low short-term morbidity and mortality, the data on long-term outcomes are much less complete. The short and long term renal functions of donors after kidney donation were much studied and still remain uncertain, the cardiovascular effects of reduction in renal mass in kidney donors is also not clearly known.
  • Endothelial dysfunction (ED) is the first step for subsequent development of atherosclerosis, which can help us to assess the cardiovascular changes after kidney donation. Prospectively examining the endothelial consequences of uninephrectomy in donors may provide useful insight into the existence and pathophysiology of cardiovascular disease in donors and, therefore, into how the cardiovascular disease risk associated with renal impairment might eventually be reduced.

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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular-Renal Consequences of Reducing Renal Mass After Living Kidney Donation
Study Start Date : April 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Group/Cohort
Living kidney donors
Those who donate kidneys




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Living kidney donors in Istanbul Faculty of Medicine
Criteria

Inclusion Criteria:

  • living kidney donors
  • Ages of 18 and 70
  • Creatinine clearance at donation > 80 ml/min/1.73 m2

Exclusion Criteria:

  • Low (< 80 ml/min/1.73 m2) creatinine clearance at donation
  • Diabetes mellitus
  • Hypertension
  • Valvular heart disease, any prior coronary intervention
  • Congestive heart failure (New York Heart Association class II or greater)
  • Cardiac arrhythmia
  • A history of cerebral infarction or transient ischemic attack
  • Active infection or non-infectious overt inflammation

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): NCT01564966


Locations
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Turkey
Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Istanbul, Turkey, 34093
Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Alaattin Yildiz, Professor of Medicine, MD Istanbul University, Istanbul Faculty of Medicine
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Responsible Party: Yasar Caliskan, Specialist of Nephrology, MD, Istanbul University
ClinicalTrials.gov Identifier: NCT01564966    
Other Study ID Numbers: 20120209
4369 ( Other Identifier: Istanbul University Scientific Research Projects )
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012
Keywords provided by Yasar Caliskan, Istanbul University:
transplantation
inflammation
endothelial dysfunction
Additional relevant MeSH terms:
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Renal Insufficiency
Albuminuria
Inflammation
Pathologic Processes
Kidney Diseases
Urologic Diseases
Proteinuria
Urination Disorders
Urological Manifestations