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

NCT ID: NCT01564966

Last Updated: 2012-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-12-31

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.

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.

Conditions

Kidney Failure; Hypertension; Albuminuria; Renal Failure; Inflammation; Endothelial Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Living kidney donors

Those who donate kidneys

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Yasar Caliskan

Specialist of Nephrology, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaattin Yildiz, Professor of Medicine, MD

Role: STUDY_DIRECTOR

Istanbul University

Locations

Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

4369

Identifier Type: OTHER

Identifier Source: secondary_id

20120209

Identifier Type: -

Identifier Source: org_study_id