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BOne Dysfunction in Donor NEphrectomieS

NCT04674397 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2021-12-07

No results posted yet for this study

Summary

Most dialysis patients die from vascular disease, which is statistically associated with changes related to chronic kidney disease associated mineral bone disorder (CKD-MBD)3-9. Understanding the mechanisms behind this high death rate is crucial to improving the length and quality of life for patients with all grades of kidney disease, including those on dialysis. This is a priority for patients and clinicians alike.

Most humans with early CKD are asymptomatic and unaware that they have a problem with their kidneys. Therefore they are unlikely to consult a doctor and early CKD is often unrecognised. Patients who are aware of early CKD often have other co-morbidities including diabetes, hypertension and vascular disease which, in the setting of a clinical study, complicate the identification of changes solely resulting from CKD. However over the past decade living kidney donation has become increasingly common and is now the source of organs for more than 120 patients annually at Manchester's renal transplant centre. Prospective donors are carefully examined and known to have normal kidney function without other co-morbidities. They then undergo a planned unilateral nephrectomy and lose approximately 50% of their kidney mass, creating an immediate state of moderate CKD. Over subsequent months the remaining kidney will hypertrophy and partially correct this, although the mechanisms are unknown. In the immediate post-operative period donors are inpatients on the kidney transplant ward and have regular blood and urine tests meaning that careful study of metabolic processes during their recovery is relatively easy by analysis of serial plasma and urine samples. Sequential changes in the plasma and urine levels of different bone turnover markers and metabolites can be analysed and will provide valuable new information to increase our understanding of the initial stage of CKD-MBD development.

Conditions

  • Renal Failure
  • Kidney Donors

Interventions

RADIATION

Radioisotope GFR test

Sponsors & Collaborators

  • University of Manchester

    collaborator OTHER

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-29
Primary Completion
2020-08-01
Completion
2020-08-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04674397 on ClinicalTrials.gov