Evolution of Bone Histomorphometry and Vascular Calcification Before and After Renal Transplantation

A Prospective Observational Study to Investigate the Natural History of Bone Histomorphometry and Vascular Calcification in Dialysis-dependent Patients Before and After Renal Transplantation.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01886950

Enrollment

250

Registered

2013-06-26

Start date

2010-08-01

Completion date

2025-12-31

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

CKD stage 5, Bone histomorphometry, Renal transplantation

Brief summary

A study of the natural history of bone and mineral disease (BMD) in patients with end-stage renal disease before and after kidney transplantation

Detailed description

Disturbances of mineral and bone diseaeses are frequently observed in CKD patients. Renal osteodystrophy is the term to describe the bone abnormalities. Epidemiological data showed adynamic bone disease (ABD) is the most frequent bone disorder in CKD stage 5D diseases. Low PTH, diabetes mellitus, malnutrition, metabolic acidosis, hypogonadism and low 1,25(OH)2D vitamin D deficiency are known risk factors for ABD. Mounting experimental data point towards a role of protein-bound uremic retention molecules (p-cresyl sulfate and indoxyl sulfate) in the pathogenesis and progression of ABD. ABD is not only recognized as a risk factor for fractures but also for arterial calcification. The aim of the present study is (1) to investigate the role of indoxyl sulfate and p-cresyl sulfate in the pathogenesis and progression of ABD and arterial calcification in CKD stage5 and (2) to investigate the influence of renal transplantation on bone and arterial metabolism.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* eligible for renal transplantation and \>18 years

Exclusion criteria

* use of biphosphonates within the 6 months before the study entry

Design outcomes

Primary

Measure	Time frame	Description
bone turnover, as assessed by bone biopsy	at the start of the study	to investigate the role of indoxyl sulfate and p-cresyl sulfate in the pathogenesis and progression of ABD and arterial calcification in CKD stage5
Evolution of bone turnover, as assessed by bone biopsy	after 1 year	to evoluation the evolution of bone turnover after succesfull renal transplantation
aortic calcification, as assessed by lumbar X-ray	1 year	the assess the evolution of (the degree of) aortic calcification one year after succesfull renal transplantation

Countries

Belgium

Contacts

Primary ContactPieter Evenepoel, MD, PhD

pieter.evenepoel@uzleuven.be003216344591

Outcome results