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NCT Number: NCT01886950

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

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

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven Gasthuisberg

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • eligible for renal transplantation and >18 years

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. bone turnover, as assessed by bone biopsy

    Time frame: 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

  2. Evolution of bone turnover, as assessed by bone biopsy

    Time frame: after 1 year

    to evoluation the evolution of bone turnover after succesfull renal transplantation

  3. aortic calcification, as assessed by lumbar X-ray

    Time frame: 1 year

    the assess the evolution of (the degree of) aortic calcification one year after succesfull renal transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Pieter Evenepoel, MD, PhD

CONTACT

[email protected]

003216344591

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2013
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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