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

Recruiting

• Conditions: Chronic Kidney Disease

• Registration Number: NCT01886950
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2010-08-01
• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• eligible for renal transplantation and >18 years

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

UZ Leuven Gasthuisberg; 🇧🇪 Leuven, Vlaams-Brabant, Belgium