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

Chronic Kidney Disease Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01886950
• Other study ID #: s52091
• Status: Recruiting
• Phase: N/A
• First received: June 12, 2013
• Last updated: October 24, 2017
• Start date: August 1, 2010
• Est. completion date: December 2018

Study information

• Verified date: October 2017
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Pieter Evenepoel, MD, PhD
• Phone: 003216344591
• Email: pieter.evenepoel[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• eligible for renal transplantation and >18 years

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Calcinosis
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Vascular Calcification

Locations

Country	Name	City	State
Belgium	UZ Leuven Gasthuisberg	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

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