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

October 24, 2017 updated by: Universitaire Ziekenhuizen KU Leuven

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven Gasthuisberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

end stage renal disease patients able to consent

Description

Inclusion Criteria:

  • eligible for renal transplantation and >18 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the start of the study
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
after 1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Pieter Evenepoel, MD,PhD, UZ Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2010

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (Estimate)

June 26, 2013

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s52091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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