Vascular Calcifications in Kidney Transplant Recipient

February 5, 2024 updated by: Clinical Hospital Center Rijeka

Evaluation and Prognostic Value of Iliac Arterial Calcifications Determined With Computerized Tomography and Bone Remodeling Biomarkers in Patients With Kidney Transplantation

Kidney transplant candidates undergo extensive diagnostic evaluation aimed at assessing their cardiovascular (CV) risk, which remains the leading cause of disability and death in this patient population. This includes among others an assessment of the iliac arterial calcification. Chronic kidney disease (CKD) patients have an increased incidence of arterial calcifications due to many factors, such as increased age, hyperparathyroidism, diabetes mellitus and hypercholesterolemia. Furthermore, the severity of pelvic arterial calcifications may impact the surgical planning of kidney transplantation (KT), choice of anastomosis site, complexity of the surgery, and patient and graft survival. Vascular calcifications are recognized as a good biomarker of overall cardiovascular burden. Although computerized tomography (CT) is the imaging modality of choice for calcification evaluation, compared to pelvic X-ray and Doppler ultrasound, it is not officially included in the guidelines of different international associations, which offer general recommendations for the assessment of iliac vessels. Nevertheless, centers are increasingly using CT in their pretransplant workup, either routinely or only in patients with increased CV risk. Also, impaired bone metabolism and its consequences have an important role in the development of vascular calcification.

The investigators will determine the relationship between calcification burden of iliac arteries which will be assessed on CT and the serum level of bone remodeling biomarkers, including parathyroid hormone, (PTH), calcium, phosphates, OPG/RANK/RANKL (engl. osteoprotegerin/receptor activator of nuclear factor (NF)-κΒ/RANK ligand) and Gla-Rich protein (GLP). According to investigator knowledge, this will be the first prospective study that will correlate the degree of iliac arteries calcification based on CT analyses with the serum level of various bone remodeling markers, and their impact on clinical outcome in kidney transplant recipients.

The investigators expect this research to improve insights into incidence and distribution of iliac artery calcifications in patients following kidney transplantation, their correlation with clinical data and bone remodeling markers and confirm the appropriateness of using computerized tomography in a routine pretransplantation work-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The hypothesis of this study is that incidence and severity of arterial calcification raise with age of the patient and time spent on hemodialysis. Additionally, poorer graft and patient survival and overall risk for future cardiovascular events correlate with the severity of arterial calcifications following successful kidney transplantation.

Study will include 50 patients who will undergo kidney transplantation. Non-contrast CT scan of abdomen and pelvis will be performed, and blood level of bone remodeling markers will be determined in all patients.

Two radiologists will independently assess the severity of iliac artery calcifications, by using quantitative scoring system developed by Davis et al. and newly developed pelvic calcification score.

Pelvic calcification score (PCS) will be determined by assessing common iliac artery (CIA) and external iliac artery (EIA) calcifications bilaterally, based on their morphology (no calcification, thin linear calcification, 1mm in thickness and bulky calcification>2mm in thickness and convex luminal margins, scores 0-3), circumference and length (no calcification, 1-25%, 26-50%, 51-75%, > 76%, scores 0-4, respectively). PCS could vary from 0-44.

Serum level of bone remodeling biomarkers will be determined on hospital admission.

Demographic and clinical data (body mass index - BMI, principal disease and additional conditions, type and duration of renal replacement therapy, KT side-and arterial segment used, hospitalization time, and graft and overall survival) will be recorded.

Patients will be followed at least one year after KT, the function of kidney transplant will be assessed by measurement of serum creatine and renal scintigraphy

Study Type

Observational

Enrollment (Actual)

70

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 Contact Backup

Study Locations

  • Croatia
      • Rijeka, Croatia, 51 000
        • Clinical Hospital Center Rijeka

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who will undergo kidney transplantation in Clinical Hospital Centre Rijeka, following non-contrast CT evaluation will be included in the study.

Description

Inclusion Criteria:

  • end-stage renal disease
  • operated patients (kidney transplantation)
  • both gender
  • older than 18 years
  • written informed consent

Exclusion Criteria:

  • age younger of 18 years

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Kidney transplant recipients

In kidney transplant recipients the investigators will perform pretransplant computerized tomography for assessment of iliac arteries calcifications.

From their blood, the bone remodeling biomarkers will be determined in the perioperative period.

The one year patient and graft survival will be determined for included patients.
Other: computerized tomography scanning
In all patients the investigators will perform CT for determination of iliac arteries calcifications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of iliac artery calcifications
Time Frame: one year
Determination of iliac artery calcifications using CT
one year
Distribution of iliac artery calcifications
Time Frame: one year
Determination of distribution of iliac artery calcifications using CT
one year
Determination of bone remodeling biomarker (calcium)
Time Frame: one year
From the blood the bone remodeling biomarker (calcium) will be determine (mmol/l).
one year
Determination of bone remodeling biomarker (phosphorus)
Time Frame: one year
From the blood the bone remodeling biomarker (phosphorus) will be determine (mmol/l)
one year
Determination of bone remodeling biomarker (PTH)
Time Frame: one year
From the blood the bone remodeling biomarker (PTH) will be determine (pmol/l)
one year
Determination of bone remodeling biomarker (OPG)
Time Frame: one year
From the blood the bone remodeling biomarker (OPG) will be determine.
one year
Determination of bone remodeling biomarker (RANKL)
Time Frame: one year
From the blood the bone remodeling biomarker (RANKL) will be determine.
one year
Determination of bone remodeling biomarker (GLP)
Time Frame: one year
From the blood the bone remodeling biomarker (GlP) will be determine.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of iliac artery calcifications with graft and overall survival in kidney transplantation patients
Time Frame: one year
The investigators will found possible correlation between graft and patient survival in kidney transplantation patients
one year
Relationship between vascular calcification burden and the serum level of bone remodeling biomarkers
Time Frame: One year
The investigators will try to found correlation between vascular calcifications and serum level of bone remodeling biomarkers.
One year

Collaborators and Investigators

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

Sponsor

Clinical Hospital Center Rijeka

Collaborators

University of Rijeka

Investigators

  • Study Chair: Dean Markić, Assoc.Prof., Clinical Hospital Center Rijeka

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)

December 1, 2022

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

December 26, 2022

First Submitted That Met QC Criteria

January 14, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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