Skip to content

Vascular Calcifications in Kidney Transplant Recipient

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05697458
Enrollment
70
Registered
2023-01-25
Start date
2022-12-01
Completion date
2024-01-31
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Calcification, Kidney Failure, Kidney Transplant; Complications

Keywords

kidney transplantation, end stage renal disease, arterial calcifications

Brief summary

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.

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

Interventions

OTHERcomputerized tomography scanning

In all patients the investigators will perform CT for determination of iliac arteries calcifications

Sponsors

University of Rijeka
CollaboratorOTHER
Clinical Hospital Center Rijeka
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determination of bone remodeling biomarker (GLP)one yearFrom the blood the bone remodeling biomarker (GlP) will be determine.
Determination of bone remodeling biomarker (OPG)one yearFrom the blood the bone remodeling biomarker (OPG) will be determine.
Determination of bone remodeling biomarker (RANKL)one yearFrom the blood the bone remodeling biomarker (RANKL) will be determine.
Incidence of iliac artery calcificationsone yearDetermination of iliac artery calcifications using CT
Distribution of iliac artery calcificationsone yearDetermination of distribution of iliac artery calcifications using CT
Determination of bone remodeling biomarker (calcium)one yearFrom the blood the bone remodeling biomarker (calcium) will be determine (mmol/l).
Determination of bone remodeling biomarker (phosphorus)one yearFrom the blood the bone remodeling biomarker (phosphorus) will be determine (mmol/l)
Determination of bone remodeling biomarker (PTH)one yearFrom the blood the bone remodeling biomarker (PTH) will be determine (pmol/l)

Secondary

MeasureTime frameDescription
Relationship between vascular calcification burden and the serum level of bone remodeling biomarkersOne yearThe investigators will try to found correlation between vascular calcifications and serum level of bone remodeling biomarkers.
Correlation of iliac artery calcifications with graft and overall survival in kidney transplantation patientsone yearThe investigators will found possible correlation between graft and patient survival in kidney transplantation patients

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026