Arterial CalcificationNCT05697458
Vascular Calcifications in Kidney Transplant Recipient
An observational study of Arterial Calcification and Kidney Failure, run by Clinical Hospital Center Rijeka at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Arterial Calcification, Kidney Failure, Kidney Transplant; Complications
- What is being tested?
- computerized tomography scanning
- How many people
- 70 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Dec 2022to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo kidney transplantation in Clinical Hospital Centre Rijeka, following non-contrast CT evaluation will be included in the study.
Who may be able to join
- end-stage renal disease
- operated patients (kidney transplantation)
- both gender
- older than 18 years
- written informed consent
Who cannot join
- age younger of 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- computerized tomography scanning
- Keywords
- kidney transplantation, end stage renal disease, arterial calcifications
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized tomography scanningOther
In all patients the investigators will perform CT for determination of iliac arteries calcifications
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: computerized tomography scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of iliac artery calcifications
Determination of iliac artery calcifications using CT
Measured: one year
Distribution of iliac artery calcifications
Determination of distribution of iliac artery calcifications using CT
Measured: one year
Determination of bone remodeling biomarker (calcium)
From the blood the bone remodeling biomarker (calcium) will be determine (mmol/l).
Measured: one year
Determination of bone remodeling biomarker (phosphorus)
From the blood the bone remodeling biomarker (phosphorus) will be determine (mmol/l)
Measured: one year
Determination of bone remodeling biomarker (PTH)
From the blood the bone remodeling biomarker (PTH) will be determine (pmol/l)
Measured: one year
Determination of bone remodeling biomarker (OPG)
From the blood the bone remodeling biomarker (OPG) will be determine.
Measured: one year
Determination of bone remodeling biomarker (RANKL)
From the blood the bone remodeling biomarker (RANKL) will be determine.
Measured: one year
Determination of bone remodeling biomarker (GLP)
From the blood the bone remodeling biomarker (GlP) will be determine.
Measured: one year
Secondary outcomes (2)
Correlation of iliac artery calcifications with graft and overall survival in kidney transplantation patients
The investigators will found possible correlation between graft and patient survival in kidney transplantation patients
Measured: one year
Relationship between vascular calcification burden and the serum level of bone remodeling biomarkers
The investigators will try to found correlation between vascular calcifications and serum level of bone remodeling biomarkers.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Dec 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Arterial CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center Rijeka
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rijeka
- Responsible party
- Sponsor
- Investigators
- Dean Markić, Assoc.Prof., Study chair, Clinical Hospital Center Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697458
- Sponsor's protocol ID
- 3105
- Status last verified
- Feb 2024
- First submitted
- 26 Dec 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zuza I, Dodig D, Brumini I, Tokmadzic D, Orlic L, Zgrablic D, Vukelic I, Grskovic A, Katalinic N, Jaksic A, Miletic D, Racki S, Markic D. A CT-based pelvic calcification score in kidney transplant patients is a possible predictor of graft and overall survival. Br J Radiol. 2022 Oct 1;95(1139):20220394. doi: 10.1259/bjr.20220394. Epub 2022 Oct 6.
PubMed 36116132Davis B, Marin D, Hurwitz LM, Ronald J, Ellis MJ, Ravindra KV, Collins BH, Kim CY. Application of a Novel CT-Based Iliac Artery Calcification Scoring System for Predicting Renal Transplant Outcomes. AJR Am J Roentgenol. 2016 Feb;206(2):436-41. doi: 10.2214/AJR.15.14794.
PubMed 26797375Disthabanchong S, Vipattawat K, Phakdeekitcharoen B, Kitiyakara C, Sumethkul V. Abdominal aorta and pelvic artery calcifications on plain radiographs may predict mortality in chronic kidney disease, hemodialysis and renal transplantation. Int Urol Nephrol. 2018 Feb;50(2):355-364. doi: 10.1007/s11255-017-1758-9. Epub 2017 Dec 13.
PubMed 29236239Park WY, Park SB, Han S. Long-term Clinical Outcome of Aortic Arch Calcification in Kidney Transplant Recipients. Transplant Proc. 2017 Jun;49(5):1027-1032. doi: 10.1016/j.transproceed.2017.03.072.
PubMed 28583520Benjamens S, Alghamdi SZ, Rijkse E, Te Velde-Keyzer CA, Berger SP, Moers C, de Borst MH, Slart RHJA, Dor FJMF, Minnee RC, Pol RA. Aorto-Iliac Artery Calcification and Graft Outcomes in Kidney Transplant Recipients. J Clin Med. 2021 Jan 17;10(2):325. doi: 10.3390/jcm10020325.
PubMed 33477285
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Prognostic Value of Iliac Arterial Calcifications Determined With Computerized Tomography and Bone Remodeling Biomarkers in Patients With Kidney Transplantation
- ClinicalTrials.gov ID
- NCT05697458
- Acronym / sponsor ID
- 3105
- Keywords
- kidney transplantation, end stage renal disease, arterial calcifications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Clinical Hospital Center RijekaUniversity, hospital or other
- Collaborators
- University of Rijeka
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients | – | Other: computerized tomography scanningIn 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo kidney transplantation in Clinical Hospital Centre Rijeka, following non-contrast CT evaluation will be included in the study.
Key inclusion criteria (5 listed)
- end-stage renal disease
- operated patients (kidney transplantation)
- both gender
- older than 18 years
- written informed consent
Key exclusion criteria (1 listed)
- age younger of 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computerized tomography scanningIn all patients the investigators will perform CT for determination of iliac arteries calcifications | Other | Kidney transplant recipients |
Primary outcome
Incidence of iliac artery calcifications
Time frame: one year
Determination of iliac artery calcifications using CT
Distribution of iliac artery calcifications
Time frame: one year
Determination of distribution of iliac artery calcifications using CT
Determination of bone remodeling biomarker (calcium)
Time frame: one year
From the blood the bone remodeling biomarker (calcium) will be determine (mmol/l).
Determination of bone remodeling biomarker (phosphorus)
Time frame: one year
From the blood the bone remodeling biomarker (phosphorus) will be determine (mmol/l)
Determination of bone remodeling biomarker (PTH)
Time frame: one year
From the blood the bone remodeling biomarker (PTH) will be determine (pmol/l)
Determination of bone remodeling biomarker (OPG)
Time frame: one year
From the blood the bone remodeling biomarker (OPG) will be determine.
Determination of bone remodeling biomarker (RANKL)
Time frame: one year
From the blood the bone remodeling biomarker (RANKL) will be determine.
Determination of bone remodeling biomarker (GLP)
Time frame: one year
From the blood the bone remodeling biomarker (GlP) will be determine.
2 secondary outcomes
Correlation of iliac artery calcifications with graft and overall survival in kidney transplantation patients
Time frame: one year
Relationship between vascular calcification burden and the serum level of bone remodeling biomarkers
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 36116132Zuza I, Dodig D, Brumini I, Tokmadzic D, Orlic L, Zgrablic D, Vukelic I, Grskovic A, Katalinic N, Jaksic A, Miletic D, Racki S, Markic D. A CT-based pelvic calcification score in kidney transplant patients is a possible predictor of graft and overall survival. Br J Radiol. 2022 Oct 1;95(1139):20220394. doi: 10.1259/bjr.20220394. Epub 2022 Oct 6.
- Background: PubMed 26797375Davis B, Marin D, Hurwitz LM, Ronald J, Ellis MJ, Ravindra KV, Collins BH, Kim CY. Application of a Novel CT-Based Iliac Artery Calcification Scoring System for Predicting Renal Transplant Outcomes. AJR Am J Roentgenol. 2016 Feb;206(2):436-41. doi: 10.2214/AJR.15.14794.
- Background: PubMed 29236239Disthabanchong S, Vipattawat K, Phakdeekitcharoen B, Kitiyakara C, Sumethkul V. Abdominal aorta and pelvic artery calcifications on plain radiographs may predict mortality in chronic kidney disease, hemodialysis and renal transplantation. Int Urol Nephrol. 2018 Feb;50(2):355-364. doi: 10.1007/s11255-017-1758-9. Epub 2017 Dec 13.
- Background: PubMed 28583520Park WY, Park SB, Han S. Long-term Clinical Outcome of Aortic Arch Calcification in Kidney Transplant Recipients. Transplant Proc. 2017 Jun;49(5):1027-1032. doi: 10.1016/j.transproceed.2017.03.072.
- Background: PubMed 33477285Benjamens S, Alghamdi SZ, Rijkse E, Te Velde-Keyzer CA, Berger SP, Moers C, de Borst MH, Slart RHJA, Dor FJMF, Minnee RC, Pol RA. Aorto-Iliac Artery Calcification and Graft Outcomes in Kidney Transplant Recipients. J Clin Med. 2021 Jan 17;10(2):325. doi: 10.3390/jcm10020325.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean Markić, Assoc.Prof. study chair
Clinical Hospital Center Rijeka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Calcification and Kidney Failure, run by Clinical Hospital Center Rijeka at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of iliac artery calcifications (time frame: one year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05697458, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.