Vascular Calcifications in Kidney Transplant Recipient

NCT05697458 | Completed

• 1 other identifier: 3105
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Calcification; Kidney Failure; Kidney Transplant; Complications

Keywords

kidney transplantation; end stage renal disease; arterial calcifications

Outcome Measures

Primary Outcomes (8)

• Incidence of iliac artery calcifications

  Determination of iliac artery calcifications using CT

  one year

• Distribution of iliac artery calcifications

  Determination of distribution of iliac artery calcifications using CT

  one year

• Determination of bone remodeling biomarker (calcium)

  From the blood the bone remodeling biomarker (calcium) will be determine (mmol/l).

  one year

• Determination of bone remodeling biomarker (phosphorus)

  From the blood the bone remodeling biomarker (phosphorus) will be determine (mmol/l)

  one year

• Determination of bone remodeling biomarker (PTH)

  From the blood the bone remodeling biomarker (PTH) will be determine (pmol/l)

  one year

• Determination of bone remodeling biomarker (OPG)

  From the blood the bone remodeling biomarker (OPG) will be determine.

  one year

• Determination of bone remodeling biomarker (RANKL)

  From the blood the bone remodeling biomarker (RANKL) will be determine.

  one year

• Determination of bone remodeling biomarker (GLP)

  From the blood the bone remodeling biomarker (GlP) will be determine.

  one year

Secondary Outcomes (2)

• Correlation of iliac artery calcifications with graft and overall survival in kidney transplantation patients

  one year

• Relationship between vascular calcification burden and the serum level of bone remodeling biomarkers

  One year

Study Arms (1)

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

Interventions

computerized tomography scanning OTHER

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

Kidney transplant recipients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• age younger of 18 years

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead
• University of Rijeka: collaborator

Study Sites (1)

Clinical Hospital Center Rijeka

Rijeka, 51 000, Croatia

Location

Related Publications (5)

• 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.

  PMID: 36116132 BACKGROUND

• Davis 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.

  PMID: 26797375 BACKGROUND

• Disthabanchong 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.

  PMID: 29236239 BACKGROUND

• Park 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.

  PMID: 28583520 BACKGROUND

• Benjamens 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.

  PMID: 33477285 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dean Markić, Assoc.Prof.

  Clinical Hospital Center Rijeka

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 25, 2023
• Study Start: December 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)