Serum Uremic Toxins and Histological Findings of the Blood Vessels in Dialysis Patients

NCT00412139 | Completed DMC

• 1 other identifier: 13-1001/2-05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients treated by chronic renal replacement therapy are exposed to cardiovascular problems and suffer from an accelerated and sever atherosclerosis. Classical risk factors for atherosclerosis and cardiovascular diseases (CVD) do not explain the full risk of CVD in the dialysis patients. Additional risk factors are therefore likely to exist. The uremic syndrome is attributed to the progressive retention of a large number of compounds, which under normal conditions are excreted by the healthy kidneys. Uremic toxins such are parathormone (PTH), vitamin D and phosphates, cause development of renal osteodystrophy (ROD), i.e. disordered calcium and phosphate metabolism. Both conditions of hyperparathyroid and adynamic bone disease (ABD) lead to an elevated calcium x phosphate product and increased vascular calcification, which might occur in intimal and medial layer of the vessel wall. It is important to consider these processes separately, as the vascular consequences (occlusion with atheromatosis and vascular stiffening through medial calcification) are different. Moreover, the difference between uremic and non-uremic intimal plaque is not the size but its composition, with markedly increased calcium content. Hence, these observations have an important socio-economic impact because of the increased cardiovascular morbidity and mortality. The investigators hypothesized that uremic toxins in dialysis patients influence directly and/or indirectly the development of atherosclerosis, vascular calcifications and CVD.

Conditions

Chronic Renal Failure

Keywords

vascular calcifications; uremic toxins; renal osteodystrophy; Dialysis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CKD patients with a need for dialysis within a few months CKD patients on dialysis with thormbosis of AV fistula CKD patients on dialysis scheduled for kidney transplantation

You may qualify if:

• Chronic renal failure patients with a need for creation of AV fistula
• Dialysis patients with a need of reanastomosing of the AV fistula (thrombosis or insufficient blood flow)

You may not qualify if:

• Diabetes
• Malignant disease
• Prior treatment with corticosteroids

Sponsors & Collaborators

• University of Skopje: lead
• Ministry of Science and Education, R. Macedonia: collaborator

Study Sites (1)

Department of Nephrology, University Clinical Center

Skopje, 1000, North Macedonia

Location

Biospecimen

Retention: NONE RETAINED

3 aliquots of 2-3 ml sera are retained for various uremic markers determination

MeSH Terms

Conditions

Kidney Failure, Chronic; Vascular Calcification; Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Goce Spasovski, MD, PhD

  Department of Nephrology, University Clinical Center, Vodnjanska 17, 1000 Skopje, R. Macedonia

  PRINCIPAL INVESTIGATOR

• Momir Polenakovic, MD, PhD

  Macedonian Academy of Science and Arts

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 15, 2006
• Study Start: December 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: January 1, 2010
• Last Updated: February 9, 2010

Record last verified: 2008-12

Locations

NO (1)