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Bone and Cardiovascular Disease After Kidney Transplant

NCT02751099 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2018-08-03

No results posted yet for this study

Summary

Bone disorder is a significant problem in chronic kidney disease (CKD), becoming almost universal in stage 5 CKD patients. Besides the healthcare costs, bone disorder is associated with life-threatening complications, including fractures and cardiovascular (CV) events. Kidney transplantation provides circa 68% decrease in mortality and improves co-morbidity. Still, bone disease persists after transplantation.

The investigators hypothesize that bone-derived hormones can induce CV events in kidney transplanted patients. Therefore, early evaluation of the bone health is recommended, and prevention of its complications is required. Bone biopsy, an invasive and expensive method, is the gold standard for bone disorders diagnosis. Therefore, non-invasive predictors for bone disease are necessary. Classical biochemical markers of bone formation and resorption have shown a low sensitivity and low specificity. New markers, as fibroblast growth factor 23 (FGF23), and its cofactor klotho, and sclerostin are promising new markers for predicting CKD-associated bone and CV disease after transplantation.

This study assesses the phenotype of bone disease after transplantation (given by bone histology) and its correlation with serum FGF23, klotho and sclerostin, in order to evaluate its performance predicting CKD-associated bone and CV disease.

Conditions

  • Chronic Renal Insufficiency
  • Disorder Related to Renal Transplantation
  • Metabolic Bone Diseases
  • Vascular Disease

Interventions

OTHER

transplanted patients

bone biopsy, echocardiogram, blood samples

Sponsors & Collaborators

  • Centro Hospitalar de Lisboa Central

    lead OTHER

Principal Investigators

  • Ana-Carina Ferreira, MD · Nephrology Department, Centro Hospitalar de Lisboa Central

Eligibility

Min Age
18 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-10-31
Completion
2018-12-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02751099 on ClinicalTrials.gov