Bone and Cardiovascular Disease After Kidney Transplant
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|ClinicalTrials.gov Identifier: NCT02751099|
Recruitment Status : Active, not recruiting
First Posted : April 26, 2016
Last Update Posted : August 3, 2018
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.
|Condition or disease||Intervention/treatment|
|Chronic Renal Insufficiency Disorder Related to Renal Transplantation Metabolic Bone Diseases Vascular Disease||Other: transplanted patients|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Bone Metabolism and Cardiovascular Risk After Kidney Transplant in Adult Patients|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||December 2018|
de novo renal transplanted patients
renal transplanted patients
Other: transplanted patients
bone biopsy, echocardiogram, blood samples
- Metabolic Bone Diseases [ Time Frame: 12 months ]Histological pattern of bone disease
- Cardiovascular disease [ Time Frame: 12 months ]left ventricular hypertrophy, myocardial infarction, congestive heart failure, arrhythmia
- Bone fracture [ Time Frame: 12 months ]Bone fracture
- vascular calcification [ Time Frame: 12 months ]hands and pelvis vascular calcification
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751099
|Nephrology Department, Centro Hospitalar de Lisboa Central|
|Lisboa, Portugal, 1069-639|
|Principal Investigator:||Ana-Carina Ferreira, MD||Nephrology Department, Centro Hospitalar de Lisboa Central|