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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
Sponsor:
Information provided by (Responsible Party):
Centro Hospitalar de Lisboa Central

Brief 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.


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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
de novo renal transplanted patients
renal transplanted patients
Other: transplanted patients
bone biopsy, echocardiogram, blood samples




Primary Outcome Measures :
  1. Metabolic Bone Diseases [ Time Frame: 12 months ]
    Histological pattern of bone disease

  2. Cardiovascular disease [ Time Frame: 12 months ]
    left ventricular hypertrophy, myocardial infarction, congestive heart failure, arrhythmia


Secondary Outcome Measures :
  1. Bone fracture [ Time Frame: 12 months ]
    Bone fracture

  2. vascular calcification [ Time Frame: 12 months ]
    hands and pelvis vascular calcification


Biospecimen Retention:   Samples Without DNA
serum and bone biopsy


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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
de novo renal transplanted patients, admitted to our renal transplantation unit.
Criteria

Inclusion Criteria:

  • Patients eligible for kidney transplantation.

Exclusion Criteria:

  • mental retardation,
  • liver-kidney transplantation.

Information from the National Library of Medicine

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


Locations
Portugal
Nephrology Department, Centro Hospitalar de Lisboa Central
Lisboa, Portugal, 1069-639
Sponsors and Collaborators
Centro Hospitalar de Lisboa Central
Investigators
Principal Investigator: Ana-Carina Ferreira, MD Nephrology Department, Centro Hospitalar de Lisboa Central

Responsible Party: Centro Hospitalar de Lisboa Central
ClinicalTrials.gov Identifier: NCT02751099     History of Changes
Other Study ID Numbers: CHLC.CI363.2016
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Vascular Diseases
Renal Insufficiency
Bone Diseases
Renal Insufficiency, Chronic
Bone Diseases, Metabolic
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Musculoskeletal Diseases
Metabolic Diseases