NCT02751099

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

2.9 years

First QC Date

April 21, 2016

Last Update Submit

August 2, 2018

Conditions

Chronic Renal InsufficiencyDisorder Related to Renal TransplantationMetabolic Bone DiseasesVascular Disease

Outcome Measures

Primary Outcomes (2)

  • Metabolic Bone Diseases

    Histological pattern of bone disease

    12 months

  • Cardiovascular disease

    left ventricular hypertrophy, myocardial infarction, congestive heart failure, arrhythmia

    12 months

Secondary Outcomes (2)

  • Bone fracture

    12 months

  • vascular calcification

    12 months

Study Arms (1)

de novo renal transplanted patients

renal transplanted patients

Other: transplanted patients

Interventions

transplanted patientsOTHER

bone biopsy, echocardiogram, blood samples

de novo renal transplanted patients

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

de novo renal transplanted patients, admitted to our renal transplantation unit.

You may qualify if:

  • Patients eligible for kidney transplantation.

You may not qualify if:

  • mental retardation,
  • liver-kidney transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology Department, Centro Hospitalar de Lisboa Central

Lisbon, 1069-639, Portugal

Location

Related Publications (2)

  • Ferreira AC, Mendes M, Silva C, Cotovio P, Aires I, Navarro D, Caeiro F, Salvador R, Correia B, Cabral G, Nolasco F, Ferreira A. Biochemical Clusters as Substitutes of Bone Biopsies in Kidney Transplant Patients. Calcif Tissue Int. 2024 Mar;114(3):267-275. doi: 10.1007/s00223-023-01173-1. Epub 2024 Jan 22.

    PMID: 38253933DERIVED

  • Ferreira AC, Mendes M, Silva C, Cotovio P, Aires I, Navarro D, Caeiro F, Ramos R, Salvador R, Correia B, Cabral G, Nolasco F, Ferreira A. Improvement of Mineral and Bone Disorders After Renal Transplantation. Transplantation. 2022 May 1;106(5):e251-e261. doi: 10.1097/TP.0000000000004099. Epub 2022 Mar 8.

    PMID: 35266925DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and bone biopsy

MeSH Terms

Conditions

Renal Insufficiency, ChronicBone Diseases, MetabolicVascular Diseases

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCardiovascular Diseases

Study Officials

  • Ana-Carina Ferreira, MD

    Nephrology Department, Centro Hospitalar de Lisboa Central

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 21, 2016

First Posted

April 26, 2016

Study Start

November 1, 2015

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

August 3, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)