NCT00452049

Brief Summary

Secondary hyperparathyroidism (HPT) is a known complication of chronic renal failure. Elevated concentrations of parathyroid hormone (PTH) play a role not only in the pathogenesis of renal bone disease, but also in the development of cardiovascular risk factors such as disturbed lipid metabolism, glucose intolerance, and hypertension. HPT is also known to play an important role in the development of structural abnormalities of both large arteries and the heart (left ventricular hypertrophy, interstitial fibrosis). In the last couple of years there has been increasing evidence from animal studies that the endothelium is a target organ of PTH. Hypothesis: PTH has clinically relevant effects on renal hemodynamics, renal function and endothelial function. Aims:

  1. 1.To evaluate the effect of parathyroidectomy (PTX) on renal hemodynamics in stable renal transplant recipients
  2. 2.To evaluate the effect of PTX on endothelial function in stable renal transplant recipients/chronic kidney disease (CKD) stage 5 patients
  3. 3.To evaluate the effect of PTX on blood pressure in stable renal transplant recipients/CKD stage 5 patients

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 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

April 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2007

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

First QC Date

March 23, 2007

Last Update Submit

May 28, 2012

Conditions

Keywords

parathyroidectomyarterial stiffnessrenal function

Interventions

parathyroidectomy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Renal transplant recipients

You may qualify if:

  • Stable renal transplant recipients/CKD stage 5D patients.
  • Age between 18 years and 85 years.
  • Signed informed consent.
  • PTX scheduled because of severe hyperparathyroidism (day 0)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hopsital Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (1)

  • Evenepoel P, Claes K, Viaene L, Bammens B, Meijers B, Naesens M, Sprangers B, Kuypers D. Decreased Circulating Sclerostin Levels in Renal Transplant Recipients With Persistent Hyperparathyroidism. Transplantation. 2016 Oct;100(10):2188-93. doi: 10.1097/TP.0000000000001311.

MeSH Terms

Conditions

HyperparathyroidismHypertension

Interventions

Parathyroidectomy

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Pieter Evenepoel, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pieter Evenepoel, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 23, 2007

First Posted

March 26, 2007

Study Start

April 1, 2005

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations