Long-term Cardiovascular Risk Following Successful Renal Transplantation

August 14, 2014 updated by: Helse Stavanger HF

The Prevalence of Cardiovascular Risk Factors in Patients More Than 10 Years Following Successful Renal Transplant.

Mineral metabolism disturbances occur early during the course of chronic kidney disease and eventually affect most patients. For how long such disturbances persist after a successful renal transplantation is mainly unknown. This study will investigate the prevalence of such disturbances in patients more than 10 years following a successful renal transplantation. The patients will be recruited from an existing registry in Norway.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Stavanger, Norway, NO-4011
        • Stavanger University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients registered in the Norwegian Renal Registry with transplan more than 10 years ago.

Description

Inclusion Criteria:

  • Registered in the Norwegian Renal Registry
  • Documented elevated iPTH at Tx and 10 weeks post-tx
  • Well functioning transplant 10 years following tx
  • Signed informed consent

Exclusion Criteria:

  • Lack of ability to comply with the protocol
  • Refused written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
eGFR >=60ml/min/1.73m2
Patients with an estimated glomerular filtration rate of >=60 ml/min/1.73m2.
eGFR 45-60ml/min/1.73m2
Patients with estimated glomerular filtration rate >=45 ml/min/1.73m2 and <60ml/min/1.73m2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibroblast growth factor 23 (FGF23)
Time Frame: More than 10 years after successful renal transplantation
To evaluate the long-term effect of a successful renal transplant on this biomarker.
More than 10 years after successful renal transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intact parathyroid hormone (iPTH)
Time Frame: More than 10 years after successful renal transplantation
To evaluate the long-term effect of a successful renal transplant on this biomarker.
More than 10 years after successful renal transplantation
Klotho
Time Frame: More than 10 years after successful renal transplantation
To evaluate the long-term effect of a successful renal transplant on this biomarker.
More than 10 years after successful renal transplantation
Neutrophil gelatinase-associated lipocalin (NGAL)
Time Frame: More than 10 years after successful renal transplantation
To evaluate the long-term effect of a successful renal transplant on this biomarker.
More than 10 years after successful renal transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Investigators

  • Principal Investigator: Inger Hjørdis Bleskestad, MD, Helse Stavanger HF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

November 8, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (Estimate)

November 16, 2012

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REK2010/2926

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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