Impact of Fibroblast Growth Factor 23 (FGF-23) and Serum Phosphate on Allograft Function and Mortality in Kidney Allograft Recipients

December 16, 2009 updated by: Ramathibodi Hospital

Impact of FGF-23 and Serum Phosphate on Allograft Function and Mortality in Kidney Allograft Recipients

The present study will examine whether serum FGF-23 and serum phosphate at baseline of kidney transplant recipients can predict progression of allograft dysfunction at 3 years and all-cause mortality at 5 years.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

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

  • Thailand
    • Bangkok
      • Phayathai, Bangkok, Thailand, 10400
        • Ramathibodi Hospital, Mahidol University

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

Kidney transplant recipients

Description

Inclusion Criteria:

  • at least one year post-transplantation
  • no more than 10% increase in serum creatinine for the past 3 months

Exclusion Criteria:

  • refuse to participate in the study
  • any acute illnesses

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
Kidney transplant recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression of allograft dysfunction and all-cause Mortality
Time Frame: 3 and 5 years
3 and 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Relationship of FGF-23 and 25-OH-D, 1-25-OH-D, PTH, calcium, phosphate, urine phosphate and eGFR
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Ramathibodi Hospital

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

May 1, 2009

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

May 1, 2009

First Submitted That Met QC Criteria

May 15, 2009

First Posted (Estimate)

May 18, 2009

Study Record Updates

Last Update Posted (Estimate)

December 17, 2009

Last Update Submitted That Met QC Criteria

December 16, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KT-1

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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