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

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ClinicalTrials.gov Identifier: NCT00903578
Recruitment Status : Unknown
Verified December 2009 by Ramathibodi Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 18, 2009
Last Update Posted : December 17, 2009
Sponsor:
Information provided by:
Ramathibodi Hospital

Brief Summary:
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.

Condition or disease
Kidney Transplantation

Study Type : Observational
Estimated Enrollment : 200 participants
Time Perspective: Prospective
Official Title: Impact of FGF-23 and Serum Phosphate on Allograft Function and Mortality in Kidney Allograft Recipients
Study Start Date : May 2009
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Kidney transplant recipients



Primary Outcome Measures :
  1. Progression of allograft dysfunction and all-cause Mortality [ Time Frame: 3 and 5 years ]

Secondary Outcome Measures :
  1. Relationship of FGF-23 and 25-OH-D, 1-25-OH-D, PTH, calcium, phosphate, urine phosphate and eGFR [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
serum


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Kidney transplant recipients
Criteria

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

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): NCT00903578


Locations
Thailand
Ramathibodi Hospital, Mahidol University
Phayathai, Bangkok, Thailand, 10400
Sponsors and Collaborators
Ramathibodi Hospital
Investigators
Principal Investigator: Sinee Disthabanchong, M.D. Ramathibodi Hospital, Mahidol University

Responsible Party: Sinee Disthabanchong, M.D, Ramathibodi Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT00903578     History of Changes
Other Study ID Numbers: KT-1
First Posted: May 18, 2009    Key Record Dates
Last Update Posted: December 17, 2009
Last Verified: December 2009

Keywords provided by Ramathibodi Hospital:
FGF-23
vitamin D
phosphate
allograft dysfunction
mortality