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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Ramathibodi Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00903578
First Posted: May 18, 2009
Last Update Posted: December 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ramathibodi Hospital
  Purpose
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
Kidney Transplantation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Impact of FGF-23 and Serum Phosphate on Allograft Function and Mortality in Kidney Allograft Recipients

Resource links provided by NLM:


Further study details as provided by Ramathibodi Hospital:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: May 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Kidney transplant recipients

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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

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