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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Ramathibodi Hospital
ClinicalTrials.gov Identifier:
NCT00903578
First received: May 1, 2009
Last updated: December 16, 2009
Last verified: December 2009
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sinee Disthabanchong, M.D, Ramathibodi Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT00903578     History of Changes
Other Study ID Numbers: KT-1
Study First Received: May 1, 2009
Last Updated: December 16, 2009
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on November 19, 2014