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

This study is currently recruiting participants.

Verified by Ramathibodi Hospital, May 2009

First Received: May 1, 2009 Last Updated: May 15, 2009 History of Changes

Sponsored by:	Ramathibodi Hospital
Information provided by:	Ramathibodi Hospital
ClinicalTrials.gov Identifier:	NCT00903578

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:	Prospective
Official Title:	Impact of FGF-23 and Serum Phosphate on Allograft Function and Mortality in Kidney Allograft Recipients

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

U.S. FDA Resources

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

Biospecimen Description:

serum

Estimated Enrollment:	200
Study Start Date:	May 2009
Estimated Study Completion Date:	May 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903578

Contacts

Contact: Sinee Disthabanchong, M.D.	+6622011116	sineemd@hotmail.com
Contact: Supinda Sirilak, M.D.	+6622011116	asupindasirilak@gmail.com

Locations

Thailand, Bangkok
Ramathibodi Hospital, Mahidol University	Recruiting
Phayathai, Bangkok, Thailand, 10400
Contact: Sinee Disthabanchong, MD +6622011116 tesdb@mahidol.ac.th
Contact: Supinda Sirilak, MD +6622011116 asupindasirilak@gmail.com

Sponsors and Collaborators

Ramathibodi Hospital

Investigators

Principal Investigator:

Sinee Disthabanchong, M.D.

Ramathibodi Hospital, Mahidol University

More Information

No publications provided

Responsible Party:	Ramathibodi Hospital, Mahidol University ( Sinee Disthabanchong, M.D )
Study ID Numbers:	KT-1
Study First Received:	May 1, 2009
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00903578 History of Changes
Health Authority:	Thailand: Ethical Committee

Keywords provided by Ramathibodi Hospital:

FGF-23
vitamin D
phosphate
allograft dysfunction
mortality

Study placed in the following topic categories:

Vitamin D
Vitamins
Mitogens

ClinicalTrials.gov processed this record on September 10, 2009