Impact of Fibroblast Growth Factor 23 (FGF-23) and Serum... | NCT00903578

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

NCT00903578

Sponsor

Ramathibodi Hospital

Status

Unknown status

Last Update Posted

Dec 17, 2009Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Kidney Transplantation

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jan 2015Estimated

Completion Date

Jan 2015Estimated

First Submitted Date

May 1, 2009

First Submission Date that Met QC Criteria

May 15, 2009

First Posted Date

May 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2009

Last Update Posted Date

Dec 17, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Kidney transplant recipients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Kidney transplant recipients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sinee Disthabanchong, M.D.	Ramathibodi Hospital, Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ramathibodi Hospital, Mahidol University		Phayathai	Bangkok	10400	Thailand