Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477516
Status:
COMPLETED
Last Update Posted:
2012-06-15
First Post:
2007-05-21
Brief Title:
Association of FGF-23 and Parathyroid Hormone PTH in Dialysis Patients
Sponsor:
James B Wetmore MD
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Determination of FDF-23 Levels in Non-suppressible PTH Secretion and the Influence of Inflammation on Fetuin A Levels During Hemodialysis Treatment
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine how levels of this newly-discovered hormone called FGF-23 changes in the blood in response to a high calcium dialysis bath during a hemodialysis HD treatment and how this relates to changes in the calcium and PTH levels We are also studying the effects of dialysis and inflammation on the levels of Fetuin A
We intend to prospectively study a cohort of end stage renal disease ESRD patients on hemodialysis in order to determine whether FDF-23 levels independently affect non-suppressible PTH levels The relationship between Fetuin A and inflammatory markers will also be determined By dialyzing patients on 35 mEqL calcium dialysate bath we seek any relationship between ionized calcium FGF-23 and PTH
We intend to prospectively study a cohort of end stage renal disease ESRD patients on hemodialysis in order to determine whether FDF-23 levels independently affect non-suppressible PTH levels The relationship between Fetuin A and inflammatory markers will also be determined By dialyzing patients on 35 mEqL calcium dialysate bath we seek any relationship between ionized calcium FGF-23 and PTH
Detailed Description:
The goal of this study is to ascertain whether there is a regulatory relationship between the novel phosphorus-regulating polypeptide fibroblast growth factor-23 FGF-23 ionized calcium iCa and parathyroid hormone PTH levels In addition we will determine if there is an inverse relationship between Fetuin A levels and inflammatory markers interleukin 6 IL-6 and C-reactive protein CRP during a hemodialysis treatment
All patients participating in this study will be off Zemplar andor Sensipar for a washout period of approximately 4 weeks as these medications will interfere with the study Patients will go through one designated research hemodialysis time for a blood draw Blood draws will be taken during 4 separate intervals at 0 45 90 and 150 minutes At each interval 4 tubes of blood will be drawn
There are no further required blood draws once each designated research HD session has been completed At the conclusion of the designated research HD session vitamin D analogue Zemplar andor Cinacalcet Sensipar will be restarted and the dose will be adjusted to reflect the subjects recent biochemical markers Ca Phos and iPTH
All patients participating in this study will be off Zemplar andor Sensipar for a washout period of approximately 4 weeks as these medications will interfere with the study Patients will go through one designated research hemodialysis time for a blood draw Blood draws will be taken during 4 separate intervals at 0 45 90 and 150 minutes At each interval 4 tubes of blood will be drawn
There are no further required blood draws once each designated research HD session has been completed At the conclusion of the designated research HD session vitamin D analogue Zemplar andor Cinacalcet Sensipar will be restarted and the dose will be adjusted to reflect the subjects recent biochemical markers Ca Phos and iPTH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None