Association of FGF-23 and Parathyroid Hormone (PTH) in Dialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James B. Wetmore, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00477516
First received: May 21, 2007
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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 3.5 mEq/L calcium dialysate bath, we seek any relationship between ionized calcium, FGF-23 and PTH.


Condition Intervention
End-Stage Renal Disease
Procedure: exposure to a high-calcium dialysate bath

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Determination of FDF-23 Levels in Non-suppressible PTH Secretion and the Influence of Inflammation on Fetuin A Levels During Hemodialysis Treatment

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • change in serum fibroblast growth factor-23 (FGF-23) [ Time Frame: 0, 45, 90, and 150 minutes ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: January 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: exposure to a high-calcium dialysate bath
Subjects are exposed to a high calcium (3.5 mEq/L) dialysate bath for 150 minutes (part 1). At defined timepoints (0, 45, 90, and 150 min) blood is sampled for calcium, PTH, phosphorous, and FGF-23. At another (later) dialysis session (part 2), the process is repeated except that the subjects are exposed to a normal calcium bath (2.5 mEq/L). For each subject, results from part 1 are compared to the results from part 2.

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 and/or 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®) and/or Cinacalcet (Sensipar®) will be restarted, and the dose will be adjusted to reflect the subject's recent biochemical markers (Ca, Phos, and iPTH).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Chronic Hemodialysis for more than 3 months
  • iPTH levels ≥ 300 pg/ml in the absence of therapy: Cinacalcet (Sensipar ®) and/or 1,25 Vitamin analogues (Zemplar®)
  • Corrected Ca ≥ 8.4 mg/dl at time of enrollment
  • Ability to stay at least 3 hours during hemodialysis treatment

Exclusion Criteria:

  • Pediatric Patients (age ≤ 18 years)
  • Those unable to give informed consent
  • Dialysis treatment for less than 3 months, or pre-emptive kidney transplantation
  • Inability to stay more than 3 hours during a single hemodialysis treatment period
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00477516

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
James B. Wetmore, MD
Investigators
Principal Investigator: Peter W. Santos, D.O University of Kansas
Principal Investigator: James B. Wetmore, M.D. University of Kansas
  More Information

No publications provided

Responsible Party: James B. Wetmore, MD, Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00477516     History of Changes
Other Study ID Numbers: 10571
Study First Received: May 21, 2007
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Dialysis Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014