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Trial record 25 of 109 for:    CALCIUM CATION

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00477516
Recruitment Status : Completed
First Posted : May 23, 2007
Last Update Posted : June 15, 2012
Information provided by (Responsible Party):
James B. Wetmore, MD, University of Kansas Medical Center

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

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Procedure: exposure to a high-calcium dialysate bath Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. change in serum fibroblast growth factor-23 (FGF-23) [ Time Frame: 0, 45, 90, and 150 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00477516

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

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Responsible Party: James B. Wetmore, MD, Associate Professor, University of Kansas Medical Center Identifier: NCT00477516     History of Changes
Other Study ID Numbers: 10571
First Posted: May 23, 2007    Key Record Dates
Last Update Posted: June 15, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Calcium, Dietary
Calcium-Regulating Hormones and Agents
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Dialysis Solutions
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmaceutical Solutions