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

NCT00477516 | Completed

• 1 other identifier: 10571
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

End-Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• change in serum fibroblast growth factor-23 (FGF-23)

  0, 45, 90, and 150 minutes

Study Arms (1)

1

EXPERIMENTAL

Procedure: exposure to a high-calcium dialysate bath

Interventions

exposure to a high-calcium dialysate bath PROCEDURE

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• James B. Wetmore, MD: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter W. Santos, D.O

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• James B. Wetmore, M.D.

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 21, 2007
• First Posted: May 23, 2007
• Study Start: January 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: June 15, 2012

Record last verified: 2012-06

Locations

US (1)