Association of FGF-23 and Parathyroid Hormone (PTH) in Dialysis Patients
Determination of FDF-23 Levels in Non-suppressible PTH Secretion and the Influence of Inflammation on Fetuin A Levels During Hemodialysis Treatment
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- University of Kansas Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 1
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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change in serum fibroblast growth factor-23 (FGF-23)
Tidsramme: 0, 45, 90, and 150 minutes
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0, 45, 90, and 150 minutes
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Peter W. Santos, D.O, University of Kansas Medical Center
- Hovedetterforsker: James B. Wetmore, M.D., University of Kansas Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10571
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