Hyperphosphatemia Clinical Trial
Official title:
The Effect of Low-Phosphate Diet on Fibroblast Growth Factor-23 Level in Patients Undergoing Hemodialysis
Verified date | September 2018 |
Source | Far Eastern Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aims of the study are to evaluate the effect of low-phosphate diet on FGF23 level and to determine the optimal amount of dietary phosphate restriction in hemodialysis patients. In particular, the investigators will assess the comparing effect of pre-specified low-phosphate diets, very low-phosphate diet, phosphate-to-protein ratio (PPR) value of 8 mg/g, versus low-phosphate diet, PPR value of 10 mg/g, on the change of FGF23 and phosphate level.
Status | Completed |
Enrollment | 35 |
Est. completion date | June 8, 2018 |
Est. primary completion date | May 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Subjects with end-stage kidney disease undergoing thrice-weekly hemodialysis for more than three months, the most recent serum phosphate level greater than 5.5 mg/dL or between 3.5 and 5.5 mg/dL with regular phosphate binder use, and having adequate dialysis (urea reduction ratio equal to or greater than 65%) Exclusion Criteria: - Subjects with serum albumin less than 2.5 g/dL, having psychiatric disorders, mental retardation or poor adherence |
Country | Name | City | State |
---|---|---|---|
Taiwan | Far Eastern Memorial Hospital | New Taipei City |
Lead Sponsor | Collaborator |
---|---|
Wan-Chuan Tsai |
Taiwan,
Di Iorio B, Di Micco L, Torraca S, Sirico ML, Russo L, Pota A, Mirenghi F, Russo D. Acute effects of very-low-protein diet on FGF23 levels: a randomized study. Clin J Am Soc Nephrol. 2012 Apr;7(4):581-7. doi: 10.2215/CJN.07640711. Epub 2012 Feb 23. Erratum in: Clin J Am Soc Nephrol. 2012 Aug;7(8):1369. — View Citation
Grabner A, Amaral AP, Schramm K, Singh S, Sloan A, Yanucil C, Li J, Shehadeh LA, Hare JM, David V, Martin A, Fornoni A, Di Marco GS, Kentrup D, Reuter S, Mayer AB, Pavenstädt H, Stypmann J, Kuhn C, Hille S, Frey N, Leifheit-Nestler M, Richter B, Haffner D, Abraham R, Bange J, Sperl B, Ullrich A, Brand M, Wolf M, Faul C. Activation of Cardiac Fibroblast Growth Factor Receptor 4 Causes Left Ventricular Hypertrophy. Cell Metab. 2015 Dec 1;22(6):1020-32. doi: 10.1016/j.cmet.2015.09.002. Epub 2015 Oct 1. — View Citation
Isakova T, Gutiérrez OM, Smith K, Epstein M, Keating LK, Jüppner H, Wolf M. Pilot study of dietary phosphorus restriction and phosphorus binders to target fibroblast growth factor 23 in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Feb;26(2):584-91. doi: 10.1093/ndt/gfq419. Epub 2010 Jul 14. — View Citation
Tsai WC, Wu HY, Peng YS, Hsu SP, Chiu YL, Chen HY, Yang JY, Ko MJ, Pai MF, Tu YK, Hung KY, Chien KL. Effects of lower versus higher phosphate diets on fibroblast growth factor-23 levels in patients with chronic kidney disease: a systematic review and meta-analysis. Nephrol Dial Transplant. 2018 Feb 6. doi: 10.1093/ndt/gfy005. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in change-from-baseline intact FGF-23 | Difference in change-from-baseline intact FGF-23 level between two low-phosphate diets, very low-phosphate diet, PPR value of 8 mg/g, with low-phosphate diet, PPR value of 10 mg/g | 2 days | |
Secondary | Difference in change-from-baseline serum phosphate | Difference in change-from-baseline serum phosphate level between two low-phosphate diets, very low-phosphate diet, PPR value of 8 mg/g, with low-phosphate diet, PPR value of 10 mg/g | 2 days | |
Secondary | Difference in change-from-baseline intact parathyroid hormone | Difference in change-from-baseline intact parathyroid hormone level between two low-phosphate diets, very low-phosphate diet, PPR value of 8 mg/g, with low-phosphate diet, PPR value of 10 mg/g | 2 days | |
Secondary | Difference in change-from-baseline C-terminal FGF23 | Difference in change-from-baseline C-terminal FGF23 level between two low-phosphate diets, very low-phosphate diet, PPR value of 8 mg/g, with low-phosphate diet, PPR value of 10 mg/g | 2 days |
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