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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT02237534 -
Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia
|
Phase 4 | |
Unknown status |
NCT01245517 -
The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient
|
N/A | |
Completed |
NCT01187628 -
Long-term Study in Chronic Kidney Disease (Extension From Study 14817)
|
Phase 3 | |
Completed |
NCT01252771 -
Phosphate Kinetic Modeling 2
|
Phase 4 | |
Completed |
NCT00506441 -
A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
|
Phase 3 | |
Recruiting |
NCT04440696 -
To Evaluate the Patient Tolerance, Pharmacodynamics and Pharmacokinetics of Lanthanum Polystyrene Sulfonate Powder
|
Phase 1/Phase 2 | |
Completed |
NCT01976572 -
Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01742585 -
A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
|
Phase 3 | |
Completed |
NCT01191255 -
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
|
Phase 3 | |
Completed |
NCT01003223 -
Phosphate Kinetic Modeling
|
N/A | |
Completed |
NCT00505037 -
A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
|
Phase 2 | |
Completed |
NCT00508885 -
The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
|
Phase 1/Phase 2 | |
Completed |
NCT04551300 -
A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients
|
Phase 2 | |
Completed |
NCT01955876 -
Fosrenol Post-marketing Surveillance in Japan
|
N/A | |
Completed |
NCT04579315 -
Long-term Effects of the New Nordic Renal Diet in Patients With Moderate Chronic Kidney Disease
|
N/A | |
Completed |
NCT03861247 -
Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients
|
Phase 3 | |
Terminated |
NCT01725113 -
Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
|
Phase 4 | |
Recruiting |
NCT01238588 -
The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan
|
N/A | |
Completed |
NCT00542815 -
A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
|
Phase 3 | |
Completed |
NCT04549597 -
Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia
|
Phase 4 |