NCT03367338

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

January 3, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2018

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

4 months

First QC Date

December 5, 2017

Last Update Submit

September 29, 2018

Conditions

Chronic Kidney Disease Requiring Chronic DialysisHyperphosphatemiaDietary InterventionElevated Fibroblast Growth Factor-23

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Difference in change-from-baseline serum phosphate

    2 days

  • Difference in change-from-baseline intact parathyroid hormone

    2 days

  • Difference in change-from-baseline C-terminal FGF23

    2 days

Study Arms (2)

Group A

ACTIVE COMPARATOR

Participants in group A consumed a 2-day very low-phosphate diet with PPR of 8 mg/g, followed by a 5-day washout period in which they adhered to usual diets, and then consumed a 2-day low-phosphate diet with PPR of 10 mg/g.

Other: Low-phosphate diet

Group B

ACTIVE COMPARATOR

Compared with group A, the opposite order of low-phosphate diets will be prescribed in group B.

Other: Low-phosphate diet

Interventions

Low-phosphate dietOTHER

Very low-phosphate diet, PPR value of 8 mg/g, vs. low-phosphate diet, PPR value of 10 mg/g

Group AGroup B

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%)

You may not qualify if:

  • Subjects with serum albumin less than 2.5 g/dL, having psychiatric disorders, mental retardation or poor adherence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Location

Related Publications (4)

  • 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, Pavenstadt 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.

    PMID: 26437603BACKGROUND

  • Isakova T, Gutierrez OM, Smith K, Epstein M, Keating LK, Juppner 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.

    PMID: 20631407BACKGROUND

  • 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.

    PMID: 22362063BACKGROUND

  • 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 Nov 1;33(11):1977-1983. doi: 10.1093/ndt/gfy005.

    PMID: 29420827BACKGROUND

MeSH Terms

Conditions

Hyperphosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wan-Chuan Tsai

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

December 5, 2017

First Posted

December 8, 2017

Study Start

January 3, 2018

Primary Completion

May 1, 2018

Study Completion

June 8, 2018

Last Updated

October 2, 2018

Record last verified: 2018-09

Locations

TW(1)