Fibroblast Growth Factor-23 (FGF23) Reduction in Predialysis Chronic Kidney Disease (CKD)
Fibroblast Growth Factor-23 Reduction in Predialysis Chronic Kidney Disease
2 other identifiers
interventional
43
1 country
1
Brief Summary
The investigators would like to study the role of phosphorus metabolism in the development of certain hormonal problems in people with chronic kidney disease (CKD). More specifically, the goals of the research are (1) to understand the cause of hyperparathyroidism - a hormone problem that often develops in patients who have kidney disease and (2) to test whether decreasing phosphorus intake could help improve or prevent hyperparathyroidism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2009
CompletedFirst Posted
Study publicly available on registry
February 13, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
June 7, 2013
CompletedJune 7, 2013
May 1, 2013
2.6 years
February 12, 2009
February 7, 2013
May 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels
Nonfasting blood was assessed over a period of 12 weeks. The primary endpoint was percentage change in FGF-23 levels from baseline.
Week 0 - 12
Percentage Changes in Parathyroid Hormone (PTH) Levels
Nonfasting blood was assessed over a period of 12 weeks. Endpoint was percentage changes in PTH levels from baseline.
Week 0 - 12
Study Arms (4)
900 mg Phosphate Diet-LC
ACTIVE COMPARATORdietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
Ad Libitum Diet-LC
ACTIVE COMPARATORno dietary intervention + phosphorus binder (Lanthanum Carbonate)
900 mg Phosphate Diet-LC Placebo
ACTIVE COMPARATORdietary phosphorus restriction (900 mg/day of phosphorus) + placebo
Ad Libitum Diet-LC Placebo
PLACEBO COMPARATORno dietary intervention + placebo
Interventions
Phosphorus binder
Amount of phosphorus consumption in a day kept below 900 mg.
Placebo for Lanthanum Carbonate
Patients continued to eat their usual diet.
Eligibility Criteria
You may qualify if:
- We will include stage 3a, 3b and 4 CKD patients, aged 18 years or over with normal serum phosphate levels (≤ 4.6 mg/dl)
You may not qualify if:
- Patients with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period
- Patients expected to require dialysis initiation within the follow up period
- Patients with hyperphosphatemia \> 4.6 mg/dl
- Patients with any previous or current treatment with phosphate binders or active vitamin D (doxercalciferol or calcitriol)
- Malnutrition, defined as a serum albumin \< 3.0 mg/dl
- Patients with liver disease (ALT or AST \> 100 U/L) or cholestasis (direct bilirubin \> 1.0 mg/dl) because this can limit their ability to absorb fat soluble vitamins such as vitamin D
- Anemia, defined as a hematocrit \< 27% at the screening visit
- Medical conditions impacting Pi metabolism-primary hyper- or hypoparathyroidism; Patients with previous subtotal parathyroidectomy; gastrointestinal malabsorption disorders such as Crohn's Disease, ulcerative colitis, celiac disease, or severe liver dysfunction;
- Patients with outpatient counseling by a renal nutritionist within the previous 6 months
- Hospitalization within the previous 4 weeks
- Pregnancy or breastfeeding mothers
- Patients unable to independently provide written informed consent - prisoners, mentally incompetent, minors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami Hospital
Miami, Florida, 33136, United States
Related Publications (2)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVEDIsakova T, Barchi-Chung A, Enfield G, Smith K, Vargas G, Houston J, Xie H, Wahl P, Schiavenato E, Dosch A, Gutierrez OM, Diego J, Lenz O, Contreras G, Mendez A, Weiner RB, Wolf M. Effects of dietary phosphate restriction and phosphate binders on FGF23 levels in CKD. Clin J Am Soc Nephrol. 2013 Jun;8(6):1009-18. doi: 10.2215/CJN.09250912. Epub 2013 Mar 7.
PMID: 23471131DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Myles Wolf, Associate Professor of Medicine, Chief-Division of Nephrology and Hypertension
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Myles Wolf, MD, MMSc
University of Miami
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Medicine, Chief of Division of Nephrology and Hypertension
Study Record Dates
First Submitted
February 12, 2009
First Posted
February 13, 2009
Study Start
July 1, 2009
Primary Completion
February 1, 2012
Study Completion
March 1, 2012
Last Updated
June 7, 2013
Results First Posted
June 7, 2013
Record last verified: 2013-05