The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23
Compared the Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 With Calcium Carbonate in Hemodialysis Patients
1 other identifier
interventional
30
1 country
1
Brief Summary
To compare the effect of lanthanum carbonate with calcium carbonate on serum FGF23 levels in hemodialysis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2011
Typical duration for phase_4
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
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 24, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMay 3, 2013
August 1, 2011
2.9 years
April 24, 2013
May 1, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
serum level of fibroblast growth factor
6 months
Study Arms (2)
Lanthanum carbonate
ACTIVE COMPARATORLanthanum carbonate 375mg\~750 mg tid for 6 months
Calcium carbonate
ACTIVE COMPARATORCalcium carbonate 500mg\~1000 mg tid for 6 months
Interventions
Calcium carbonate 500mg\~1000 mg tid for 6 months
Eligibility Criteria
You may qualify if:
- Age \> 18 years old
- Chronic renal failure on maintenance hemodialysis 3 times a week for at least 3 months Serum calcium:8-10.5 mg/dL
- Serum phosphate:3.5-6 mg/dL(before washout period)
- Serum phosphate ≧6 mg/dL after washout period
- Serum i-PTH: 150-600 pg/mL
You may not qualify if:
- Diabetes mellitus
- Post parathyroidectomy
- Life expectancy\< 6 months
- Liver disease(hepatitis B,C or liver dysfunction)
- Severe gastrointestinal disorders or other severe comorbidity
- Poor compliance
- Intolerance to lanthanum or calcium carbonate
- Active infection
- Malnutrition(serum albumin\<3 g/dL or clinical assessment)
- Kt/V\< 1.2 (inadequate dialysis)
- Serum phosphate\>7.5 mg/dL after washout period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Mary's hospital-Lotung
Taipei, 265, Taiwan
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: 40576086DERIVEDChang YM, Tsai SC, Shiao CC, Liou HH, Yang CL, Tung NY, Hsu KS, Chen IL, Liu MC, Kao JL, Jhen RN, Huang YT. Effects of lanthanum carbonate and calcium carbonate on fibroblast growth factor 23 and hepcidin levels in chronic hemodialysis patients. Clin Exp Nephrol. 2017 Oct;21(5):908-916. doi: 10.1007/s10157-016-1362-9. Epub 2016 Dec 7.
PMID: 27928636DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shih-Ching Tsai, MD
Saint Mary's hospital-Lotung
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2013
First Posted
May 3, 2013
Study Start
August 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
May 3, 2013
Record last verified: 2011-08