The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23

May 1, 2013 updated by: Camillians Saint Mary's Hospital Luodong

Compared the Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 With Calcium Carbonate in Hemodialysis Patients

To compare the effect of lanthanum carbonate with calcium carbonate on serum FGF23 levels in hemodialysis patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators enrolled patients on maintenance hemodialysis and randomized them to two groups. One group will receive lanthanum carbonate and another group will receive calcium carbonate. The investigators will compare serum FGF23 levels between two groups after they receive above medication for 6 months.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Lanthanum carbonate
Lanthanum carbonate 375mg~750 mg tid for 6 months
Drug: Lanthanum carbonate
the effect on serum FGF23
Other Names:
  • Fosrenol
ACTIVE_COMPARATOR: Calcium carbonate
Calcium carbonate 500mg~1000 mg tid for 6 months
Drug: Calcium Carbonate
Calcium carbonate 500mg~1000 mg tid for 6 months
Other Names:
  • TOP-CAL(CaCO3)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum level of fibroblast growth factor
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Camillians Saint Mary's Hospital Luodong

Investigators

  • Principal Investigator: Shih-Ching Tsai, MD, Saint Mary's hospital-Lotung

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ANTICIPATED)

July 1, 2014

Study Completion (ANTICIPATED)

July 1, 2014

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

May 1, 2013

First Posted (ESTIMATE)

May 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 1, 2013

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMHLANFGF23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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