MedTrace Logo

Study Comparing Effects of Lanthanum Carbonate Versus Calcium Acetate Versus Dietary Phosphorus Restriction

NCT01357317 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-06-12

No results posted yet for this study

Summary

Objective: To examine the effects of three commonly applied treatments of disordered phosphorus homeostasis on biochemical markers and vascular characteristics in patients with moderate and advanced non-dialysis dependent chronic kidney disease.

Conditions

Interventions

OTHER

Diet counseling

If serum phosphorus level exceeds 4.6 mg/dl in the lanthanum carbonate arm in spite of consecutive up-titration of the medical dose or due to patients' intolerance of the medication, patient will be considered a treatment failure and other treatment options will be implemented, including diet counseling or another class of phosphorus binder (in this order of preference).

OTHER

Diet counseling

If serum phosphorus level exceeds 4.6 mg/dl in spite of consecutive up-titration of the medication dose or due to patients' intolerance of the medication, patient will be considered a treatment failure and other treatment options will be implemented, including diet counseling or another class of phosphorus binder (in this order of preference).

DRUG

Phosphorus binder

If serum phosphorus level exceeds 4.6 mg/dl after 3 months of concerted efforts, the patient will be considered a treatment failure and treatment with a phosphorus binder of the treating physician's choice will be allowed.

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • Salem Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Csaba P. Kovesdy, M.D. · Salem VAMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-10-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01357317 on ClinicalTrials.gov