MedTrace Logo

A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

NCT01039428 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2015-09-14

Study results available
· View outcomes & findings →

Summary

This was a study to evaluate the efficacy and safety of HS219, chitosan-loaded chewing gum, when given three times a day for 3 weeks to the hemodialysis (HD) patients with hyperphosphatemia whose serum inorganic phosphorus was not well controlled with calcium carbonate or sevelamer hydrogen chloride.

Conditions

Interventions

DIETARY_SUPPLEMENT

HS219

Chewing for 30 min three time a day far after meal

DIETARY_SUPPLEMENT

Placebo

Chewing for 30 min three times a day far after meal

Sponsors & Collaborators

  • KDL Inc.

    lead INDUSTRY

Principal Investigators

  • Tadao Akizawa, MD · Divison of Nephrology, Department of Medicine, Showa University School of Medicine

  • Masafumi Fukagawa, MD, PhD · Divison of Nephrology and Metabolism, Tokai University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-05-31
Completion
2010-06-30

Countries

  • Japan

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 NCT01039428 on ClinicalTrials.gov