Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients

NCT ID: NCT01755078

Last Updated: 2014-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-06-30

Brief Summary

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The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis patients to achieve full-scale of medical care, including reduction of atherosclerotic risk factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.

Detailed Description

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Conditions

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Hemodialysis Hyperphosphatemia Cardiovascular Events

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sevelamer HCl

Sevelamer HCl regular treatment 1-3 tablets TID

Group Type EXPERIMENTAL

Sevelamer HCl

Intervention Type DRUG

Non-metal phosphate binder

Calcium-based binder

Calcium-based phosphate binder (either CaCO3 or Ca acetate) administered 1-3 tablets TID

Group Type ACTIVE_COMPARATOR

Calcium-based phosphate binder

Intervention Type DRUG

Interventions

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Sevelamer HCl

Non-metal phosphate binder

Intervention Type DRUG

Calcium-based phosphate binder

Intervention Type DRUG

Other Intervention Names

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Renagel Tablets Calcium carbonate Calcium acetate

Eligibility Criteria

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Inclusion Criteria

* Males or females aged between 18-70 years old
* Subject with hyperphosphatemia (5.5 - 8.5 mg/dL) at both WK(-2) and WK0
* On stable TIW hemodialysis for 3 months or longer

Exclusion Criteria

* Patients with hypercalcemia (corrected serum calcium \> 10.5 mg/dL)
* Any of the following abnormalities: ALT or AST \> 3X ULN; iPTH \> 1000 or \< 150 pg/mL
* History of dysphagia or swallowing disorders
* History of GI motility disorder or GI bleeding within 3 months prior to entry
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chugai Pharma Taiwan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chiu-Ching Huang, Professor

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

References

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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.

Reference Type DERIVED
PMID: 40576086 (View on PubMed)

Lin HH, Liou HH, Wu MS, Huang CC. Factors associated with serum fetuin-A concentrations after long-term use of different phosphate binders in hemodialysis patients. BMC Nephrol. 2016 Mar 23;17:33. doi: 10.1186/s12882-016-0245-3.

Reference Type DERIVED
PMID: 27007989 (View on PubMed)

Other Identifiers

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CPT-REN-002

Identifier Type: -

Identifier Source: org_study_id

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