Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis

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

PHASE3

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-09-30

Brief Summary

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The study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients on dialysis.

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Detailed Description

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Conditions

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Chronic Kidney Disease Chronic Kidney Disease on Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sevelamer carbonate

Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (\>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site.

Group Type EXPERIMENTAL

Sevelamer carbonate

Intervention Type DRUG

* Starting dose 1 tablet (800 mg), three times per day (2.4 g/day) with meals.
* If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet(800mg).Three times daily with meals.

Placebo

Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (\>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

* Starting dose of 1 tablet (800mg), three times per day (2.4g/day)with meals.
* If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet (800 mg). Three times daily with meals.

Interventions

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Placebo

* Starting dose of 1 tablet (800mg), three times per day (2.4g/day)with meals.
* If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet (800 mg). Three times daily with meals.

Intervention Type DRUG

Sevelamer carbonate

* Starting dose 1 tablet (800 mg), three times per day (2.4 g/day) with meals.
* If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet(800mg).Three times daily with meals.

Intervention Type DRUG

Other Intervention Names

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Renvela

Eligibility Criteria

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Inclusion Criteria

* On hemodialysis regimen scheduled for four hour duration three times per week for a minimum 30 days prior to Visit 1 and throughout the study
* Have a central laboratory serum iPTH measurement less than 1000 pg/mL at Visit 1
* Have a central laboratory serum phosphorus measurement greater than 5.5 mg/dL at Visit 1a

Exclusion Criteria

* Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal (GI) motility disorders including severe constipation
* Documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any clinically significant unstable medical condition

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No