RecruitingACTRN12606000380594

An Open Label, Dose Titration Study Of Sevelamer Carbonate Dosed Three Times A Day In Hyperphosphatemic Chronic Kidney Disease (CKD) Patients Not On Dialysis

An Open Label, Dose Titration Study of Sevelamer Carbonate dosed Three Times A Day in the control of phosphorus levels in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis


Sponsor

Genzyme Corporation, USA

Enrollment

40 participants

Start Date

Jan 1, 2006

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a medication called sevelamer carbonate in people with chronic kidney disease (CKD) who are not on dialysis and have high phosphate levels in their blood (a condition called hyperphosphatemia). When kidneys are not working properly, phosphate can build up in the blood, which over time damages blood vessels and bones. Sevelamer carbonate is a pill that binds phosphate in the gut and helps remove it from the body. The study aims to find the right dose by starting low and adjusting upward (dose titration) over time. You may be eligible if: - You have chronic kidney disease and are not on dialysis - You have confirmed high phosphate levels (hyperphosphatemia) either without a phosphate binder or after stopping your current one - You are able to give written informed consent You may NOT be eligible if: - You have a known allergy to sevelamer carbonate or any part of the study medication - You have a bowel obstruction, difficulty swallowing, or a severe gut motility problem - You have poorly controlled diabetes, poorly controlled high blood pressure, active vasculitis, or HIV - You are pregnant or breastfeeding - You have active cancer (except for minor skin cancer) - You are unable to comply with study requirements Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This study will test an 8-week treatment course of the investigational drug Sevelamer Carbonate, at doses from 4.8g up to 12g orally daily, in patients with Hyperphosphatemic CKD not on dialysis.

This study will test an 8-week treatment course of the investigational drug Sevelamer Carbonate, at doses from 4.8g up to 12g orally daily, in patients with Hyperphosphatemic CKD not on dialysis.


Locations(1)

United Kingdom

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ACTRN12606000380594