A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis

A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease (CKD) Patients Not on Dialysis

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00833768

Acronym

ASPIRE

Enrollment

Registered

2009-02-02

Start date

2009-01-31

Completion date

2009-09-30

Last updated

2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Hyperphosphatemia

Brief summary

Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.

Interventions

DRUGSevelamer carbonate

800mg tablets to be taken orally with meals three times per day

DRUGPlacebo for sevelamer carbonate

Placebo tablets to be taken orally with meals three times per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Serum phosphorus measurement ≥4.6 mg/dL (≥1.49 mmol/L) and ≤5.5 mg/dL (≤1.76 mmol/L after discontinuation of current phosphate binder therapy if applicable.

Exclusion criteria

* Active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels	24 weeks

Secondary

Measure	Time frame
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum total cholesterol and low density lipoprotein (LDL) cholesterol	24 weeks
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum corrected calcium-phosphorus product (CaxP)	24 weeks

Countries

Austria, France, Germany, Greece, Hungary, Italy, Portugal, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026