Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing

A Randomized, Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00324376

Enrollment

Registered

2006-05-11

Start date

2003-03-31

Completion date

2004-05-31

Last updated

2015-03-05

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

Conditions

Chronic Kidney Disease

Brief summary

A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences: 1. sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals 2. sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening.

Interventions

DRUGSevelamer hydrochloride

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* life expectancy of at least 12 months, * patients have received hemodialysis three times per week for 3 months or longer, * patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL (0.97 and 2.10 mmol/L).

Exclusion criteria

* active bowel obstruction, * dysphagia, * swallowing disorders, * severe gastrointestinal motility disorders, * active ethanol or drug abuse (excluding tobacco), * need for antidysrhythmic or antiseizure medications used to control these conditions, * poorly controlled diabetes mellitus or hypertension, * active vasculitis, * active malignancy other than basal-cell carcinoma, * HIV infection, * any clinically significant unstable medical condition as judged by the investigator.

Design outcomes

Primary

Measure	Time frame
Treatment compared on basis of serum phosphorus at end of each treatment and calcium corrected for albumin,calcium-phosphorus product,albumin,iPTH,total,LDL,HDL,non-HDL cholesterol,triglycerides. Safety evaluated on AEs;change in lab values.	—

Countries

United States

Outcome results

None listed

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