NCT00324376

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. 1.sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

First QC Date

May 9, 2006

Last Update Submit

March 4, 2015

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

Sevelamer hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Renal Care Group

Olympia Fields, Illinois, United States

Location

Kidney and Hypertension Center

Cincinnati, Ohio, United States

Location

Related Publications (2)

  • 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.

    PMID: 40576086DERIVED

  • Fishbane S, Delmez J, Suki WN, Hariachar SK, Heaton J, Chasan-Taber S, Plone MA, Moe S. A randomized, parallel, open-label study to compare once-daily sevelamer carbonate powder dosing with thrice-daily sevelamer hydrochloride tablet dosing in CKD patients on hemodialysis. Am J Kidney Dis. 2010 Feb;55(2):307-15. doi: 10.1053/j.ajkd.2009.10.051. Epub 2009 Dec 30.

    PMID: 20042256DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 11, 2006

Study Start

March 1, 2003

Study Completion

May 1, 2004

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

US(2)