Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis

NCT00268957 | Completed Phase 3

• 1 other identifier: GD3-199-301
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 29

Brief Summary

Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.

Conditions

Kidney Diseases; Chronic Renal Insufficiency; End-Stage Renal Disease

Keywords

Chronic; Hemodialysis; Kidney; Hyperphosphatemia; Chronic kidney disease; Chronic Renal Insufficiency

Outcome Measures

Primary Outcomes (2)

• Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed TID with meals on the control of serum phosphorus

  Up to 24 weeks

• Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals

  Up to 24 weeks

Secondary Outcomes (1)

• Compare sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets TID with meals on serum calcium-phosphorus product and serum lipid profile

  Up to 24 weeks

Study Arms (2)

1

EXPERIMENTAL

sevelamer carbonate powder

Drug: Sevelamer carbonate (Renvela®)

2

ACTIVE COMPARATOR

Sevelamer hydrochloride

Drug: Sevelamer hydrochloride (Renagel®)

Interventions

Sevelamer carbonate (Renvela®) DRUG

sevelamer carbonate powder dosed once per day with largest meal

1

Sevelamer hydrochloride (Renagel®) DRUG

Sevelamer hydrochloride tablets dosed three times a day with meals

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• On three times per week hemodialysis for three months or longer
• Currently on a phosphate binder(s)
• Considered compliant with phosphate binders and hemodialysis therapy
• Willing to avoid any intentional changes in diet such as fasting or dieting
• Have the following documented local laboratory measurements:a.Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 6.5 (6.5) mg/dL within 60 days of screening; b.A most recent intact parathyroid hormone (iPTH) measurement ≤ 800 pg/mL within 90 days of screening
• Have the following central laboratory measurements: a.A serum phosphorus measurement \> 5.5 mg/dL at randomization (Week 0);b.A serum iPTH measurement ≤ 800 pg/mL at screening
• Have not participated in any other investigational drug studies within 30 days prior to enrollment
• Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
• Willing and able to take sevelamer alone as a phosphate binder for the duration of the study
• Willing and able to maintain screening doses of lipid medication for the duration of the study, except for safety reasons
• Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement
• If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout the study, which includes barrier methods, hormones, or intrauterine devices (IUDs)
• Life expectancy of 12 months or greater
• Willing and able to provide informed consent

You may not qualify if:

• Active bowel obstruction, dysphagia, swallowing disorder, or severe gastrointestinal (GI) motility disorders
• Active ethanol or drug abuse, excluding tobacco use
• In the opinion of the Investigator, subject has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
• Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia or seizure disorders
• Known hypersensitivity to sevelamer or any constituents of the study drug
• Pregnant or breast-feeding
• Evidence of active malignancy except for basal cell carcinoma of the skin
• Unable to comply with the requirements of the study

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (29)

Clinical Research Center

Birmingham, Alabama, 35213, United States

Location

Gadsden Dialysis

Gadsden, Alabama, 35901, United States

Location

Holy Cross Renal Care

Mission Hills, California, 91345, United States

Location

Nephrology Educational Services and Research

Tarzana, California, 91356, United States

Location

Crystal Rivers Dialysis Center

Crystal River, Florida, 34429, United States

Location

Outcomes Research International, Inc.

Hudson, Florida, 34667, United States

Location

Central Dialysis Center

Atlanta, Georgia, 30329, United States

Location

Atlanta Nephrology Referral Center

Decatur, Georgia, 30030, United States

Location

FMC Marietta

Marietta, Georgia, 30066, United States

Location

Horizon Healthcare Associates

Flossmoor, Illinois, 60422, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Ochsner Clinic Foundation, Nephrology Research

New Orleans, Louisiana, 70121, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Southwest Mississippi Nephrology, PLLC

Brookhaven, Mississippi, 39601, United States

Location

Nephrology Associates, P.C.

Columbus, Mississippi, 39705, United States

Location

Nephrology & Hypertension Associates, LTD

Tupelo, Mississippi, 38801, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hypertension and Nephrology Associates

Eatontown, New Jersey, 07724, United States

Location

Winthrop University Dialysis Center

Mineola, New York, 11501, United States

Location

Davita

The Bronx, New York, 10461, United States

Location

Kidney and Hypertension Center

Cincinnati, Ohio, 45220, United States

Location

Renal Care Group

Cleveland, Ohio, 44109, United States

Location

Lewiston Dialysis Center

Lewistown, Pennsylvania, 17044, United States

Location

Medical Nephrology Associates

Dyersburg, Tennessee, 38024, United States

Location

Nephrology Associates, P.C.

Nashville, Tennessee, 37205, United States

Location

Renal Research Inc. at the Kidney Institute

Houston, Texas, 77054, United States

Location

Gambro Healthcare - Charlottesville

Charlottesville, Virginia, 22902, United States

Location

Clinical Research of Tidewater

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University, Division of Nephrology

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Bronchiolitis Obliterans Syndrome; Hyperphosphatemia

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 23, 2005
• Study Start: January 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: May 1, 2007
• Last Updated: March 19, 2014

Record last verified: 2014-03

Locations

US (29)