An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis

NCT00681941 | Completed Phase 3

• 2 other identifiers: SVCARB00105ACTRN012606000380594
• Study Type: interventional
• Target: 49
• Locations: 5 countries
• Sites: 25

Brief Summary

Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.

Conditions

Chronic Kidney Disease; Hyperphosphatemia

Outcome Measures

Primary Outcomes (2)

• Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels

  Up to day 70

• Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals.

  Up to day 70

Secondary Outcomes (3)

• Serum calcium-phosphorus product

  Up to day 70

• Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol]

  Up to day 70

• Percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.87 and 1.49 mmol/L) inclusive] at Day 56/ET

  Up to day 70

Study Arms (1)

1

EXPERIMENTAL

Sevelamer Carbonate Tablets Dosed Three Times A Day

Drug: Sevelamer carbonate (Renvela®)

Interventions

Sevelamer carbonate (Renvela®) DRUG

Sevelamer Carbonate Tablets Dosed Three Times A Day

1

Eligibility Criteria

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

You may qualify if:

• A minimum of 120 male and female patients with chronic kidney disease not requiring dialysis will be screened for participation in the study.
• Men or woman 18 years of age or older
• If currently taking phosphate binder(s), willing to stop this and enter a 2 week washout period
• Willing to avoid any intentional changes in diet such as fasting or dieting
• Have the following central laboratory measurements: 1. If not on a phosphate binder, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) at Screening (Visit1). 2. If taking a phosphate binder(s) at screening, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) after the two-week washout period at Visit 1a (Day 0).
• At Screening (Visit 1), have the following central laboratory measurements: 1. 25-hydroxyvitamin D ≥ 10 ng/mL 2. iPTH ≤ 800 pg/mL
• Willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study
• Willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin D, and/or cinacalcet 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 study, which includes barrier methods, hormones, or IUDs
• Expecting not to initiate dialysis for the duration of this study
• Considered compliant with phosphate binders (if applicable)
• Willing and able to provide informed consent
• Has 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

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
• Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
• In the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
• 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
• Known hypersensitivity to sevelamer or any constituents of the study drug

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (25)

Nephrology Department, Princess Alexandra Hospital

Wooloongabba, Queensland, 4102, Australia

Location

Renal Unit, The Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

Renal Research Unit, Launceston General Hospital

Launceston, Tasmania, 7250, Australia

Location

The Royal Melbourne Hospital, Department of Nephrology

Parkville, Victoria, 3050, Australia

Location

Melbourne Renal Research Group, Epworth Medical Centre

Richmond, Victoria, 3121, Australia

Location

Nyremedicinsk Afdeling, Medicinerhuset

Aalborg, DK-9100, Denmark

Location

Medicinsk Afdeling

Copenhagen, DK-2100, Denmark

Location

Nefrologisk Afdeling, Hilleroed Sygehus

Hilleroed, DK 3400, Denmark

Location

Medicinsk Afdeling, nefrologisk, Roskilde Sygehus

Roskilde, DK-4000, Denmark

Location

George Pompidou, European Hospital

Paris, 75908, France

Location

Universitätsklinikum Aachen, Medizinsche Klinik II

Aachen, D-52074, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, D-20246, Germany

Location

Heimdialysezentrum

Heidelberg, D-69115, Germany

Location

KfH Nierenzentrum

Nuremberg, D-90431, Germany

Location

Stadt Klinken Solingen, Klinik für Nephrologie und Allgemeine Innere Medizin

Solingen, D 42653, Germany

Location

Nephrologisches Zentrum

Villingen-Schwenningen, D 78054, Germany

Location

Birmingham Hospital, Queen Elizabeth Medical Centre

Birmingham, England, B15 2PR, United Kingdom

Location

Southmead Hospital

Bristol, England, BS10 5NB, United Kingdom

Location

Addenbrooke's Dialysis Centre

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leicester General Hospital

Leicester, England, LE5 4PW, United Kingdom

Location

Renal Department, The Royal London Hospital

London, England, E1 1BB, United Kingdom

Location

Renal & Urology SDU Offices

London, England, SE1 9RT, United Kingdom

Location

Renal Dialysis Unit, Manchester Royal Infirmary

Manchester, England, M13 9WL, United Kingdom

Location

Department of Renal Medicine, Hope Hospital

Manchester, England, M6 8HD, United Kingdom

Location

Renal Unit, Queen Alexandra Hospital

Portsmouth, England, PO6 3RY, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 21, 2008
• Study Start: January 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: March 1, 2007
• Last Updated: March 20, 2015

Record last verified: 2015-03

Locations

FR (1); DK (4); DE (6); AU (5); GB (9)