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

An Open Label, Dose Titration of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Hyperphosphatemia
• Intervention / Treatment: Drug: Sevelamer carbonate (Renvela®)

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Wooloongabba, Queensland, Australia, 4102
      • Nephrology Department, Princess Alexandra Hospital
  • South Australia
    • Woodville, South Australia, Australia, 5011
      • Renal Unit, The Queen Elizabeth Hospital
  • Tasmania
    • Launceston, Tasmania, Australia, 7250
      • Renal Research Unit, Launceston General Hospital
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital, Department of Nephrology
    • Richmond, Victoria, Australia, 3121
      • Melbourne Renal Research Group, Epworth Medical Centre
• Denmark
  • Aalborg, Denmark, DK-9100
    • Nyremedicinsk Afdeling, Medicinerhuset
  • Hilleroed, Denmark, DK 3400
    • Nefrologisk Afdeling, Hilleroed Sygehus
  • København, Denmark, DK-2100
    • Medicinsk Afdeling
  • Roskilde, Denmark, DK-4000
    • Medicinsk Afdeling, nefrologisk, Roskilde Sygehus
• France
  • Paris, France, 75908
    • George Pompidou, European Hospital
• Germany
  • Aachen, Germany, D-52074
    • Universitätsklinikum Aachen, Medizinsche Klinik II
  • Hamburg, Germany, D-20246
    • Universitätsklinikum Hamburg Eppendorf
  • Heidelberg, Germany, D-69115
    • Heimdialysezentrum
  • Nürnberg, Germany, D-90431
    • KfH Nierenzentrum
  • Solingen, Germany, D 42653
    • Stadt Klinken Solingen, Klinik für Nephrologie und Allgemeine Innere Medizin
  • Villingen-Schwenningen, Germany, D 78054
    • Nephrologisches Zentrum
• United Kingdom
  • England
    • Birmingham, England, United Kingdom, B15 2PR
      • Birmingham Hospital, Queen Elizabeth Medical Centre
    • Bristol, England, United Kingdom, BS10 5NB
      • Southmead Hospital
    • Cambridge, England, United Kingdom, CB2 2QQ
      • Addenbrooke's Dialysis Centre
    • Leicester, England, United Kingdom, LE5 4PW
      • Leicester General Hospital
    • London, England, United Kingdom, E1 1BB
      • Renal Department, The Royal London Hospital
    • London, England, United Kingdom, SE1 9RT
      • Renal & Urology SDU Offices
    • Manchester, England, United Kingdom, M13 9WL
      • Renal Dialysis Unit, Manchester Royal Infirmary
    • Manchester, England, United Kingdom, M6 8HD
      • Department of Renal Medicine, Hope Hospital
    • Portsmouth, England, United Kingdom, PO6 3RY
      • Renal Unit, Queen Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Any other condition, which in the opinion of the investigator will prohibit the patient's inclusion in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Sevelamer Carbonate Tablets Dosed Three Times A Day	Drug: Sevelamer carbonate (Renvela®); Sevelamer Carbonate Tablets Dosed Three Times A Day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (ACTUAL): January 1, 2007
• Study Completion (ACTUAL): March 1, 2007

Study Registration Dates

• First Submitted: May 19, 2008
• First Submitted That Met QC Criteria: May 20, 2008
• First Posted (ESTIMATE): May 21, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 20, 2015
• Last Update Submitted That Met QC Criteria: March 19, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Renal Insufficiency; Phosphorus Metabolism Disorders; Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Sevelamer
• Other Study ID Numbers: SVCARB00105; ACTRN012606000380594