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

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00681941
First received: May 19, 2008
Last updated: August 3, 2009
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Hyperphosphatemia
Drug: Sevelamer carbonate (Renvela®)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Dose Titration of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels [ Time Frame: Up to day 70 ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals. [ Time Frame: Up to day 70 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum calcium-phosphorus product [ Time Frame: Up to day 70 ] [ Designated as safety issue: No ]
  • Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol] [ Time Frame: Up to day 70 ] [ Designated as safety issue: No ]
  • Percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.87 and 1.49 mmol/L) inclusive] at Day 56/ET [ Time Frame: Up to day 70 ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: January 2006
Study Completion Date: March 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sevelamer Carbonate Tablets Dosed Three Times A Day
Drug: Sevelamer carbonate (Renvela®)
Sevelamer Carbonate Tablets Dosed Three Times A Day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681941

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

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00681941     History of Changes
Other Study ID Numbers: SVCARB00105, ACTRN012606000380594
Study First Received: May 19, 2008
Last Updated: August 3, 2009
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Kidney Diseases
Hyperphosphatemia
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014