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

March 19, 2015 updated by: Genzyme, a Sanofi Company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Universitatsklinikum 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Up to day 70
Up to day 70
Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals.
Time Frame: Up to day 70
Up to day 70

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Serum calcium-phosphorus product
Time Frame: Up to day 70
Up to day 70
Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol]
Time Frame: Up to day 70
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
Time Frame: Up to day 70
Up to day 70

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2006

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2007

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SVCARB00105
  • ACTRN012606000380594

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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