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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00681941




Registration number
NCT00681941
Ethics application status
Date submitted
19/05/2008
Date registered
21/05/2008
Date last updated
20/03/2015

Titles & IDs
Public title
An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis
Scientific title
An Open Label, Dose Titration of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis
Secondary ID [1] 0 0
ACTRN012606000380594
Secondary ID [2] 0 0
SVCARB00105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Hyperphosphatemia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sevelamer carbonate (Renvela®)

Experimental: 1 - Sevelamer Carbonate Tablets Dosed Three Times A Day


Treatment: Drugs: Sevelamer carbonate (Renvela®)
Sevelamer Carbonate Tablets Dosed Three Times A Day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels
Timepoint [1] 0 0
Up to day 70
Primary outcome [2] 0 0
Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals.
Timepoint [2] 0 0
Up to day 70
Secondary outcome [1] 0 0
Serum calcium-phosphorus product
Timepoint [1] 0 0
Up to day 70
Secondary outcome [2] 0 0
Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol]
Timepoint [2] 0 0
Up to day 70
Secondary outcome [3] 0 0
Percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.87 and 1.49 mmol/L) inclusive] at Day 56/ET
Timepoint [3] 0 0
Up to day 70

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Nephrology Department, Princess Alexandra Hospital - Wooloongabba
Recruitment hospital [2] 0 0
Renal Unit, The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 0 0
Renal Research Unit, Launceston General Hospital - Launceston
Recruitment hospital [4] 0 0
The Royal Melbourne Hospital, Department of Nephrology - Parkville
Recruitment hospital [5] 0 0
Melbourne Renal Research Group, Epworth Medical Centre - Richmond
Recruitment postcode(s) [1] 0 0
4102 - Wooloongabba
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
7250 - Launceston
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aalborg
Country [2] 0 0
Denmark
State/province [2] 0 0
Hilleroed
Country [3] 0 0
Denmark
State/province [3] 0 0
København
Country [4] 0 0
Denmark
State/province [4] 0 0
Roskilde
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
Germany
State/province [6] 0 0
Aachen
Country [7] 0 0
Germany
State/province [7] 0 0
Hamburg
Country [8] 0 0
Germany
State/province [8] 0 0
Heidelberg
Country [9] 0 0
Germany
State/province [9] 0 0
Nürnberg
Country [10] 0 0
Germany
State/province [10] 0 0
Solingen
Country [11] 0 0
Germany
State/province [11] 0 0
Villingen-Schwenningen
Country [12] 0 0
United Kingdom
State/province [12] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genzyme, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00681941
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Genzyme, a Sanofi Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00681941