Clinical trial NCT00681941: An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Hyperphosphatemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels
timeFrame: Up to day 70
measure: Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals.
timeFrame: Up to day 70
Secondary outcomes:
measure: Serum calcium-phosphorus product
timeFrame: Up to day 70
measure: Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol]
timeFrame: Up to day 70
measure: Percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.87 and 1.49 mmol/L) inclusive] at Day 56/ET
timeFrame: Up to day 70
Other outcomes:
Locations:
city: Wooloongabba
country: Australia
facility: Nephrology Department, Princess Alexandra Hospital
state: Queensland
city: Woodville
country: Australia
facility: Renal Unit, The Queen Elizabeth Hospital
state: South Australia
city: Launceston
country: Australia
facility: Renal Research Unit, Launceston General Hospital
state: Tasmania
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital, Department of Nephrology
state: Victoria
city: Richmond
country: Australia
facility: Melbourne Renal Research Group, Epworth Medical Centre
state: Victoria
city: Aalborg
country: Denmark
facility: Nyremedicinsk Afdeling, Medicinerhuset
city: Hilleroed
country: Denmark
facility: Nefrologisk Afdeling, Hilleroed Sygehus
city: København
country: Denmark
facility: Medicinsk Afdeling
city: Roskilde
country: Denmark
facility: Medicinsk Afdeling, nefrologisk, Roskilde Sygehus
city: Paris
country: France
facility: George Pompidou, European Hospital
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, Medizinsche Klinik II
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Heidelberg
country: Germany
facility: Heimdialysezentrum
city: Nürnberg
country: Germany
facility: KfH Nierenzentrum
city: Solingen
country: Germany
facility: Stadt Klinken Solingen, Klinik für Nephrologie und Allgemeine Innere Medizin
city: Villingen-Schwenningen
country: Germany
facility: Nephrologisches Zentrum
city: Birmingham
country: United Kingdom
facility: Birmingham Hospital, Queen Elizabeth Medical Centre
state: England
city: Bristol
country: United Kingdom
facility: Southmead Hospital
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Dialysis Centre
state: England
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
state: England
city: London
country: United Kingdom
facility: Renal Department, The Royal London Hospital
state: England
city: London
country: United Kingdom
facility: Renal & Urology SDU Offices
state: England
city: Manchester
country: United Kingdom
facility: Renal Dialysis Unit, Manchester Royal Infirmary
state: England
city: Manchester
country: United Kingdom
facility: Department of Renal Medicine, Hope Hospital
state: England
city: Portsmouth
country: United Kingdom
facility: Renal Unit, Queen Alexandra Hospital
state: England
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: