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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681941
• Other study ID #: SVCARB00105
• Secondary ID: ACTRN01260600038
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2008
• Last updated: March 19, 2015
• Start date: January 2006
• Est. completion date: March 2007

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sevelamer carbonate (Renvela®)
Sevelamer Carbonate Tablets Dosed Three Times A Day

Locations

Country	Name	City	State
Australia	Renal Research Unit, Launceston General Hospital	Launceston	Tasmania
Australia	The Royal Melbourne Hospital, Department of Nephrology	Parkville	Victoria
Australia	Melbourne Renal Research Group, Epworth Medical Centre	Richmond	Victoria
Australia	Renal Unit, The Queen Elizabeth Hospital	Woodville	South Australia
Australia	Nephrology Department, Princess Alexandra Hospital	Wooloongabba	Queensland
Denmark	Nyremedicinsk Afdeling, Medicinerhuset	Aalborg
Denmark	Nefrologisk Afdeling, Hilleroed Sygehus	Hilleroed
Denmark	Medicinsk Afdeling	København
Denmark	Medicinsk Afdeling, nefrologisk, Roskilde Sygehus	Roskilde
France	George Pompidou, European Hospital	Paris
Germany	Universitätsklinikum Aachen, Medizinsche Klinik II	Aachen
Germany	Universitätsklinikum Hamburg Eppendorf	Hamburg
Germany	Heimdialysezentrum	Heidelberg
Germany	KfH Nierenzentrum	Nürnberg
Germany	Stadt Klinken Solingen, Klinik für Nephrologie und Allgemeine Innere Medizin	Solingen
Germany	Nephrologisches Zentrum	Villingen-Schwenningen
United Kingdom	Birmingham Hospital, Queen Elizabeth Medical Centre	Birmingham	England
United Kingdom	Southmead Hospital	Bristol	England
United Kingdom	Addenbrooke's Dialysis Centre	Cambridge	England
United Kingdom	Leicester General Hospital	Leicester	England
United Kingdom	Renal & Urology SDU Offices	London	England
United Kingdom	Renal Department, The Royal London Hospital	London	England
United Kingdom	Department of Renal Medicine, Hope Hospital	Manchester	England
United Kingdom	Renal Dialysis Unit, Manchester Royal Infirmary	Manchester	England
United Kingdom	Renal Unit, Queen Alexandra Hospital	Portsmouth	England

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Australia,  Denmark,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals.		Up to day 70	No
Secondary	Serum calcium-phosphorus product		Up to day 70	No
Secondary	Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol]		Up to day 70	No
Secondary	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	No