A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not on Dialysis

Conditions: Treatment of hyperphosphataemia
MedDRA version: 9.1Level: LLTClassification code 10064848Term: Chronic kidney disease

Registration Number: EUCTR2007-003885-16-AT

Lead Sponsor: Genzyme Europe BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

Patients must meet the following criteria to be enrolled in the study:
1. Willing and able to provide written informed consent.
2. Men or women 18 years of age or older.
3. If currently on phosphate binder(s), willing to stop the phosphate binder and enter a 14-21 day Washout Period.
4. Have been, in the opinion of the Investigator, stable on a phosphate-controlled diet at Screening and be willing to avoid any intentional changes, such as fasting or dieting for the duration of the study.
5. Have the following central laboratory measurements:
• If not taking a phosphate binder at Screening, a serum phosphorous measurement =4.6 mg/dL (=1.49 mmol/L) and =5.5 mg/dL (=1.76 mmol/L) at Screening.
• If taking a phosphate binder at Screening, a serum phosphorous measurement =4.6 mg/dL (=1.49mmol/L) and =5.5 mg/dL (=1.76 mmol/L) after the 14-21 day Washout Period; at the Post-Washout Visit.
6. Willing and able to take the Investigational Product as a phosphate binder for the duration of the study.
7. Willing and able to maintain screening doses of lipid-lowering medication for the duration of the study, except for safety reasons.
8. Willing and able to maintain doses of medication for control of hyperparathyroidism from Screening through Week 12, except for safety reasons.
9. Willing and able to avoid antacids and phosphate binders containing aluminium, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement.
10. Willing, if female and of childbearing potential (pre-menopausal and not surgically sterile), to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or intrauterine device(s).
11. Expecting not to initiate dialysis or have a kidney transplant for the duration of this study.
12. Be considered compliant with phosphate binders (if applicable).
13. Has not participated in any other investigational drug studies within 30 days prior to enrolment.
14. Have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel.
15. Able to be contacted by phone or other remote means in order to be informed of Investigational Product dose changes.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from this study if they do not meet the specific inclusion criteria, or if they are/have:
1. Active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.
2. Previous major gastrointestinal tract surgery.
3. In the opinion of the Investigator, active ethanol or drug abuser, excluding tobacco use.
4. Use of anti-arrhythmics for arrhythmias or anti-seizure medications for seizures.
5. At Screening, the following central laboratory measurements:
• Serum 25-hydroxyvitamin D <10 ng/mL (<25 nmol/L),
• Serum intact parathyroid hormone (iPTH) =600 pg/mL (=66 pmol/L), and
• Serum LDL >140 mg/dL (>3.59 mmol/L).
6. In the opinion of the Investigator, any clinically significant unstable medical condition, for example:
poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection.
7. Pregnant or breast-feeding.
8. Evidence of active malignancy except for basal cell carcinoma of the skin.
9. Unable to comply with the requirements of the study.
10. A known hypersensitivity to the Investigational Product or any of its constituents.
11. Any other condition, which in the opinion of the Investigator, would mean participation in the study would not be in the patient’s best interest.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times a day (TID) on serum<br>phosphorous levels.<br>;Secondary Objective: To compare the effects of sevelamer carbonate dosed TID and placebo dosed TID on the following:<br>• Serum total cholesterol and low density lipoprotein (LDL) cholesterol<br>• Serum corrected calcium-phosphorous product (CaxP)<br>;Primary end point(s): The primary efficacy endpoint is serum phosphorous change from Baseline to Week 12/Titration Period Early Termination (TPET).<br>

Secondary Outcome Measures

Name	Time	Method

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