An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis

Secondary Objective:

Evaluate the safety on the basis of adverse events, changes in laboratory values and vital signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: Sevelamer

Criteria

Inclusion criteria :

Men or women 18 years of age or older suffering from CKD not on dialysis or on a stable haemodialysis regimen

• If currently on 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 laboratory measurement:

• iPTH ≤ 1000 pg/mL at screening (including results obtained within 60 days prior to screening)

• If not taking a phosphate binder, a serum phosphorus measurement >5.5 mg/dL (1.78 mmol/L) at Screening (Visit 1).

• If taking a phosphate binder at screening, a serum phosphorus measurement > 5.5 mg/dL (1.78 mmol/L) after the two-weeks washout period at Visit 1a (Day 0).

• Willing and able to take Sevelamer carbonate alone as a phosphate binder for the duration of the study

• Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study

• Willing and able to maintain screening doses of vitamin D, and/or cinacalcet for the duration of the study, except for safety reasons

• If female and childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or intrauterine devices

• For patients not on dialysis expecting not to initiate dialysis for the duration of this study

• Signed 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 dysphagia or swallowing disorder

• Predisposition or current bowel obstruction,

• Severe gastrointestinal (GI) motility disorders including severe constipation

• 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

• Planned renal transplant or parathyroidectomy within 3 months of Visit 1

• 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.