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

Overview

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)

Full Title of Study: “An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic Chronic Kidney Disease Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2014

Detailed Description

10 weeks including, 2 weeks wash-out period and 8 weeks study treatment period

Interventions

  • Drug: sevelamer carbonate 800mg
    • Pharmaceutical form:tablet Route of administration: oral
  • Drug: sevelamer carbonate 2.4 g
    • Pharmaceutical form:powder Route of administration: oral

Arms, Groups and Cohorts

  • Experimental: CKD patients not on dialysis 800 mg
    • Sevelamer carbonate 800 mg in tabs 3 times per day with meals
  • Experimental: CKD patients not on dialysis 2.4 g
    • Sevelamer carbonate 2.4 g powder carbonate per day
  • Experimental: CKD patients on dialysis 800 mg
    • Sevelamer carbonate 800 mg in tabs 3 times per day with meals
  • Experimental: CKD patients on dialysis 2.4 g
    • Sevelamer carbonate 2.4 g powder carbonate per day

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: up to 8 weeks

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Genzyme, a Sanofi Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Sciences & Operations, Study Director, Sanofi

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