Peritoneal dialysis MedDRA version: 7.0 Level: LLT Classification code 10034660
Conditions
Interventions
Trade Name: Renagel 800mg
Product Name: Renagel
Pharmaceutical Form: Tablet
INN or Proposed INN: sevelamer
CAS Number: 182683-00-7
Other descriptive name: sevelamer hydrochloride
Concentration unit: m
Sponsors
Genzyme Europe BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to sign an informed consent form. 2. Men or women aged 18 years of age or older. 3. A diagnosis of CKD and receiving peritoneal dialysis (CAPD, APD or CCPD) for 3 months or longer. 4. In the opinion of the investigator, expected to receive peritoneal dialysis for the duration of the study. 5. Will have a serum phosphorus level >1.93 mmol/L(6.0 mg/dL) after 2 weeks washout from their usual phosphate binder. 6. Will have serum calcium measurement adjusted for albumin within the normal range (2.10-2.54 mmol/L (8.4-10.2 mg/dL) following 2 weeks washout from their usual phosphate binder. 7. Willing to maintain the prescribed sevelamer or calcium acetate for the duration of the study. 8. Considered compliant with phosphate binders and dialysis. 9. Most recent intact parathyroid hormone (iPTH) measurement =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with a history of peritonitis in the last 30 days or > 2 episodes in the last 12 months 2. Patient with active dysphagia, swallowing disorder, bowel obstruction, or severe gastrointestinal motility disorder. 3. Patients who in the opinion of the investigator have poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant, unstable medical condition. 4. Patients with any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus. - Investigate the safety and tolerability of sevelamer ;Secondary Objective: Compare the effects of sevelamer TID and calcium acetate TID on: - serum calcium- phosphorus (CaxPO4) product - serum lipids (total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides) - a number of plasma biomarkers: random blood glucose, glycoylated haemoglobin(HbA1C), bone specific alkaline phospahatase (BSAP), uric acid and c-reactive protein (CRP) ;Primary end point(s): Change in serum phosphorus levels from end of washout to Week 12. | — |
Countries
Denmark, Italy, Spain, United Kingdom
Outcome results
None listed