An open label, randomized, parallel design study to investigate the efficacy and safety of sevelamer hydrochloride (Renagel®) compared with calcium acetate in peritoneal dialysis patients (REN00304)Estudio abierto, aleatorizado, con grupos paralelos, para investigar la eficacia y la seguridad del clorhidrato de sevelamer (Renagel) en comparación al acetato de calcio en pacientes sometidos a diálisis peritoneal.
- Conditions
- Peritoneal dialysisMedDRA version: 7.0Level: LLTClassification code 10034660
- Registration Number
- EUCTR2004-002174-32-ES
- Lead Sponsor
- Genzyme Europe BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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 < 600 pg/mL(66 pmol/L) taken within the last 3 months prior to screening.
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus.<br>- Investigate the safety and tolerability of sevelamer <br>;Secondary Objective: Compare the effects of sevelamer TID and calcium acetate TID on:<br>- serum calcium- phosphorus (CaxPO4) product <br>- serum lipids (total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides)<br>- a number of plasma biomarkers: random blood glucose, glycoylated haemoglobin(HbA1C), bone specific alkaline phospahatase (BSAP), uric acid and c-reactive protein (CRP)<br>;Primary end point(s): Change in serum phosphorus levels from end of washout to Week 12.
- Secondary Outcome Measures
Name Time Method