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)

Genzyme Europe BV0 个研究点目标入组 150 人开始时间: 2004年11月29日最近更新: 2012年3月19日

试验速览

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•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.

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