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)

Phase 1

Conditions: Peritoneal dialysis
MedDRA version: 7.0Level: LLTClassification code 10034660

Registration Number: EUCTR2004-002174-32-GB

Lead Sponsor: Genzyme Europe BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

1. Willing and able to sign an informed consent form.
2. Men or women aged 18 years of age or older.
3. Decrease the requirement for patients to have been stable on PD to 8 weeks.
4. In the opinion of the investigator, expected to receive peritoneal dialysis for the duration of the study.
5. Reduce the baseline inclusion criteria for serum phosphorus to > 1.76 mmol/L (5.50 mg/dL).
6. Increase the inclusion criteria for the upper limit of serum calcium (adjusted for albumin) levels as measured at the baseline visit to 2.60 mmol/L (10.40 mg/dL).
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. Remove the criteria for inclusion of iPTH altogether.

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

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.

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

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