Sevelamer Hydrochloride in Peritoneal Dialysis Patients (SERENE)

The University of Hong Kong (HKU)

Status: Completed

Conditions: Endstage Renal Disease

Treatments: Drug: sevelamer hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00745589

A111-104

Details and patient eligibility

About

To test the hypothesis that second-line fixed low-dose sevelamer hydrochloride therapy is as effective as first-line high-dose sevelamer hydrochloride therapy in limiting the progression of cardiovascular calcification.

Full description

Cardiovascular disease accounts for nearly 50% of the mortality and is the most frequent cause of hospitalization in ESRD patients. Hyperphosphatemia is increasingly recognized to be an important predictor of mortality and cardiovascular death in ESRD patients and is largely attributed to the increased prevalence of vascular calcification.

Enrollment: 60 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ESRD patients receiving long-term peritoneal dialysis treatment with hyperphosphatemia currently receiving aluminum-based phosphorus binders or whose phosphorus control remains suboptimal with calcium-based binders only
• Patients who cannot afford to self-pay sevelamer hydrochloride.
• Patients who provided informed consent for the study

Exclusion criteria

• Patients with underlying active malignancy
• Patients with cyanotic congenital heart disease
• Patients with poor general condition
• Patients with plan for living related kidney transplant within coming 1 year
• Female patients with pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

higher dose sevelamer

Active Comparator group

Description:

first-line higher dose sevelamer hydrochloride

Treatment:

Drug: sevelamer hydrochloride

low dose sevelamer

Active Comparator group

Description:

second-line fixed low-dose sevelamer hydrochloride added to calcium carbonate

Treatment:

Drug: sevelamer hydrochloride