Sevelamer Hydrochloride in Peritoneal Dialysis Patients

Endstage Renal Disease Clinical Trial

— SERENE  

Official title:

Use of Sevelamer Hydrochloride to Control Hyperphosphatemia and Reduce Calcification Burden in the Poor Peritoneal Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745589
• Other study ID #: A111-104
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: January 2015

Study information

• Verified date: June 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Endstage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• sevelamer hydrochloride
First-line higher dose (that is, 800mg TDS and up to a maximum of 1200mg TDS) sevelamer hydrochloride will be compared against low dose second-line sevelamer hydrochloride (that is, fixed dose of 400mg TDS)

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital, Tung Wah Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in coronary artery, aortic valve, mitral annulus calcium scores	Vascular and valvular calcium scores	over 24 months
Secondary	Changes in aortic pulse wave velocity	arterial stiffness parameter	over 24 months
Secondary	annualized percentage change in Coronary artery calcium score	annualized percentage change in calcium score	over 12 months
Secondary	Changess in serum T50	serum calcification propensity measure	over 24 months
Secondary	Changes in serum calcium, phosphate	biochemical parameters	over 24 months
Secondary	Changes in alkaline phosphatase	biochemical parameters	over 24 months
Secondary	Changes in intact parathyroid hormone	biochemical parameters	over 24 months
Secondary	Changes in low density lipoprotein-cholesterol	biochemical parameters	over 24 months
Secondary	Changes in C-reactive protein	biochemical parameters	over 24 months
Secondary	Changes in systolic blood pressure	blood pressure	over 24 months
Secondary	Changes in diastolic blood pressure	blood pressure	over 24 months
Secondary	Changes in Forearm, femur and spine bone mineral density, T score and Z score	Bone mineral density related parameters	over 24 months