Sevelamer Hydrochloride in Peritoneal Dialysis Patients (SERENE)

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

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.

Study Overview

• Status: Completed
• Conditions: Endstage Renal Disease
• Intervention / Treatment: Drug: sevelamer hydrochloride

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 0000
    • Queen Mary Hospital, Tung Wah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: higher dose sevelamer; first-line higher dose sevelamer hydrochloride	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); Other Names: Renagel
Active Comparator: low dose sevelamer; second-line fixed low-dose sevelamer hydrochloride added to calcium carbonate	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); Other Names: Renagel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in coronary artery, aortic valve, mitral annulus calcium scores	Vascular and valvular calcium scores	over 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Angela YM Wang, MD, PhD, Queen Mary Hospital, University of Hong Kong

Publications and helpful links

General Publications

• Wang AY, Pasch A, Wong CK, Chu IM, Tang TK, Chu J, Cheuk-Ying Fong C, Yau YY, Lo WK. Long-Term Effects of Sevelamer on Vascular Calcification, Arterial Stiffness, and Calcification Propensity in Patients Receiving Peritoneal Dialysis: The Randomized Pilot SERENE (Sevelamer on Vascular Calcification, Arterial Stiffness) Trial. Kidney Med. 2021 Nov 2;4(2):100384. doi: 10.1016/j.xkme.2021.10.002. eCollection 2022 Feb.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: September 1, 2008
• First Submitted That Met QC Criteria: September 2, 2008
• First Posted (Estimate): September 3, 2008

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: peritoneal dialysis; vascular,; valvular calcification,; phosphate binder,; sevelamer,; endstage renal disease
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Sevelamer
• Other Study ID Numbers: A111-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO