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Sevelamer Hydrochloride in Peritoneal Dialysis Patients (SERENE)

Primary Purpose

Endstage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
sevelamer hydrochloride
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endstage Renal Disease focused on measuring vascular,, valvular calcification,, phosphate binder,, sevelamer,, endstage renal disease, peritoneal dialysis

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Queen Mary Hospital, Tung Wah Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

higher dose sevelamer

low dose sevelamer

Arm Description

first-line higher dose sevelamer hydrochloride

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

Outcomes

Primary Outcome Measures

Changes in coronary artery, aortic valve, mitral annulus calcium scores
Vascular and valvular calcium scores

Secondary Outcome Measures

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

Full Information

First Posted
September 1, 2008
Last Updated
June 17, 2020
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00745589
Brief Title
Sevelamer Hydrochloride in Peritoneal Dialysis Patients
Acronym
SERENE
Official Title
Use of Sevelamer Hydrochloride to Control Hyperphosphatemia and Reduce Calcification Burden in the Poor Peritoneal Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endstage Renal Disease
Keywords
vascular,, valvular calcification,, phosphate binder,, sevelamer,, endstage renal disease, peritoneal dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
higher dose sevelamer
Arm Type
Active Comparator
Arm Description
first-line higher dose sevelamer hydrochloride
Arm Title
low dose sevelamer
Arm Type
Active Comparator
Arm Description
second-line fixed low-dose sevelamer hydrochloride added to calcium carbonate
Intervention Type
Drug
Intervention Name(s)
sevelamer hydrochloride
Other Intervention Name(s)
Renagel
Intervention Description
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)
Primary Outcome Measure Information:
Title
Changes in coronary artery, aortic valve, mitral annulus calcium scores
Description
Vascular and valvular calcium scores
Time Frame
over 24 months
Secondary Outcome Measure Information:
Title
Changes in aortic pulse wave velocity
Description
arterial stiffness parameter
Time Frame
over 24 months
Title
annualized percentage change in Coronary artery calcium score
Description
annualized percentage change in calcium score
Time Frame
over 12 months
Title
Changess in serum T50
Description
serum calcification propensity measure
Time Frame
over 24 months
Title
Changes in serum calcium, phosphate
Description
biochemical parameters
Time Frame
over 24 months
Title
Changes in alkaline phosphatase
Description
biochemical parameters
Time Frame
over 24 months
Title
Changes in intact parathyroid hormone
Description
biochemical parameters
Time Frame
over 24 months
Title
Changes in low density lipoprotein-cholesterol
Description
biochemical parameters
Time Frame
over 24 months
Title
Changes in C-reactive protein
Description
biochemical parameters
Time Frame
over 24 months
Title
Changes in systolic blood pressure
Description
blood pressure
Time Frame
over 24 months
Title
Changes in diastolic blood pressure
Description
blood pressure
Time Frame
over 24 months
Title
Changes in Forearm, femur and spine bone mineral density, T score and Z score
Description
Bone mineral density related parameters
Time Frame
over 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela YM Wang, MD, PhD
Organizational Affiliation
Queen Mary Hospital, University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital, Tung Wah Hospital
City
Hong Kong
ZIP/Postal Code
0000
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35243302
Citation
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.
Results Reference
derived

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Sevelamer Hydrochloride in Peritoneal Dialysis Patients

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