NCT00745589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

6.3 years

First QC Date

September 1, 2008

Last Update Submit

June 17, 2020

Conditions

Endstage Renal Disease

Keywords

vascular,valvular calcification,phosphate binder,sevelamer,endstage renal diseaseperitoneal dialysis

Outcome Measures

Primary Outcomes (1)

  • Changes in coronary artery, aortic valve, mitral annulus calcium scores

    Vascular and valvular calcium scores

    over 24 months

Secondary Outcomes (11)

  • Changes in aortic pulse wave velocity

    over 24 months

  • annualized percentage change in Coronary artery calcium score

    over 12 months

  • Changess in serum T50

    over 24 months

  • Changes in serum calcium, phosphate

    over 24 months

  • Changes in alkaline phosphatase

    over 24 months

  • +6 more secondary outcomes

Study Arms (2)

higher dose sevelamer

ACTIVE COMPARATOR

first-line higher dose sevelamer hydrochloride

Drug: sevelamer hydrochloride

low dose sevelamer

ACTIVE COMPARATOR

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

Drug: sevelamer hydrochloride

Interventions

sevelamer hydrochlorideDRUG

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)

Also known as: Renagel
higher dose sevelamerlow dose sevelamer

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital, Tung Wah Hospital

Hong Kong, 0000, Hong Kong

Location

Related Publications (2)

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PMID: 40576086DERIVED

  • 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.

    PMID: 35243302DERIVED

MeSH Terms

Interventions

Sevelamer

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Study Officials

  • Angela YM Wang, MD, PhD

    Queen Mary Hospital, University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 1, 2008

First Posted

September 3, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2014

Study Completion

January 1, 2015

Last Updated

June 18, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)