Endstage Renal DiseaseSERENENCT00745589
Sevelamer Hydrochloride in Peritoneal Dialysis Patients
A study testing sevelamer hydrochloride in people with Endstage Renal Disease, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Endstage Renal Disease
- What is being tested?
- sevelamer hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2008to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Endstage Renal Disease
- Being tested
- sevelamer hydrochloride
- Keywords
- vascular,, valvular calcification,, phosphate binder,, sevelamer,, endstage renal disease, peritoneal dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevelamer hydrochlorideDrug
Also called Renagel
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)
| Study group | Role | What they receive |
|---|---|---|
| higher dose sevelamer | Active comparator | first-line higher dose sevelamer hydrochloride Receives: Drug: sevelamer hydrochloride |
| low dose sevelamer | Active comparator | second-line fixed low-dose sevelamer hydrochloride added to calcium carbonate Receives: Drug: sevelamer hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in coronary artery, aortic valve, mitral annulus calcium scores
Vascular and valvular calcium scores
Measured: over 24 months
Secondary outcomes (11)
Changes in aortic pulse wave velocity
arterial stiffness parameter
Measured: over 24 months
annualized percentage change in Coronary artery calcium score
annualized percentage change in calcium score
Measured: over 12 months
Changess in serum T50
serum calcification propensity measure
Measured: over 24 months
Changes in serum calcium, phosphate
biochemical parameters
Measured: over 24 months
Changes in alkaline phosphatase
biochemical parameters
Measured: over 24 months
Changes in intact parathyroid hormone
biochemical parameters
Measured: over 24 months
Changes in low density lipoprotein-cholesterol
biochemical parameters
Measured: over 24 months
Changes in C-reactive protein
biochemical parameters
Measured: over 24 months
Changes in systolic blood pressure
blood pressure
Measured: over 24 months
Changes in diastolic blood pressure
blood pressure
Measured: over 24 months
Changes in Forearm, femur and spine bone mineral density, T score and Z score
Bone mineral density related parameters
Measured: over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endstage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Angela Yee-Moon Wang, The University of Hong Kong
- Investigators
- Angela YM Wang, MD, PhD, Principal investigator, Queen Mary Hospital, University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745589
- Sponsor's protocol ID
- A111-104
- Acronym
- SERENE
- Status last verified
- Jun 2020
- First submitted
- 1 Sep 2008
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40576086Wang 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.
PubMed 35243302
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Sevelamer Hydrochloride to Control Hyperphosphatemia and Reduce Calcification Burden in the Poor Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT00745589
- Acronym / sponsor ID
- SERENE / A111-104
- Conditions
- Endstage Renal Disease
- Keywords
- vascular,, valvular calcification,, phosphate binder,, sevelamer,, endstage renal disease, peritoneal dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| higher dose sevelamer | Active comparator | Drug: sevelamer hydrochloridefirst-line higher dose sevelamer hydrochloride |
| low dose sevelamer | Active comparator | Drug: sevelamer hydrochloridesecond-line fixed low-dose sevelamer hydrochloride added to calcium carbonate |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sevelamer hydrochlorideAlso: RenagelFirst-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) | Drug | higher dose sevelamer, low dose sevelamer |
Primary outcome
Changes in coronary artery, aortic valve, mitral annulus calcium scores
Time frame: over 24 months
Vascular and valvular calcium scores
11 secondary outcomes
Changes in aortic pulse wave velocity
Time frame: over 24 months
annualized percentage change in Coronary artery calcium score
Time frame: over 12 months
Changess in serum T50
Time frame: over 24 months
Changes in serum calcium, phosphate
Time frame: over 24 months
Changes in alkaline phosphatase
Time frame: over 24 months
Changes in intact parathyroid hormone
Time frame: over 24 months
Changes in low density lipoprotein-cholesterol
Time frame: over 24 months
Changes in C-reactive protein
Time frame: over 24 months
Changes in systolic blood pressure
Time frame: over 24 months
Changes in diastolic blood pressure
Time frame: over 24 months
Changes in Forearm, femur and spine bone mineral density, T score and Z score
Time frame: over 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Derived from this study: PubMed 40576086Natale 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.
- Derived from this study: PubMed 35243302Wang 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.
- Individual participant dataSharing planned: No
Related trials for Endstage Renal Disease
Recruiting
Effect of Apiban Therapy on AVF Maturation in ESRD Patients
Endstage Renal Disease, Direct Oral Anticoagulants (DOACs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela YM Wang, MD, PhD principal investigator
Queen Mary Hospital, University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sevelamer hydrochloride in people with Endstage Renal Disease, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in coronary artery, aortic valve, mitral annulus calcium scores (time frame: over 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00745589, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.