Clinical trial NCT00745589: Sevelamer Hydrochloride in Peritoneal Dialysis Patients
Official title: Use of Sevelamer Hydrochloride to Control Hyperphosphatemia and Reduce Calcification Burden in the Poor Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endstage Renal Disease
Keywords: vascular,
valvular calcification,
phosphate binder,
sevelamer,
endstage renal disease
peritoneal dialysis
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in coronary artery, aortic valve, mitral annulus calcium scores
timeFrame: over 24 months
Secondary outcomes:
measure: Changes in aortic pulse wave velocity
timeFrame: over 24 months
measure: annualized percentage change in Coronary artery calcium score
timeFrame: over 12 months
measure: Changess in serum T50
timeFrame: over 24 months
measure: Changes in serum calcium, phosphate
timeFrame: over 24 months
measure: Changes in alkaline phosphatase
timeFrame: over 24 months
measure: Changes in intact parathyroid hormone
timeFrame: over 24 months
measure: Changes in low density lipoprotein-cholesterol
timeFrame: over 24 months
measure: Changes in C-reactive protein
timeFrame: over 24 months
measure: Changes in systolic blood pressure
timeFrame: over 24 months
measure: Changes in diastolic blood pressure
timeFrame: over 24 months
measure: Changes in Forearm, femur and spine bone mineral density, T score and Z score
timeFrame: over 24 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, Tung Wah Hospital
Study officials:
affiliation: Queen Mary Hospital, University of Hong Kong
name: Angela YM Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.