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Sevelamer Hydrochloride in Peritoneal Dialysis Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00745589
First received: September 1, 2008
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Endstage Renal Disease
Drug: sevelamer hydrochloride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Sevelamer Hydrochloride to Control Hyperphosphatemia and Reduce Calcification Burden in the Poor Peritoneal Dialysis Patients

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Change in coronary artery and cardiac valvular calcification [ Time Frame: 12 months, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in aortic pulse wave velocity, bone mineral density of distal radius, femur and lumbar spine. Incidence of cardiovascular and non-cardiovascular related hospitalizations [ Time Frame: 12 months, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
first-line high dose sevelamer hydrochloride
Drug: sevelamer hydrochloride
First-line high 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 Name: Renagel
Active Comparator: 2
second-line fixed low-dose sevelamer hydrochloride
Drug: sevelamer hydrochloride
First-line high 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 Name: Renagel

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

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745589

Locations
Hong Kong
Queen Mary Hospital, Tung Wah Hospital
Hong Kong, Hong Kong, 0000
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Angela YM Wang, MD, PhD Queen Mary Hospital, University of Hong Kong
  More Information

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00745589     History of Changes
Other Study ID Numbers: A111-104
Study First Received: September 1, 2008
Last Updated: June 19, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
vascular,
valvular calcification,
phosphate binder,
sevelamer,
endstage renal disease
peritoneal dialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents

ClinicalTrials.gov processed this record on November 27, 2014