Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients

Hemodialysis Clinical Trial

Official title:

Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755078
• Other study ID #: CPT-REN-002
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2012
• Last updated: August 4, 2014
• Start date: June 2007
• Est. completion date: June 2009

Study information

• Verified date: December 2012
• Source: Chugai Pharma Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis patients to achieve full-scale of medical care, including reduction of atherosclerotic risk factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Males or females aged between 18-70 years old

• Subject with hyperphosphatemia (5.5 - 8.5 mg/dL) at both WK(-2) and WK0

• On stable TIW hemodialysis for 3 months or longer

Exclusion Criteria:

• Patients with hypercalcemia (corrected serum calcium > 10.5 mg/dL)

• Any of the following abnormalities: ALT or AST > 3X ULN; iPTH > 1000 or < 150 pg/mL

• History of dysphagia or swallowing disorders

• History of GI motility disorder or GI bleeding within 3 months prior to entry

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Events
• Hemodialysis
• Hyperphosphatemia

Intervention

Drug:
• Sevelamer HCl
Non-metal phosphate binder
• Calcium-based phosphate binder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharma Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite end-point of Ca, P, Ca*P within K/DOQI recommendation		12 months	No
Secondary	Change from baseline, Ca, P, Ca*P		12 months	No
Secondary	Change from baseline, lipid profile		12 months	No
Secondary	Change from baseline, CRP		12 months	No
Secondary	Change from baseline, iPTH (stragified)		12 months	No
Secondary	Change from baseline, homocysteine, folate and Vit B12		12 months	Yes
Secondary	CV-related event rate (OPD admission and hospitalization)		12 months	Yes
Secondary	Comparison of medical-related expenses between group		12 months	No