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Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genzyme
ClinicalTrials.gov Identifier:
NCT01736150
First received: November 26, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

The study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients on dialysis.


Condition Intervention Phase
Chronic Kidney Disease
Chronic Kidney Disease on Hemodialysis
 Drug: Placebo
Drug: Sevelamer carbonate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study of Sevelamer Carbonate in CKD Patients on Hemodialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Frequency of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, and changes in vital signs. [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 205
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sevelamer carbonate
Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site.
 Drug: Sevelamer carbonate
  • Starting dose 1 tablet (800 mg), three times per day (2.4 g/day) with meals.
  • If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet(800mg).Three times daily with meals.
Other Name: Renvela
Placebo Comparator: Placebo
Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site.
 Drug: Placebo
  • Starting dose of 1 tablet (800mg), three times per day (2.4g/day)with meals.
  • If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet (800 mg). Three times daily with meals.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On hemodialysis regimen scheduled for four hour duration three times per week for a minimum 30 days prior to Visit 1 and throughout the study
  • Have a central laboratory serum iPTH measurement less than 1000 pg/mL at Visit 1
  • Have a central laboratory serum phosphorus measurement greater than 5.5 mg/dL at Visit 1a

Exclusion Criteria:

  • Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal (GI) motility disorders including severe constipation
  • Documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any clinically significant unstable medical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736150

Locations
China
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
West China Hospital
Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, China
Southwest Hospital
Chongqing, China
Guangzhou First Municipal People's Hospital
Guangzhou, China
Nanfang Hospital
Guangzhou, China
Sun Yat-Sen University School of Medicine 1st Affiliated Hospital
Guangzhou, China
Zhejiang University School of Medicine 1st Affiliated Hospital
Hangzhou, China
Zhongda Hospital of Southeast University
Nanjing, China
Jiangsu Province Hospital
Nanjing, China
Qingdao Municipal Hospital
Qingdao, China
Renji Hospital
Shanghai, China
Changzheng Hospital
Shanghai, China
Zhongshan Hospital
Shanghai, China
Xinhua Hospital
Shanghai, China
Shanghai Ruijin Hospital
Shanghai, China
Wenzhou College of Medicine 1st Affiliated Hospital
Wenzhou, China
Sponsors and Collaborators
Genzyme
Investigators
Study Director: Medical Monitor Genzyme
  More Information

No publications provided

Responsible Party: Genzyme
ClinicalTrials.gov Identifier: NCT01736150     History of Changes
Other Study ID Numbers: SVCARB03808
Study First Received: November 26, 2012
Last Updated: November 26, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Genzyme:
Hemodialysis

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

ClinicalTrials.gov processed this record on June 18, 2013