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Completed

NCT Number: NCT01736150

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Chronic Kidney Disease on Hemodialysis Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking Union Medical College Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug
  • 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.

Sevelamer carbonate

Drug
  • 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 names: Renvela

Primary outcomes

  1. Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous.

    Time frame: 8 weeks

  2. 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

Secondary outcomes

  1. Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol).

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study of Sevelamer Carbonate in CKD Patients on Hemodialysis

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 29, 2012
Registry last updated
Mar 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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