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Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00151918
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : June 9, 2014
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Brief Summary:
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: Lanthanum carbonate Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Open Label, Randomized, Parallel Group Pilot Study to Assess the Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
Study Start Date : January 2005
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Pre-dialysis serum phosphate level at 8 weeks

Secondary Outcome Measures :
  1. Serum calcium and calcium-phosphate product
  2. Average daily pill burden
  3. Treatment emergent adverse events
  4. Patient satisfaction with treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients receiving haemodialysis for ESRD
  • Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months

Exclusion Criteria:

  • Pregnant or lactating women
  • Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
  • Patients who are HIV+
  • Patients with any significant bowel obstruction, active inflammatory bowel disease, GI motility disorders, or a history of major GI surgery within the last 6 months
Layout table for additonal information Identifier: NCT00151918    
Other Study ID Numbers: SPD405-310
2004-001608-11 ( EudraCT Number )
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: June 9, 2014
Last Verified: September 2007
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic