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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00151931 |
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Date of registration:
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07/09/2005 |
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Primary sponsor: |
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Public title:
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Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis
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Scientific title:
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A Multi-Centre, Open-Label Study Assessing the Efficacy and Tolerability of Lanthanum Carbonate in the Reduction of Serum Phosphate Levels in End Stage Renal Disease Patients Receiving Dialysis |
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Date of first enrolment:
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May 2004 |
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Target sample size:
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456 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00151931 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Dr. A Hutchison |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Nephrology, Manchester Royal Infirmary |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males and females of childbearing potential agree to take adequate precautions to
prevent contraception
- Patients diagnosed with ESRD must have been receiving a stable dialysis regimen for
chronic renal failure for the 2 consecutive months prior to enrollment in the study
- Patient requires treatment for hyperphosphataemia
Exclusion Criteria:
- Pregnant or lactating women
- Patients who continue to require treatment with compounds containing calcium,
aluminum or magnesium
- Patients with clinically significant uncontrolled concurrent illness, a
life-threatening malignancy or current multiple myeloma
- Patients who are HIV+
- Patients with any significant gastrointestinal surgery or disorders
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney Failure, Chronic
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Intervention(s)
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Drug: Lanthanum carbonate
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Primary Outcome(s)
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Pre-dialysis serum phosphate levels at 3, 5 and 12 weeks
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Secondary Outcome(s)
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PTH, serum calcium and calcium-phosphorus product
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Treatment emergent adverse events
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Secondary ID(s)
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SPD405-313
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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