Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5
NCT ID: NCT00452478
Last Updated: 2021-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
68 participants
INTERVENTIONAL
2007-05-22
2007-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Lanthanum carbonate
2250mg/day starting dose of lanthanum carbonate administered orally, in divided doses, with meals (500mg 750mg and 1000mg strengths)for 2 weeks; dose titration will occur based on serum phosphorus results not to exceed 3000mg/day.
Interventions
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Lanthanum carbonate
2250mg/day starting dose of lanthanum carbonate administered orally, in divided doses, with meals (500mg 750mg and 1000mg strengths)for 2 weeks; dose titration will occur based on serum phosphorus results not to exceed 3000mg/day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females of child bearing potential (FOCP) must be non-pregnant, non-lactating, have a negative serum beta human chorionic gonadotropin (HCG) test, and agree to comply with any applicable contraceptive requirements of the protocol.
* Subjects on a stable phosphate binder dose (defined as no change in medication or dosage for at least the one month prior to screening) with a serum phosphorus level between greater than 1.78 and less than or equal to 2.43 mmol/L (5.5 and 7.5 mg/dL).
Exclusion Criteria
* Subjects with an intact parathyroid hormone (iPTH) level greater than 500 pg/mL, or a history of previous parathyroidectomy within 12 months of screening.
* Subjects with any significant bowel obstruction, active inflammatory bowel disease, gastrointestinal (GI) motility disorders, abnormal or irregular bowel motion, or a history of major GI surgery within the last 6 months will be excluded.
* Subjects receiving aluminium, magnesium, or combination therapy other than sevelamer hydrogen chloride (HCl) and calcium as a phosphate binder at the time of screening will be excluded.
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Landeskrankenhaus Feldkirch, Abteilung fur Nephrologie und dialyse
Feldkirch Tisis, , Austria
Krankenhaus Elisabethinen/Dialysestation
Linz, , Austria
Ziekenhuis Zuid Oost Limburg
Genk, , Belgium
Frederica Sygehus
Fredericia, , Denmark
Holbaek Sykehus
Holbæk, , Denmark
Sygehus Viborg
Viborg, , Denmark
Dialysezentrum Barmbek
Hamburg, , Germany
Dialysezentrum Heilbronn
Heilbronn, , Germany
Dialyse Leipzig
Leipzig, , Germany
Nephrologisches Zentrum Emsland
Lingen, , Germany
nephrologische Schwerpunktpraxis
Oldenburg, , Germany
diabetologische Schwerpunktpraxis
Villingen-Schwenningen, , Germany
University of Milan, San Paolo Hospital, Renal Division
Milan, , Italy
Gelre Ziekenhuizen
Apeldoorn, , Netherlands
Countries
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Other Identifiers
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2006-003364-64
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD405-403
Identifier Type: -
Identifier Source: org_study_id
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