Status:
TERMINATED
Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5
Lead Sponsor:
Shire
Conditions:
Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The main aim of this research study is to see if giving Fosrenol®, a chewable tablet, to patients on haemodialysis works as well as other treatments currently used to lower blood phosphorus levels.
Eligibility Criteria
Inclusion
- Male or female subjects greater than or equal to 18 years of age receiving a stable regimen of haemodialysis for chronic kidney disease (CKD) Stage 5 (defined as haemodialysis two or three times per week for at least two months prior to screening).
- 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
- Subjects with a corrected serum calcium level less than 2.1 mmol/L (8.5 mg/dL).
- 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.
Key Trial Info
Start Date :
May 22 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2007
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00452478
Start Date
May 22 2007
End Date
December 10 2007
Last Update
May 25 2021
Active Locations (14)
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1
Landeskrankenhaus Feldkirch, Abteilung fur Nephrologie und dialyse
Feldkirch Tisis, Austria, A-6807
2
Krankenhaus Elisabethinen/Dialysestation
Linz, Austria, A-4010
3
Ziekenhuis Zuid Oost Limburg
Genk, Belgium, 3600
4
Frederica Sygehus
Fredericia, Denmark, 7000