Clinical trial NCT00452478: Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5
Official title: A Phase IV, Open-Label, Multi-Centre Trial Evaluating the Conversion From Standard Phosphate Binder Therapy to Fosrenol® in Chronic Kidney Disease Stage 5 Patients on Haemodialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Diseases
Keywords: Hyperphosphataemia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-03-27
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Percentage of subjects achieving serum phosphorus levels of less than or equal to 1.78 mmol/L (5.5 mg/dL) following treatment with Fosrenol at Week 12 compared to treatment with their previous phosphate binder therapy
timeFrame: 12 weeks
Secondary outcomes:
measure: The maintenance of mean serum phosphorus levels following treatment with 2250 mg/day of Fosrenol
timeFrame: at Week 2 compared to baseline
measure: Biochemical and haematological parameters
timeFrame: measured throughout the study
measure: Assess safety & tolerability
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Feldkirch Tisis
country: Austria
facility: Landeskrankenhaus Feldkirch, Abteilung fur Nephrologie und dialyse
city: Linz
country: Austria
facility: Krankenhaus Elisabethinen/Dialysestation
city: Genk
country: Belgium
facility: Ziekenhuis Zuid Oost Limburg
city: Fredericia
country: Denmark
facility: Frederica Sygehus
city: Holbaek
country: Denmark
facility: Holbaek Sykehus
city: Viborg
country: Denmark
facility: Sygehus Viborg
city: Hamburg
country: Germany
facility: Dialysezentrum Barmbek
city: Heilbronn
country: Germany
facility: Dialysezentrum Heilbronn
city: Leipzig
country: Germany
facility: Dialyse Leipzig
city: Lingen
country: Germany
facility: Nephrologisches Zentrum Emsland
city: Oldenburg
country: Germany
facility: nephrologische Schwerpunktpraxis
city: Villingen-Schwenningen
country: Germany
facility: diabetologische Schwerpunktpraxis
city: Milan
country: Italy
facility: University of Milan, San Paolo Hospital, Renal Division
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: