Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5

Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00452478
• Other study ID #: SPD405-403
• Secondary ID: 2006-003364-64
• Status: Terminated
• Phase: Phase 4
• Start date: May 22, 2007
• Est. completion date: December 10, 2007

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: December 10, 2007
• Est. primary completion date: December 10, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Feldkirch, Abteilung fur Nephrologie und dialyse	Feldkirch Tisis
Austria	Krankenhaus Elisabethinen/Dialysestation	Linz
Belgium	Ziekenhuis Zuid Oost Limburg	Genk
Denmark	Frederica Sygehus	Fredericia
Denmark	Holbaek Sykehus	Holbaek
Denmark	Sygehus Viborg	Viborg
Germany	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
Italy	University of Milan, San Paolo Hospital, Renal Division	Milan
Netherlands	Gelre Ziekenhuizen	Apeldoorn

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Germany,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 weeks
Secondary	The maintenance of mean serum phosphorus levels following treatment with 2250 mg/day of Fosrenol		at Week 2 compared to baseline
Secondary	Biochemical and haematological parameters		measured throughout the study
Secondary	Assess safety & tolerability		Throughout the study