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Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5
This study has been terminated.
( This study was stopped by the sponsor based on a non-safety related corporate decision )
First Received: March 23, 2007   Last Updated: December 18, 2007   History of Changes
Sponsored by: Shire Pharmaceutical Development
Information provided by: Shire Pharmaceutical Development
ClinicalTrials.gov Identifier: NCT00452478
  Purpose

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.


Condition Intervention Phase
Kidney Diseases
Drug: Lanthanum carbonate
Phase IV

MedlinePlus related topics: Dialysis Kidney Failure
Drug Information available for: Lanthanum Carbonate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:
  • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The maintenance of mean serum phosphorus levels following treatment with 2250 mg/day of Fosrenol [ Time Frame: at Week 2 compared to baseline ] [ Designated as safety issue: No ]
  • Biochemical and haematological parameters [ Time Frame: measured throughout the study ] [ Designated as safety issue: No ]
  • Assess safety & tolerability [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 68
Study Start Date: May 2007
Study Completion Date: December 2007
Arms Assigned Interventions
1: Experimental 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452478

Locations
Austria
Landeskrankenhaus Feldkirch, Abteilung fur Nephrologie und dialyse
Feldkirch Tisis, Austria, A-6807
Krankenhaus Elisabethinen/Dialysestation
Linz, Austria, A-4010
Belgium
Ziekenhuis Zuid Oost Limburg
Genk, Belgium, 3600
Denmark
Sygehus Viborg
Viborg, Denmark, 88 00
Holbaek Sykehus
Holbaek, Denmark, DK-4300
Frederica Sygehus
Fredericia, Denmark, 7000
Germany
nephrologische Schwerpunktpraxis
Oldenburg, Germany, 26127
diabetologische Schwerpunktpraxis
Villingen-Schwenningen, Germany, 78054
Dialysezentrum Heilbronn
Heilbronn, Germany, 74076
Nephrologisches Zentrum Emsland
Lingen, Germany, 49808
Dialysezentrum Barmbek
Hamburg, Germany, 22297
Dialyse Leipzig
Leipzig, Germany, 04178
Italy
University of Milan, San Paolo Hospital, Renal Division
Milan, Italy
Netherlands
Gelre Ziekenhuizen
Apeldoorn, Netherlands, 7334 DZ
Sponsors and Collaborators
Shire Pharmaceutical Development
Investigators
Principal Investigator: Mario Cozzolino, MD, PhD Renal Physician
  More Information

No publications provided

Responsible Party: Shire Pharmaceutical ( Timothy Whitaker, M.D. )
Study ID Numbers: SPD405-403
Study First Received: March 23, 2007
Last Updated: December 18, 2007
ClinicalTrials.gov Identifier: NCT00452478     History of Changes
Health Authority: Austria:AGES-PharmMed LCM;   Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment;   Denmark: Danish Medicines Agency;   France: Afssaps - French Health Products Safety Agency;   Germany:BfArM;   Ireland: Irish Medicines Board;   Italy: The Italian Medicines Agency;   Netherlands: Medicines Evaluation Board (MEB);   Spain: Spanish Agency of Medicines;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Shire Pharmaceutical Development:
Hyperphosphataemia

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hyperphosphatemia
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009