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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00452478
First Posted: March 27, 2007
Last Update Posted: June 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shire
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shire:

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 ]

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 ]
  • Biochemical and haematological parameters [ Time Frame: measured throughout the study ]
  • Assess safety & tolerability [ Time Frame: Throughout the study ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Frederica Sygehus
Fredericia, Denmark, 7000
Holbaek Sykehus
Holbaek, Denmark, DK-4300
Sygehus Viborg
Viborg, Denmark, 88 00
Germany
Dialysezentrum Barmbek
Hamburg, Germany, 22297
Dialysezentrum Heilbronn
Heilbronn, Germany, 74076
Dialyse Leipzig
Leipzig, Germany, 04178
Nephrologisches Zentrum Emsland
Lingen, Germany, 49808
nephrologische Schwerpunktpraxis
Oldenburg, Germany, 26127
diabetologische Schwerpunktpraxis
Villingen-Schwenningen, Germany, 78054
Italy
University of Milan, San Paolo Hospital, Renal Division
Milan, Italy
Netherlands
Gelre Ziekenhuizen
Apeldoorn, Netherlands, 7334 DZ
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Mario Cozzolino, MD, PhD Renal Physician
  More Information

Responsible Party: Timothy Whitaker, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00452478     History of Changes
Other Study ID Numbers: SPD405-403
2006-003364-64 ( EudraCT Number )
First Submitted: March 23, 2007
First Posted: March 27, 2007
Last Update Posted: June 9, 2014
Last Verified: December 2007

Keywords provided by Shire:
Hyperphosphataemia

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