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:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00452478
First received: March 23, 2007
Last updated: June 6, 2014
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

No publications provided

Responsible Party: Timothy Whitaker, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00452478     History of Changes
Other Study ID Numbers: SPD405-403, 2006-003364-64
Study First Received: March 23, 2007
Last Updated: June 6, 2014
Health Authority: Austria:AGES-PharmMed LCM
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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:
Hyperphosphataemia

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

ClinicalTrials.gov processed this record on September 15, 2014