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

Condition(s) targeted: Kidney Diseases

Intervention: Lanthanum carbonate (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Shire Pharmaceutical Development

Official(s) and/or principal investigator(s):
Mario Cozzolino, MD, PhD, Principal Investigator, Affiliation: Renal Physician

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.

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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 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

Secondary outcome:

The maintenance of mean serum phosphorus levels following treatment with 2250 mg/day of Fosrenol

Biochemical and haematological parameters

Assess safety & tolerability

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Landeskrankenhaus Feldkirch, Abteilung fur Nephrologie und dialyse, Feldkirch Tisis A-6807, Austria

Krankenhaus Elisabethinen/Dialysestation, Linz A-4010, Austria

Ziekenhuis Zuid Oost Limburg, Genk 3600, Belgium

Sygehus Viborg, Viborg 88 00, Denmark

Holbaek Sykehus, Holbaek DK-4300, Denmark

Frederica Sygehus, Fredericia 7000, Denmark

nephrologische Schwerpunktpraxis, Oldenburg 26127, Germany

diabetologische Schwerpunktpraxis, Villingen-Schwenningen 78054, Germany

Dialysezentrum Heilbronn, Heilbronn 74076, Germany

Nephrologisches Zentrum Emsland, Lingen 49808, Germany

Dialysezentrum Barmbek, Hamburg 22297, Germany

Dialyse Leipzig, Leipzig 04178, Germany

University of Milan, San Paolo Hospital, Renal Division, Milan, Italy

Gelre Ziekenhuizen, Apeldoorn 7334 DZ, Netherlands

Starting date: May 2007
Ending date: December 2007
Last updated: December 18, 2007