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

Phase 4

Terminated

• Conditions: Kidney Diseases
• Interventions: Drug: Lanthanum carbonate

• Registration Number: NCT00452478
• Lead Sponsor: Shire

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-23
• Study First Submitted QC: 2007-03-26
• Study First Posted: 2007-03-27
• Study Start: 2007-05-22
• Primary Completion: 2007-12-10
• Study Completion: 2007-12-10
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Lanthanum carbonate	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The maintenance of mean serum phosphorus levels following treatment with 2250 mg/day of Fosrenol	at Week 2 compared to baseline
Assess safety & tolerability	Throughout the study
Biochemical and haematological parameters	measured throughout the study

Trial Locations

Locations (14)

Ziekenhuis Zuid Oost Limburg; 🇧🇪 Genk, Belgium

Frederica Sygehus; 🇩🇰 Fredericia, Denmark

Sygehus Viborg; 🇩🇰 Viborg, Denmark

Dialysezentrum Heilbronn; 🇩🇪 Heilbronn, Germany

Dialyse Leipzig; 🇩🇪 Leipzig, Germany

nephrologische Schwerpunktpraxis; 🇩🇪 Oldenburg, Germany

diabetologische Schwerpunktpraxis; 🇩🇪 Villingen-Schwenningen, Germany

University of Milan, San Paolo Hospital, Renal Division; 🇮🇹 Milan, Italy

Gelre Ziekenhuizen; 🇳🇱 Apeldoorn, Netherlands

Landeskrankenhaus Feldkirch, Abteilung fur Nephrologie und dialyse; 🇦🇹 Feldkirch Tisis, Austria

Holbaek Sykehus; 🇩🇰 Holbaek, Denmark

Dialysezentrum Barmbek; 🇩🇪 Hamburg, Germany

Krankenhaus Elisabethinen/Dialysestation; 🇦🇹 Linz, Austria

Nephrologisches Zentrum Emsland; 🇩🇪 Lingen, Germany