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

NCT00452478 | Terminated Phase 4

• 2 other identifiers: SPD405-4032006-003364-64
• Study Type: interventional
• Target: 68
• Locations: 6 countries
• Sites: 14

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.

Conditions

Kidney Diseases

Keywords

Hyperphosphataemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  at Week 2 compared to baseline

• Biochemical and haematological parameters

  measured throughout the study

• Assess safety & tolerability

  Throughout the study

Study Arms (1)

1

EXPERIMENTAL

Drug: Lanthanum carbonate

Interventions

Lanthanum carbonate DRUG

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.

Also known as: FOSRENOL

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (14)

Landeskrankenhaus Feldkirch, Abteilung fur Nephrologie und dialyse

Feldkirch Tisis, A-6807, Austria

Location

Krankenhaus Elisabethinen/Dialysestation

Linz, A-4010, Austria

Location

Ziekenhuis Zuid Oost Limburg

Genk, 3600, Belgium

Location

Frederica Sygehus

Fredericia, 7000, Denmark

Location

Holbaek Sykehus

Holbæk, DK-4300, Denmark

Location

Sygehus Viborg

Viborg, 88 00, Denmark

Location

Dialysezentrum Barmbek

Hamburg, 22297, Germany

Location

Dialysezentrum Heilbronn

Heilbronn, 74076, Germany

Location

Dialyse Leipzig

Leipzig, 04178, Germany

Location

Nephrologisches Zentrum Emsland

Lingen, 49808, Germany

Location

nephrologische Schwerpunktpraxis

Oldenburg, 26127, Germany

Location

diabetologische Schwerpunktpraxis

Villingen-Schwenningen, 78054, Germany

Location

University of Milan, San Paolo Hospital, Renal Division

Milan, Italy

Location

Gelre Ziekenhuizen

Apeldoorn, 7334 DZ, Netherlands

Location

MeSH Terms

Conditions

Kidney Diseases; Hyperphosphatemia

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2007
• First Posted: March 27, 2007
• Study Start: May 22, 2007
• Primary Completion: December 10, 2007
• Study Completion: December 10, 2007
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

DE (6); DK (3); NL (1); AU (2); IT (1); BE (1)