Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD

NCT01128179 | Completed Phase 2 Results

• 2 other identifiers: SPD405-7032009-016531-35
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)

  FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.

  12 Weeks

Secondary Outcomes (6)

• Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)

  12 Weeks

• Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)

  12 weeks

• Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)

  12 weeks

• Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)

  12 weeks

• Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)

  12 weeks

Study Arms (2)

Lanthanum carbonate

EXPERIMENTAL

Drug: Lanthanum carbonate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lanthanum carbonate DRUG

1000 mg in chewable tablets administered three times a day (for a total of 3000 mg/day) for 12 weeks

Also known as: Fosrenol/Foznol

Lanthanum carbonate

Placebo DRUG

Matching placebo chewable tablets administered 3 times a day for 12 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects meeting all of the criteria listed below may be included in the study:
• ≥18 years old.
• Male, or non-pregnant, non-lactating females who agree to comply with any applicable contraceptive requirements of the protocol.
• Been in the care of a physician for CKD for \>2 months, and are not expected to begin dialysis for at least 6 months.
• Screening serum c-terminal FGF23 \> 50.0RU/mL.
• Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the MDRD formula.
• Normal serum phosphate (0.808-1.55mmol/L).
• Endogenous 25-hydroxy Vitamin D levels \>20ng/mL.
• Adequate protein diet (includes 2-3 portions of protein-rich food per day).
• An understanding, ability, and willingness to fully comply with study procedures and restrictions.
• Ability to provide written, signed, and dated (personally) informed consent to participate in the study.

You may not qualify if:

• Vitamin D supplementation required.
• Compounds containing calcium, phosphate, aluminium or magnesium required.
• Acute renal failure.
• Rapidly progressing glomerulonephritis.
• Vegetarian diet.
• Known allergy to iodine.
• Clinically significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair subjects' ability to give informed consent or take part in or complete this clinical study.
• Cirrhosis or other clinically significant liver disease (aspartate transaminase (AST) or alanine transaminase (ALT) \>3 times the upper limit of normal or bilirubin \>2 times the upper limit of normal).
• Past (treated within the last 5 years) or present GI disorders including uncontrolled peptic ulcer, Crohn's disease (or other conditions where the integrity of the GI tract may be compromised), malignancy, or GI bleed within the last 6 months.
• Life-threatening malignancy or current multiple myeloma.
• Known to be Human Immunodeficiency Virus (HIV) positive.
• History of poor compliance with diet or medication that in the Investigator's opinion may interfere with adherence to the protocol.
• History of alcohol or other substance abuse within 6 months prior to screening.
• Subjects must not have used another investigational medicinal product or taken part in a clinical trial within the last 30 days prior to enrolment.
• Subjects who have previously been enrolled into this study and subsequently withdrawn.

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

Dr Pablo Urena Torres

Saint-Ouen, Paris, 93400, France

Location

Related Publications (2)

• Urena-Torres P, Prie D, Keddad K, Preston P, Wilde P, Wan H, Copley JB. Changes in fibroblast growth factor 23 levels in normophosphatemic patients with chronic kidney disease stage 3 treated with lanthanum carbonate: results of the PREFECT study, a phase 2a, double blind, randomized, placebo-controlled trial. BMC Nephrol. 2014 May 5;15:71. doi: 10.1186/1471-2369-15-71.

  PMID: 24885942 RESULT

• Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

  PMID: 40576086 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 21, 2010
• Study Start: December 6, 2010
• Primary Completion: April 16, 2012
• Study Completion: April 16, 2012
• Last Updated: June 9, 2021
• Results First Posted: May 22, 2013

Record last verified: 2021-05

Locations

FR (1)