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Completed

NCT Number: NCT01002872

The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease

The aim of the study is to assess the effects of the drug lanthanum carbonate (a phosphorus binder drug) on c-terminal and on FGF23 levels in patients with Chronic Kidney Disease (CKD).

Targeting FGF23 measurement in CKD patients may impact both the progression of kidney disease and patient mortality.

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Key information

Conditions

Metabolic Bone Disease Bone Diseases Bone Diseases, Metabolic Hyperphosphatemia Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

About this study

This is a double blind randomized placebo controlled pilot study. Subjects with Chronic Kidney Disease ( CKD) stages 3-5 who are not undergoing renal replacement therapy and have not been started on phosphate binders will be randomized to either lanthanum carbonate 1500 mg daily or placebo for a 60 day treatment period. Patient doses will be increased up to a maximum dose of 3000 mg if the serum phosphate is greater than 5.5 mg/dL.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and non-pregnant females ages 18 years of age or older
  • Estimated glomerular filtration rate (GFR) between 15-60 ml/min/1.73m
  • Serum phosphate > 3.5 mg/dL
  • Fibroblast growth factor 2 (FGF2) > 100 relative units per milliliter (RU/mL)
  • Corrected serum calcium >8.0mg/dL

Exclusion criteria

  • Current use of a phosphate binder
  • Corrected serum calcium <8.0mg/dL
  • Current use of prescription-based vitamin D therapy
  • Acute kidney injury in last 3 months
  • Significant GI disorder
  • History of allergic reaction or sensitivity to lanthanum carbonate
  • History of non compliance with visits or medications that preclude study compliance in the opinion of the investigator
  • Pregnant or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator

Treatment and study plan

Lanthanum Carbonate (Fosrenol)

Drug

Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill three times a day (TID) Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus <3.5mg/dL Reduce to 1 pill twice a day (BID). If Phosphorus >5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is <3.5mg/dL Reduce to 1 pill daily. If phosphorus >5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus <3.5mg/dL stop the drug If phosphorus is >5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner

Other names: Fosrenol

Placebo

Drug

Initial dose of placebo will be 1 pill three times a day

Other names: sugar pill

Primary outcomes

  1. Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline

    Time frame: Baseline, 60 days

    Mean change from baseline of FGF23 in subjects treated with Lanthanum Carbonate verse placebo at 60 days

Secondary outcomes

  1. Calcium Mean Change From Baseline

    Time frame: Baseline, 60 days

    Mean change from baseline Calcium level at 60 days

  2. Serum Phosphate Mean Change From Baseline

    Time frame: Baseline, 60 days

    Mean change from baseline serum phosphate at 60 days

  3. Change From Baseline Serum Parathyroid Hormone

    Time frame: Baseline, 60 days

    Change from baseline serum parathyroid hormone at 60 days

  4. 1,25 Dihydroxyvitamin D 3 Mean Change From Baseline

    Time frame: Baseline, 60 days

    Mean change from baseline 1,25 dihydroxyvitamin D 3 at 60 days

  5. 25 Hydroxyvitamin D Mean Change From Baseline

    Time frame: Baseline, 60 days

    Mean change from baseline 25 hydroxyvitamin D at 60 days

  6. Serum Alkaline Phosphatase Mean Change From Baseline

    Time frame: Baseline, 60 days

    Mean change from baseline serum alkaline phosphatase at 60 days

  7. Serum Osteocalcin Mean Change From Baseline

    Time frame: Baseline, 60 days

    Mean change from baseline serum osteocalcin at 60 days

  8. 24 Hour Urine Phosphate Mean Change From Baseline

    Time frame: Baseline, 60 days

    Mean change from baseline 24 hour urine phosphate at 60 days

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

  • Shire

Registry information

Official study title

The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 (FGF23 ) in Chronic Kidney Disease

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 28, 2009
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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