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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01128179
Recruitment Status : Completed
First Posted : May 21, 2010
Results First Posted : May 22, 2013
Last Update Posted : June 26, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Lanthanum carbonate Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo-controlled Study to Assess the Effect of Lanthanum Carbonate on Intact FGF23 in Normo-phosphataemic Subjects With Stage 3 Chronic Kidney Disease
Study Start Date : November 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Lanthanum carbonate Drug: Lanthanum carbonate
1000 mg in chewable tablets administered three times a day (for a total of 3000 mg/day) for 12 weeks
Other Name: Fosrenol/Foznol

Placebo Comparator: Placebo Drug: Placebo
Matching placebo chewable tablets administered 3 times a day for 12 weeks

Primary Outcome Measures :
  1. Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF) [ Time Frame: 12 Weeks ]
    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.

Secondary Outcome Measures :
  1. Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF) [ Time Frame: 12 Weeks ]
  2. Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF) [ Time Frame: 12 weeks ]
  3. Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF) [ Time Frame: 12 weeks ]
  4. Change From Baseline in Serum Phosphate Values at Week 12 (LOCF) [ Time Frame: 12 weeks ]
  5. Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF) [ Time Frame: 12 weeks ]
  6. Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF) [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Subjects meeting all of the criteria listed below may be included in the study:

  1. ≥18 years old.
  2. Male, or non-pregnant, non-lactating females who agree to comply with any applicable contraceptive requirements of the protocol.
  3. Been in the care of a physician for CKD for >2 months, and are not expected to begin dialysis for at least 6 months.
  4. Screening serum c-terminal FGF23 > 50.0RU/mL.
  5. Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the MDRD formula.
  6. Normal serum phosphate (0.808-1.55mmol/L).
  7. Endogenous 25-hydroxy Vitamin D levels >20ng/mL.
  8. Adequate protein diet (includes 2-3 portions of protein-rich food per day).
  9. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
  10. Ability to provide written, signed, and dated (personally) informed consent to participate in the study.

Exclusion Criteria

  1. Vitamin D supplementation required.
  2. Compounds containing calcium, phosphate, aluminium or magnesium required.
  3. Acute renal failure.
  4. Rapidly progressing glomerulonephritis.
  5. Vegetarian diet.
  6. Known allergy to iodine.
  7. 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.
  8. 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).
  9. 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.
  10. Life-threatening malignancy or current multiple myeloma.
  11. Known to be Human Immunodeficiency Virus (HIV) positive.
  12. History of poor compliance with diet or medication that in the Investigator's opinion may interfere with adherence to the protocol.
  13. History of alcohol or other substance abuse within 6 months prior to screening.
  14. Subjects must not have used another investigational medicinal product or taken part in a clinical trial within the last 30 days prior to enrolment.
  15. Subjects who have previously been enrolled into this study and subsequently withdrawn.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01128179

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Dr Pablo Urena Torres
Saint Ouen, Paris, France, 93400
Sponsors and Collaborators
Publications of Results:
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Responsible Party: Shire Identifier: NCT01128179    
Other Study ID Numbers: SPD405-703
2009-016531-35 ( EudraCT Number )
First Posted: May 21, 2010    Key Record Dates
Results First Posted: May 22, 2013
Last Update Posted: June 26, 2014
Last Verified: June 2013
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency