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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01128179
First received: May 20, 2010
Last updated: June 16, 2014
Last verified: June 2013
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Drug: Lanthanum carbonate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Serum Phosphate Values at Week 12 (LOCF) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: November 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128179

Locations
France
Dr Pablo Urena Torres
Saint Ouen, Paris, France, 93400
Sponsors and Collaborators
Shire
  More Information

No publications provided by Shire

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01128179     History of Changes
Other Study ID Numbers: SPD405-703, 2009-016531-35
Study First Received: May 20, 2010
Results First Received: March 20, 2013
Last Updated: June 16, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 22, 2014