Fibroblast Growth Factor-23 (FGF23) Reduction in Predialysis Chronic Kidney Disease (CKD)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Myles Wolf, University of Miami
ClinicalTrials.gov Identifier:
NCT00843349
First received: February 12, 2009
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

The investigators would like to study the role of phosphorus metabolism in the development of certain hormonal problems in people with chronic kidney disease (CKD). More specifically, the goals of the research are (1) to understand the cause of hyperparathyroidism - a hormone problem that often develops in patients who have kidney disease and (2) to test whether decreasing phosphorus intake could help improve or prevent hyperparathyroidism.


Condition Intervention
Kidney Disease
Drug: Lanthanum Carbonate
Other: 900 mg Phosphate Diet
Drug: LC Placebo
Other: Ad Libitum Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Fibroblast Growth Factor-23 Reduction in Predialysis Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels [ Time Frame: Week 0 - 12 ] [ Designated as safety issue: No ]
    Nonfasting blood was assessed over a period of 12 weeks. The primary endpoint was percentage change in FGF-23 levels from baseline.

  • Percentage Changes in Parathyroid Hormone (PTH) Levels [ Time Frame: Week 0 - 12 ] [ Designated as safety issue: No ]
    Nonfasting blood was assessed over a period of 12 weeks. Endpoint was percentage changes in PTH levels from baseline.


Enrollment: 43
Study Start Date: July 2009
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 900 mg Phosphate Diet-LC
dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
Drug: Lanthanum Carbonate
Phosphorus binder
Other Name: Fosrenol
Other: 900 mg Phosphate Diet
Amount of phosphorus consumption in a day kept below 900 mg.
Active Comparator: Ad Libitum Diet-LC
no dietary intervention + phosphorus binder (Lanthanum Carbonate)
Drug: Lanthanum Carbonate
Phosphorus binder
Other Name: Fosrenol
Other: Ad Libitum Diet
Patients continued to eat their usual diet.
Active Comparator: 900 mg Phosphate Diet-LC Placebo
dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
Other: 900 mg Phosphate Diet
Amount of phosphorus consumption in a day kept below 900 mg.
Drug: LC Placebo
Placebo for Lanthanum Carbonate
Other Name: Placebo
Placebo Comparator: Ad Libitum Diet-LC Placebo
no dietary intervention + placebo
Drug: LC Placebo
Placebo for Lanthanum Carbonate
Other Name: Placebo
Other: Ad Libitum Diet
Patients continued to eat their usual diet.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • We will include stage 3a, 3b and 4 CKD patients, aged 18 years or over with normal serum phosphate levels (≤ 4.6 mg/dl)

Exclusion Criteria:

  • Patients with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period
  • Patients expected to require dialysis initiation within the follow up period
  • Patients with hyperphosphatemia > 4.6 mg/dl
  • Patients with any previous or current treatment with phosphate binders or active vitamin D (doxercalciferol or calcitriol)
  • Malnutrition, defined as a serum albumin < 3.0 mg/dl
  • Patients with liver disease (ALT or AST > 100 U/L) or cholestasis (direct bilirubin > 1.0 mg/dl) because this can limit their ability to absorb fat soluble vitamins such as vitamin D
  • Anemia, defined as a hematocrit < 27% at the screening visit
  • Medical conditions impacting Pi metabolism—primary hyper- or hypoparathyroidism; Patients with previous subtotal parathyroidectomy; gastrointestinal malabsorption disorders such as Crohn's Disease, ulcerative colitis, celiac disease, or severe liver dysfunction;
  • Patients with outpatient counseling by a renal nutritionist within the previous 6 months
  • Hospitalization within the previous 4 weeks
  • Pregnancy or breastfeeding mothers
  • Patients unable to independently provide written informed consent - prisoners, mentally incompetent, minors
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00843349

Locations
United States, Florida
University of Miami Hospital
Miami, Florida, United States, 33136
Sponsors and Collaborators
Myles Wolf
Investigators
Principal Investigator: Myles Wolf, MD, MMSc University of Miami
  More Information

No publications provided by University of Miami

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Myles Wolf, Associate Professor of Medicine, Chief of Division of Nephrology and Hypertension, University of Miami
ClinicalTrials.gov Identifier: NCT00843349     History of Changes
Other Study ID Numbers: 20080536, R01DK076116
Study First Received: February 12, 2009
Results First Received: February 7, 2013
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Phosphorus
Fibroblast Growth Factor-23
Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014