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Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Myles S. Wolf, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438932
First received: February 20, 2007
Last updated: September 23, 2011
Last verified: September 2011

February 20, 2007
September 23, 2011
January 2007
January 2010   (final data collection date for primary outcome measure)
Fibroblast Growth Factor 23 (FGF-23) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Plasma FGF-23 was measured using c-terminal FGF23 assay.
FGF-23, PTH, 1,25D levels
Complete list of historical versions of study NCT00438932 on ClinicalTrials.gov Archive Site
24-hour Urinary Phosphate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
from 24-hr urine collections
Not Provided
Not Provided
Not Provided
 
Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease
Reduced Phosphate Intake in "Normo-Phosphatemic" Chronic Kidney Disease Patients

The purpose of this study is to learn more about how the kidneys control the blood levels of phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.

Phosphorus is a mineral found in dairy products, nuts, and meat that is essential for bone health and many other important functions inside the body's cells. The kidneys are responsible for keeping the blood levels of phosphorus normal. Healthy kidneys do this by spilling excess phosphorus into the urine. In patients with chronic kidney disease, the kidneys are unable to spill an adequate amount of phosphorus so that excess phosphorus can accumulate in the walls of blood vessels leading to heart disease, their leading cause of death. A recently discovered hormone called FGF-23 helps control the blood levels of phosphorus by "telling" the kidney how much phosphorus to spill in the urine. The purpose of this study is to learn more about how FGF-23 helps the kidneys control the blood levels of phosphorus. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Chronic Kidney Disease
  • Drug: Lanthanum Carbonate
    Lanthanum carbonate 1000mg 3x/day
  • Dietary Supplement: Low Phosphorus Diet
    Low phosphorus diet will consist of 800 mg of phosphorus per day.
  • Dietary Supplement: Unrestricted Phosphorus Diet
    Unrestricted diet will contain 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
    Other Name: Neutraphos
  • Drug: Placebo
    Lanthanum Carbonate placebo given three times a day with meals.
  • Active Comparator: Lanthanum Carbonate and Low Phosphorus Diet
    25% of subjects will receive binders plus a phosphate restricted diet.
    Interventions:
    • Drug: Lanthanum Carbonate
    • Dietary Supplement: Low Phosphorus Diet
  • Active Comparator: Lanthanum Carbonate and Unrestricted Phosphorus Diet
    25% binders + unrestricted phosphate diet.
    Interventions:
    • Drug: Lanthanum Carbonate
    • Dietary Supplement: Unrestricted Phosphorus Diet
  • Active Comparator: Placebo and Low Phosphorus Diet
    25% placebo + phosphate restricted diet.
    Interventions:
    • Dietary Supplement: Low Phosphorus Diet
    • Drug: Placebo
  • Active Comparator: Placebo and Unrestricted Phosphorus Diet
    25% placebo + unrestricted phosphate diet.
    Interventions:
    • Dietary Supplement: Unrestricted Phosphorus Diet
    • Drug: Placebo
Isakova T, Gutiérrez OM, Smith K, Epstein M, Keating LK, Jüppner H, Wolf M. Pilot study of dietary phosphorus restriction and phosphorus binders to target fibroblast growth factor 23 in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Feb;26(2):584-91. Epub 2010 Jul 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • subjects with stage 3a, 3b and 4 CKD
  • subjects have to be aged 18 years or older
  • subjects have to have normal serum phosphate levels (< 4.6 mg/dl)
  • subjects have to have sufficient 25-OH Vit0amin D levels (≥ 20 ng/ml)

Exclusion Criteria:

  • subjects with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period
  • subjects expected to require dialysis initiation within the follow up period
  • subjects with hyperphosphatemia > 4.6 mg/dL
  • subjects with any previous or current treatment with phosphate binders or active vitamin D (doxercalciferol or calcitriol)
  • subjects with malnutrition, defined as a serum albumin < 3.0 mg/dl, in order to avoid worsening protein-malnutrition status during the restricted study period since phosphate restricted diets are also low in protein
  • subjects with chronic gastrointestinal diseases that could impede their absorptive ability such as Crohn's disease, ulcerative colitis and sprue
  • subjects 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
  • subjects with anemia, defined as a hematocrit <27% at the screening visit
  • subjects wht have been hospitalization within the previous 4 weeks
  • subjects who are pregnant
  • subjects who are breastfeeding mothers
  • subjects with primary hypoparathyroidism
  • subjects with primary hyperparathyroidism
  • subjects with previous subtotal parathyroidectomy
  • subjects with previous outpatient counseling by a renal nutritionist
  • subjects who are unable to independently provide written informed consent - prisoners, mentally incompetent, minors
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00438932
2005P000486
Yes
Myles S. Wolf, Massachusetts General Hospital
Massachusetts General Hospital
Shire
Principal Investigator: Myles Wolf, MD, MMSc Univesity of Miami Miller School of Medicine
Principal Investigator: Harald Jueppner, MD Massachusetts General Hospital
Massachusetts General Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP