- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00438932
Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease
September 23, 2011 updated by: Myles S. Wolf, Massachusetts General Hospital
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Lanthanum Carbonate and Low Phosphorus Diet
25% of subjects will receive binders plus a phosphate restricted diet.
|
Lanthanum carbonate 1000mg 3x/day
Low phosphorus diet will consist of 800 mg of phosphorus per day.
|
ACTIVE_COMPARATOR: Lanthanum Carbonate and Unrestricted Phosphorus Diet
25% binders + unrestricted phosphate diet.
|
Lanthanum carbonate 1000mg 3x/day
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 Names:
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ACTIVE_COMPARATOR: Placebo and Low Phosphorus Diet
25% placebo + phosphate restricted diet.
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Low phosphorus diet will consist of 800 mg of phosphorus per day.
Lanthanum Carbonate placebo given three times a day with meals.
|
ACTIVE_COMPARATOR: Placebo and Unrestricted Phosphorus Diet
25% placebo + unrestricted phosphate 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 Names:
Lanthanum Carbonate placebo given three times a day with meals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fibroblast Growth Factor 23 (FGF-23)
Time Frame: 2 weeks
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Plasma FGF-23 was measured using c-terminal FGF23 assay.
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
24-hour Urinary Phosphate
Time Frame: 2 weeks
|
from 24-hr urine collections
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Myles Wolf, MD, MMSc, Univesity of Miami Miller School of Medicine
- Principal Investigator: Harald Jueppner, MD, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (ACTUAL)
January 1, 2010
Study Completion (ACTUAL)
January 1, 2010
Study Registration Dates
First Submitted
February 20, 2007
First Submitted That Met QC Criteria
February 21, 2007
First Posted (ESTIMATE)
February 22, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
September 27, 2011
Last Update Submitted That Met QC Criteria
September 23, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005P000486
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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