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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lanthanum Carbonate
Low Phosphorus Diet
Unrestricted Phosphorus Diet
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease focused on measuring phosphate, phosphorus, FGF-23, PTH, 1,25D

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lanthanum Carbonate and Low Phosphorus Diet

Lanthanum Carbonate and Unrestricted Phosphorus Diet

Placebo and Low Phosphorus Diet

Placebo and Unrestricted Phosphorus Diet

Arm Description

25% of subjects will receive binders plus a phosphate restricted diet.

25% binders + unrestricted phosphate diet.

25% placebo + phosphate restricted diet.

25% placebo + unrestricted phosphate diet.

Outcomes

Primary Outcome Measures

Fibroblast Growth Factor 23 (FGF-23)
Plasma FGF-23 was measured using c-terminal FGF23 assay.

Secondary Outcome Measures

24-hour Urinary Phosphate
from 24-hr urine collections

Full Information

First Posted
February 20, 2007
Last Updated
September 23, 2011
Sponsor
Massachusetts General Hospital
Collaborators
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00438932
Brief Title
Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease
Official Title
Reduced Phosphate Intake in "Normo-Phosphatemic" Chronic Kidney Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
phosphate, phosphorus, FGF-23, PTH, 1,25D

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lanthanum Carbonate and Low Phosphorus Diet
Arm Type
Active Comparator
Arm Description
25% of subjects will receive binders plus a phosphate restricted diet.
Arm Title
Lanthanum Carbonate and Unrestricted Phosphorus Diet
Arm Type
Active Comparator
Arm Description
25% binders + unrestricted phosphate diet.
Arm Title
Placebo and Low Phosphorus Diet
Arm Type
Active Comparator
Arm Description
25% placebo + phosphate restricted diet.
Arm Title
Placebo and Unrestricted Phosphorus Diet
Arm Type
Active Comparator
Arm Description
25% placebo + unrestricted phosphate diet.
Intervention Type
Drug
Intervention Name(s)
Lanthanum Carbonate
Intervention Description
Lanthanum carbonate 1000mg 3x/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Low Phosphorus Diet
Intervention Description
Low phosphorus diet will consist of 800 mg of phosphorus per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Unrestricted Phosphorus Diet
Other Intervention Name(s)
Neutraphos
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lanthanum Carbonate placebo given three times a day with meals.
Primary Outcome Measure Information:
Title
Fibroblast Growth Factor 23 (FGF-23)
Description
Plasma FGF-23 was measured using c-terminal FGF23 assay.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
24-hour Urinary Phosphate
Description
from 24-hr urine collections
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myles Wolf, MD, MMSc
Organizational Affiliation
Univesity of Miami Miller School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harald Jueppner, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20631407
Citation
Isakova T, Gutierrez OM, Smith K, Epstein M, Keating LK, Juppner 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. doi: 10.1093/ndt/gfq419. Epub 2010 Jul 14.
Results Reference
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Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease

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