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

NCT ID: NCT00438932

Last Updated: 2011-09-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Lanthanum Carbonate and Low Phosphorus Diet

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

Group Type ACTIVE_COMPARATOR

Lanthanum Carbonate

Intervention Type DRUG

Lanthanum carbonate 1000mg 3x/day

Low Phosphorus Diet

Intervention Type DIETARY_SUPPLEMENT

Low phosphorus diet will consist of 800 mg of phosphorus per day.

Lanthanum Carbonate and Unrestricted Phosphorus Diet

25% binders + unrestricted phosphate diet.

Group Type ACTIVE_COMPARATOR

Lanthanum Carbonate

Intervention Type DRUG

Lanthanum carbonate 1000mg 3x/day

Unrestricted Phosphorus Diet

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo and Low Phosphorus Diet

25% placebo + phosphate restricted diet.

Group Type ACTIVE_COMPARATOR

Low Phosphorus Diet

Intervention Type DIETARY_SUPPLEMENT

Low phosphorus diet will consist of 800 mg of phosphorus per day.

Placebo

Intervention Type DRUG

Lanthanum Carbonate placebo given three times a day with meals.

Placebo and Unrestricted Phosphorus Diet

25% placebo + unrestricted phosphate diet.

Group Type ACTIVE_COMPARATOR

Unrestricted Phosphorus Diet

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo

Intervention Type DRUG

Lanthanum Carbonate placebo given three times a day with meals.

Interventions

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Lanthanum Carbonate

Lanthanum carbonate 1000mg 3x/day

Intervention Type DRUG

Low Phosphorus Diet

Low phosphorus diet will consist of 800 mg of phosphorus per day.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Lanthanum Carbonate placebo given three times a day with meals.

Intervention Type DRUG

Other Intervention Names

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Neutraphos

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Myles S. Wolf

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Myles Wolf, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Univesity of Miami Miller School of Medicine

Harald Jueppner, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20631407 (View on PubMed)

Other Identifiers

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2005P000486

Identifier Type: -

Identifier Source: org_study_id