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

Chronic Kidney Disease Clinical Trial

Official title:

Reduced Phosphate Intake in "Normo-Phosphatemic" Chronic Kidney Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438932
• Other study ID #: 2005P000486
• Status: Completed
• Phase: N/A
• First received: February 20, 2007
• Last updated: September 23, 2011
• Start date: January 2007
• Est. completion date: January 2010

Study information

• Verified date: September 2011
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Drug:
• Placebo
Lanthanum Carbonate placebo given three times a day with meals.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 F — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibroblast Growth Factor 23 (FGF-23)	Plasma FGF-23 was measured using c-terminal FGF23 assay.	2 weeks	No
Secondary	24-hour Urinary Phosphate	from 24-hr urine collections	2 weeks	No