N/A
N=16
Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT00438932 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: Fibroblast Growth Factor 23 (FGF-23) — 162.695; 297; 188.975; 143.7675 RU/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lanthanum Carbonate (Drug); Low Phosphorus Diet (Dietary_supplement); Unrestricted Phosphorus Diet (Dietary_supplement); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fibroblast Growth Factor 23 (FGF-23) |
162.695; 297; 188.975; 143.7675 | — |
| SECONDARY 24-hour Urinary Phosphate |
150.4; 382.725; 346.8; 830.25 | — |
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.
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 with any previous or current treatment with phosphate binders or active vitamin D (doxercalciferol or calcitriol)
- subjects with malnutrition, defined as a serum albumin 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
Data sourced from ClinicalTrials.gov (NCT00438932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.