Role Of Phosphorus And FGF 23 In Patients With Dent Disease

Mayo Clinic1 site in 1 country30 target enrollmentSeptember 2014

ConditionsDent Disease

InterventionsPhosphorus Supplement Observation

DrugsPhosphorus Supplement

Overview

Phase: Phase 1
Intervention: Phosphorus Supplement
Conditions: Dent Disease
Sponsor: Mayo Clinic
Enrollment: 30
Locations: 1
Primary Endpoint: Change in Urine Total Protein
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Patients with Dent disease have suppressed levels of FGF 23 which contributes to hypercalciuria, kidney stones, nephrocalcinosis and renal failure. Supplementation with phosphorus may reduce hypercalciuria.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

January 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

John Lieske

M.D.

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•Patients will be recruited from those in the RKSC Dent Registry
•Diagnostic criteria for Dent disease Observational arm include:
•\<18 years old
•LMWP (at least 5 times above the upper limit of normal) and at least 1 of the following criteria:
•Hypercalciuria,
•Kidney stones,
•Nephrocalcinosis,
•Hypophosphatemia,
•Renal phosphate leak,
•Aminoaciduria,

Exclusion Criteria

•Exclusion for Dent disease include: primary or secondary hyperparathyroidism, hyperthyroidism, chronic diarrhea states; intake of thiazide diuretics, glucocorticoids, or estrogens within one month of the study.
•Exclusion criteria for calcium stone formers include: primary or secondary hyperparathyroidism, hyperthyroidism, estimated GFR \<40 ml/mn/1.73m2, chronic diarrhea states; intake of thiazide diuretics, glucocorticoids, or estrogens within one month of the study.
•Exclusion criteria include history of symptomatic or asymptomatic kidney stone disease; primary or secondary hyperparathyroidism; estimated GFR \<40 ml/min/1.73m2, chronic diarrhea states; intake of thiazide diuretics, glucocorticoids, or estrogens within one month of the study.