Phase 2 N=30 Treatment

Role Of Phosphorus And FGF 23 In Patients With Dent Disease

Dent Disease

Bottom Line

View on ClinicalTrials.gov: NCT02016235 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Change in Urine Total Protein — 1681; 59 mg/day

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Phosphorus Supplement (Drug); Observation (Other)
Age: Pediatric, Adult, Older Adult
Sex: Male
Sponsor: Mayo Clinic
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Urine Total Protein	1681; 59	—

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.

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: 1. Hypercalciuria, 2. Kidney stones, 3. Nephrocalcinosis, 4. Hypophosphatemia, 5. Renal phosphate leak, 6. Aminoaciduria, 7. Glucosuria without diabetes mellitus, 8. Hematuria, 9. Renal insufficiency, 10. Family history with x-linked inheritance or
1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL1.
Idiopathic calcium nephrolithiasis with renal phosphate leak
Male patients > 18 years old
History of symptomatic calcium oxalate or calcium phosphate stone, hypercalciuria (>250 mg/24 hrs), renal phosphate leak (TMP/GFR 18 years old
History of symptomatic calcium oxalate or calcium phosphate stone, hypercalciuria (>250 mg/24 hrs), renal phosphate leak (TMP/GFR <2.07 mg/dl)

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02016235). 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.