Phase 2
Completed N=30
Role Of Phosphorus And FGF 23 In Patients With Dent Disease
Source: ClinicalTrials.gov NCT02016235 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Change in Urine Total Protein — 1681; 59 mg/day
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Urine Total Protein |
1681; 59 | — |
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.
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. Informational only — not medical advice.