Role Of Phosphorus And FGF 23 In Patients With Dent Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dent Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dent Disease Intervention

Dent Disease subjects will receive 2 week supplementation with phosphorus

Group Type EXPERIMENTAL

Phosphorus Supplement

Intervention Type DRUG

250 mg po qid

Kidney Stone subjects

Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus

Group Type EXPERIMENTAL

Phosphorus Supplement

Intervention Type DRUG

250 mg po qid

Dent Disease Observation

Dent disease subjects will not get phosphorus

Group Type PLACEBO_COMPARATOR

Observation

Intervention Type OTHER

Baseline blood and urine measurements only

Interventions

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Phosphorus Supplement

250 mg po qid

Intervention Type DRUG

Observation

Baseline blood and urine measurements only

Intervention Type OTHER

Other Intervention Names

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K-phos neutral

Eligibility Criteria

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Inclusion Criteria

Patients will be recruited from those in the RKSC Dent Registry

1. Diagnostic criteria for Dent disease Observational arm include:

1. \<18 years old
2. 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
3. 1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL1.
2. Diagnostic criteria for Dent disease Intervention arm include:

1. \>18 years old
2. 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
3. 1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL1.
3. Idiopathic calcium nephrolithiasis with renal phosphate leak

1. Male patients \> 18 years old
2. History of symptomatic calcium oxalate or calcium phosphate stone, hypercalciuria (\>250 mg/24 hrs), renal phosphate leak (TMP/GFR \<2.07 mg/dl)
4. Idiopathic calcium nephrolithiasis without renal phosphate leak

1. Male patients \> 18 years old
2. 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

1. 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.

Eligible Sex

MALE

Accepts Healthy Volunteers

No