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Role Of Phosphorus And FGF 23 In Patients With Dent Disease

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ClinicalTrials.gov Identifier: NCT02016235
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
John Lieske, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Dent Disease Drug: Phosphorus Supplement Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role Of Phosphorus And FGF 23 In Patients With Dent Disease
Study Start Date : September 2014
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Phosphorus

Arm Intervention/treatment
Experimental: Dent Disease patients
A. 1. LMWP (at least 5 times above the upper limit of normal) and at least 1 of the following criteria: 1. Hypercalriuria, 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 B. 1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL1.
Drug: Phosphorus Supplement
250 mg po qid
Other Name: K-phos neutral

Experimental: hypercalciuria w/ phosphate leak
A. Male patients >18 years old will be recruited from the stone clinics at Mayo Clinic and NY Harbor VA Medical Center B. Eligibility Criteria include: 1) History of a symptomatic calcium oxalate or calcium phosphate stone; 2) hypercalciuria (>250 mg/24 hrs); 3) renal phosphate leak (TMP/GFR <2.07 mg/dl)
Drug: Phosphorus Supplement
250 mg po qid
Other Name: K-phos neutral

Experimental: hypercalciuria w/out phosphate leak
A. Male patients >18 years old will be recruited from the stone clinics at Mayo Clinic and NY Harbor VA Medical Center B. Eligibility Criteria include: 1) History of a symptomatic calcium oxalate or calcium phosphate stone; 2) hypercalciuria (>250 mg/24 hrs); 3) (TMP/GFR <2.07 mg/dl)
Drug: Phosphorus Supplement
250 mg po qid
Other Name: K-phos neutral




Primary Outcome Measures :
  1. Change in 24 hr urine and serum after 2 weeks of phosphorus supplementation [ Time Frame: 6 months ]
    This study will measure the changes in a 24 hr urine supersaturation and serum after phosphorus is taken for two weeks to decrease stone formation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients will be recruited from those in the RKSC Dent Registry

    Diagnostic criteria for Dent disease include:

    A. 1. 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 B. 1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL1.

  2. 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)
  3. 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.
  2. 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.
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016235


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: John C Lieske, M.D. Mayo Clinic

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Responsible Party: John Lieske, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02016235     History of Changes
Other Study ID Numbers: 13-004774
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Keywords provided by John Lieske, Mayo Clinic:
Dent
Dents
Dent Disease
Phosphorus Supplements
FGF 23
Additional relevant MeSH terms:
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Dent Disease
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Metabolic Diseases