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Clinical Trials/NCT02016235
NCT02016235CompletedPhase 1

Role Of Phosphorus And FGF 23 In Patients With Dent Disease

Mayo Clinic1 site in 1 country30 target enrollmentStarted: September 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Change in Urine Total Protein
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
Male
Accepts Healthy Volunteers
No

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,
  • •Glucosuria without diabetes mellitus,
  • •Renal insufficiency,
  • •Family history with x-linked inheritance or
  • •1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL
  • •Diagnostic criteria for Dent disease Intervention 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,
  • •Glucosuria without diabetes mellitus,
  • •Renal insufficiency,
  • •Family history with x-linked inheritance or
  • •1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL
  • •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 <2.07 mg/dl)
  • •Idiopathic calcium nephrolithiasis without 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 <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.

Arms & Interventions

Dent Disease Intervention

Experimental

Dent Disease subjects will receive 2 week supplementation with phosphorus

Intervention: Phosphorus Supplement (Drug)

Kidney Stone subjects

Experimental

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

Intervention: Phosphorus Supplement (Drug)

Dent Disease Observation

Placebo Comparator

Dent disease subjects will not get phosphorus

Intervention: Observation (Other)

Outcomes

Primary Outcomes

Change in Urine Total Protein

Time Frame: baseline, day 7

Urine protein tests detect and/or measure protein being released into the urine. Normal urine protein elimination is less than 150 mg/day

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

John Lieske

M.D.

Mayo Clinic

Study Sites (1)

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