Role of Phosphorus and FGF 23 in Patients with Dent Disease

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

Study IDs

  • Site IRB:

    • Rochester, Minnesota: 13-004774
  • NCT ID:

    NCT02016235
  • Sponsor Protocol Number:

    RDCRN 6414

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Patients will be recruited from those in the RKSC Dent Registry, Diagnostic criteria for Dent disease include:
    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
    2. 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:
    1. primary or secondary hyperparathyroidism,
    2. hyperthyroidism,
    3. chronic diarrhea states,
    4. intake of thiazide diuretics,
    5. glucocorticoids, or
    6. estrogens within one month of the study.
  2. Exclusion criteria for calcium stone formers include:
    1. primary or secondary hyperparathyroidism,
    2. hyperthyroidism,
    3. estimated GFR <40 ml/mn/1.73m2,
    4. chronic diarrhea states,
    5. intake of thiazide diuretics,
    6. glucocorticoids, or
    7. estrogens within one month of the study.
  3. Exclusion criteria include:
    1. history of symptomatic or asymptomatic kidney stone disease,
    2. primary or secondary hyperparathyroidism,
    3. estimated GFR <40 ml/min/1.73m2,
    4. chronic diarrhea states,
    5. intake of thiazide diuretics,
    6. glucocorticoids, or
    7. estrogens within one month of the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Lieske, M.D.

Contact us for the latest status

Julie Olson R.N., CCRP

(507)538-5995

Olson.Julie@mayo.edu