Trial record 2 of 7 for:    "Dent disease"

Role Of Phosphorus And FGF 23 In Patients With Dent Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
John Lieske, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02016235
First received: December 6, 2013
Last updated: June 30, 2014
Last verified: December 2013
  Purpose

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 Intervention Phase
Dent Disease
Drug: Phosphorus Supplement
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role Of Phosphorus And FGF 23 In Patients With Dent Disease

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in 24 hr urine and serum after 2 weeks of phosphorus supplementation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 40
Study Start Date: September 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phosphorus Supplement Drug: Phosphorus Supplement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016235

Contacts
Contact: Barbara M Seide 800-270-4637 rarekidneystones@mayo.edu
Contact: Alicia M Meek 800-270-4637 rarekidneystones@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Barbara Siede         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Barbara M Seide    800-270-4637    rarekidneystones@mayo.edu   
Contact: Alicia M Meek    800-270-4637    rarekidneystones@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: John C Lieske, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: John Lieske, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02016235     History of Changes
Other Study ID Numbers: 13-004774
Study First Received: December 6, 2013
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Dent
Dents
Dent Disease
Phosphorus Supplements
FGF 23

Additional relevant MeSH terms:
Dent Disease
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Metabolic Diseases

ClinicalTrials.gov processed this record on August 27, 2014