Role Of Phosphorus And FGF 23 In Patients With Dent Disease

Dent Disease Clinical Trial

Official title:

Role Of Phosphorus And FGF 23 In Patients With Dent Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016235
• Other study ID #: 13-004774
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2014
• Est. completion date: January 2019

Study information

• Verified date: March 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Dent Disease

Intervention

Drug:
• Phosphorus Supplement
250 mg po qid

Other:
• Observation
Baseline blood and urine measurements only

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Urine Total Protein	Urine protein tests detect and/or measure protein being released into the urine. Normal urine protein elimination is less than 150 mg/day	baseline, day 7

External Links

•   Mayo Clinic Clinical Trials