NCT02016235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 23, 2020

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

4.3 years

First QC Date

December 6, 2013

Results QC Date

December 30, 2019

Last Update Submit

March 19, 2020

Conditions

Dent Disease

Keywords

DentDentsDent DiseasePhosphorus SupplementsFGF 23

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Dent Disease Intervention

EXPERIMENTAL

Dent Disease subjects will receive 2 week supplementation with phosphorus

Drug: Phosphorus Supplement

Kidney Stone subjects

EXPERIMENTAL

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

Drug: Phosphorus Supplement

Dent Disease Observation

PLACEBO COMPARATOR

Dent disease subjects will not get phosphorus

Other: Observation

Interventions

Phosphorus SupplementDRUG

250 mg po qid

Also known as: K-phos neutral
Dent Disease InterventionKidney Stone subjects
ObservationOTHER

Baseline blood and urine measurements only

Dent Disease Observation

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Dent Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Renal Tubular Transport, Inborn ErrorsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Results Point of Contact

Title
John C. Lieske, M.D.
Organization
Mayo Clinic
Lieske.John@mayo.edu
507-266-7960

Study Officials

  • John C Lieske, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 19, 2013

Study Start

September 1, 2014

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

March 23, 2020

Results First Posted

March 23, 2020

Record last verified: 2020-03

Locations

US(1)