Dent DiseasePhase 1/2NCT02016235
Role Of Phosphorus And FGF 23 In Patients With Dent Disease
A Phase 1/2 study testing Phosphorus Supplement and Observation in people with Dent Disease, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Dent Disease
- What is being tested?
- Phosphorus Supplement and Observation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jan 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- 1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL1.
- Diagnostic criteria for Dent disease Intervention arm include:
Show all 15Show fewer
- >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
- 1 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
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.
- Conditions
- Dent Disease
- Being tested
- Phosphorus Supplement, Observation
- Keywords
- Dent, Dents, Dent Disease, Phosphorus Supplements, FGF 23
- Medical subject headings
- Dent Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phosphorus SupplementDrug
Also called K-phos neutral
250 mg po qid
ObservationOther
Baseline blood and urine measurements only
| Study group | Role | What they receive |
|---|---|---|
| Dent Disease Intervention | Experimental | Dent Disease subjects will receive 2 week supplementation with phosphorus Receives: Drug: Phosphorus Supplement |
| Kidney Stone subjects | Experimental | Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus Receives: Drug: Phosphorus Supplement |
| Dent Disease Observation | Placebo comparator | Dent disease subjects will not get phosphorus Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startSep 2014
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dent DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Lieske, Mayo Clinic
- Investigators
- John C Lieske, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016235
- Sponsor's protocol ID
- 13-004774
- Status last verified
- Mar 2020
- First submitted
- 6 Dec 2013
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Reynolds CJ, Haskic Z, Seide BM, Romero MF, Goldfarb DS, Lieske JC, Beara-Lasic L. The Significance of Fibroblast Growth Factor 23 and 24,25-Dihydroxyvitamin D in Dent Disease Type 1. Clin J Am Soc Nephrol. 2026 Feb 27;21(5):811-21. doi: 10.2215/CJN.0000000978. Online ahead of print.
PubMed 41758568
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Phosphorus And FGF 23 In Patients With Dent Disease
- ClinicalTrials.gov ID
- NCT02016235
- Acronym / sponsor ID
- 13-004774
- Conditions
- Dent Disease
- Keywords
- Dent, Dents, Dent Disease, Phosphorus Supplements, FGF 23
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dent Disease Intervention | Experimental | Drug: Phosphorus SupplementDent Disease subjects will receive 2 week supplementation with phosphorus |
| Kidney Stone subjects | Experimental | Drug: Phosphorus SupplementKidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus |
| Dent Disease Observation | Placebo comparator | Other: ObservationDent disease subjects will not get phosphorus |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Patients will be recruited from those in the RKSC Dent Registry
- Diagnostic criteria for Dent disease Observational arm include:
- Diagnostic criteria for Dent disease Intervention arm include:
- Idiopathic calcium nephrolithiasis with renal phosphate leak
- Idiopathic calcium nephrolithiasis without renal phosphate leak
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phosphorus SupplementAlso: K-phos neutral250 mg po qid | Drug | Dent Disease Intervention, Kidney Stone subjects |
| ObservationBaseline blood and urine measurements only | Other | Dent Disease Observation |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41758568Reynolds CJ, Haskic Z, Seide BM, Romero MF, Goldfarb DS, Lieske JC, Beara-Lasic L. The Significance of Fibroblast Growth Factor 23 and 24,25-Dihydroxyvitamin D in Dent Disease Type 1. Clin J Am Soc Nephrol. 2026 Feb 27;21(5):811-21. doi: 10.2215/CJN.0000000978. Online ahead of print.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John C Lieske, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phosphorus Supplement and Observation in people with Dent Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urine Total Protein (time frame: baseline, day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02016235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.