Trial · NCT04495608
Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fluconazole in Hypercalcicuric Patients With Increased 1.25(OH) 2D Levels
NCT04495608, Phase 2, Completed, Hospices Civils de Lyon
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fluconazole in Hypercalcicuric Patients With Increased 1.25(OH) 2D Levels. Trials, record NCT04495608. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04495608
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fluconazole in Hypercalcicuric Patients With Increased 1.25(OH) 2D Levels
- NCT number
- NCT04495608
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- Hospices Civils de Lyon
- Conditions
- Nephrolithiasis, Nephrocalcinosis, Hypercalciuria
- Interventions
- Fluconazole, Placebo
- First posted
- 2020-08-03
- Last updated
- 2024-07-12
- Other registries' IDs
- eudract:2020-003011-97
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients with normalization of calciuria | Baseline (V1) and 18 weeks of treatment (V7) | Proportion of patients with normalization of 24-hour calciuria (≤ 0.1 mmol/kg/d) between Baseline (V1) and W18 (V7), or with a relative change of 30% of 24-hour calciuria between Baseline (V1) and W18 (V7) for patients who still have at W18 a 24-hour calciuria\> 0.1mmol/kg/d. |
| Secondary | Evolution over time of the calcium/phosphate metabolism (serum and urines dosages) | Baseline (V1), 18 weeks of treatment (V7) | Serum: calcium, ionized calcium, phosphate, magnesium, PTH, 25-OH-D, 1,25(OH)2D, 24-25 (OH)2 D, 25-OH-D:24-25(OH)2D ratio, total alkaline phosphatase. |
| Secondary | Serum creatinine | Baseline (V1), 18 weeks of treatment (V7) | Evolution of renal function |
| Secondary | number of lithiasis, nephrocalcinosis | Baseline (V1), 18 weeks of treatment (V7) | Evolution of renal function |
| Secondary | size of lithiasis, nephrocalcinosis | Baseline (V1), 18 weeks of treatment (V7) | Evolution of renal function |
| Secondary | Quantity of calcium intakes | 18 weeks | Anthropometry |
| Secondary | Quantity of sodium intakes | 18 weeks | Anthropometry |
| Secondary | Quantity of protein intakes | 18 weeks | Anthropometry |
| Secondary | bone alkaline phosphatases | 16 weeks | Bone evaluation with biomarkers |
| Secondary | FGF23 | 16 weeks | Bone evaluation with biomarkers |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35710560 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04495608
GET https://conductscience.org/api/trials/v1/NCT04495608/registered?page=2