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A no-profit, open-label, phase II pilot study on the efficacy and safety of Alpelisib in patients with Dent 2 disease (ALPEDENT study)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514196-17-00
Acronym
ALPEDENT_OPBG_2024
Enrollment
4
Registered
2025-01-17
Start date
2025-03-14
Completion date
Unknown
Last updated
2025-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dent 2 disease

Brief summary

Improvement in the renal uptake of 99mTc-DMSA after 4 weeks of treatment (a p-value of ≤ 0.05 will be used to determine statistical significance).

Detailed description

Improvement of low-molecular weight proteinuria as assessed by changes urinary excretion of retinol-binding protein and beta-2 microglobulin after 4 weeks of treatment (a p-value of ≤ 0.05 will be used to determine statistical significance). − Improvement of the Fanconi syndrome as assessed by including 24-hour urine volume, urinary excretion of sodium, glucose, phosphate, amino acids, and changes in serum bicarbonate after 4 weeks of treatment (a p-value of ≤ 0.05 to determine statis sign)

Interventions

DRUGRENOCIS 1 mg kit for radiopharmaceutical preparation

Sponsors

Ospedale Pediatrico Bambino Gesu
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Improvement in the renal uptake of 99mTc-DMSA after 4 weeks of treatment (a p-value of ≤ 0.05 will be used to determine statistical significance).

Secondary

MeasureTime frame
Improvement of low-molecular weight proteinuria as assessed by changes urinary excretion of retinol-binding protein and beta-2 microglobulin after 4 weeks of treatment (a p-value of ≤ 0.05 will be used to determine statistical significance). − Improvement of the Fanconi syndrome as assessed by including 24-hour urine volume, urinary excretion of sodium, glucose, phosphate, amino acids, and changes in serum bicarbonate after 4 weeks of treatment (a p-value of ≤ 0.05 to determine statis sign)

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026