Metformin versus Tolvaptan in adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD): a phase 3a, independent, multi- centre, 2 parallel arms randomized controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517864-49-01

Acronym

AIFA-2016-02365060

Enrollment

150

Registered

2025-01-21

Start date

2020-09-08

Completion date

Unknown

Last updated

2025-09-12

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

Conditions

Autosomal Dominant Polycystic Kidney Disease

Brief summary

Primary outcome of the study is to evaluate the treatments difference (between Metformin and Tolvaptan) in annualized slope of eGFR (CKD-epi) for individual subjects will be calculated using an appropriate baseline and post-randomization assessment

Detailed description

The key secondary endpoint is the percent change from baseline in htTKV as measured by CT-scan at 12 and 24 months.

Interventions

DRUGJinarc 30 mg tablets + Jinarc 60 mg tablets

DRUGJinarc 15 mg tablets + Jinarc 45 mg tablets

DRUGJinarc 30 mg tablets + Jinarc 90 mg tablets

DRUGMETFORMIN

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Primary outcome of the study is to evaluate the treatments difference (between Metformin and Tolvaptan) in annualized slope of eGFR (CKD-epi) for individual subjects will be calculated using an appropriate baseline and post-randomization assessment	—

Secondary

Measure	Time frame
The key secondary endpoint is the percent change from baseline in htTKV as measured by CT-scan at 12 and 24 months.	—

Countries

Italy

Outcome results

None listed

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