Phase 2 Enrolling by Invitation

Atorvastatin

Repurposed Statin Combined with Alkaline Therapy in Pilot Study

Sponsor

Taipei Medical University

Trial Name

Atorvastatin + Sodium Bicarbonate Pilot

Start Date

2024

Est. Completion

2025-12

Participants

30

Location

Taipei, Taiwan

NCT ID

NCT05870007

Mechanism

Statin combined with acidosis correction to slow CKD progression in ADPKD

A small pilot study in Taiwan is testing whether atorvastatin (a common cholesterol drug) combined with sodium bicarbonate can slow kidney disease progression in ADPKD patients.

Background

Statins have shown mixed results in kidney disease research. This pilot study from Taipei Medical University takes a novel combination approach: pairing atorvastatin with sodium bicarbonate to address both cholesterol-mediated kidney damage and metabolic acidosis, which accelerates CKD progression. The rationale is that ADPKD patients often develop acidosis as kidney function declines, creating a vicious cycle.

How It Works

Atorvastatin inhibits HMG-CoA reductase (cholesterol synthesis) but also has pleiotropic effects: it reduces inflammation, oxidative stress, and fibrosis in kidney tissue. Sodium bicarbonate corrects metabolic acidosis, which independently slows CKD progression. The combination targets two separate mechanisms of kidney damage simultaneously.

Clinical Trial Details

This open-label pilot study (NCT05870007) enrolled 30 ADPKD patients by invitation. It compares atorvastatin alone versus atorvastatin + sodium bicarbonate. The small size means it's primarily assessing feasibility and safety signals rather than proving efficacy. Expected completion by end of 2025.

Why It's Promising

Both drugs are cheap, widely available, and well-understood. If the combination shows benefit, it could be quickly adopted as an adjunct therapy without waiting for novel drug approvals. This is particularly relevant for patients in countries without access to tolvaptan.

Limitations & Concerns

Very small study (n=30), open-label design (no blinding), and limited to a single center. Even positive results would require a much larger confirmatory trial. Statins alone have not shown clear benefit in prior PKD studies.

repurposed combination-therapy accessible

Disclaimer: This information is for educational purposes only and is not medical advice. Clinical trial information is based on publicly available data from ClinicalTrials.gov and published research. Consult your nephrologist before making treatment decisions.

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