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Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW)

ConditionAutosomal Dominant Polycystic Kidney Disease (ADPKD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVertex Pharmaceuticals Incorporated

About this trial

The purpose of the study is to evaluate the effect of VX-407 on height-adjusted total kidney volume (htTKV), safety, tolerability, and pharmacokinetics (PK) of VX-407.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A pre-existing diagnosis of ADPKD as defined in the protocol

Willing and able to comply with scheduled visits and other study procedures

Participants with ADPKD with Mayo imaging classification (MIC) status of 1B (with htTKV ≥250 mL/m), 1C, 1D, or 1E confirmed by abdominal MRI obtained during screening

Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 25 milliliter per minute (mL/min)/1.73 square meter (m²)

Disqualifiers

History of kidney disease other than ADPKD that in the opinion of the investigator would independently impact the natural history of ADPKD

History of solid organ or bone marrow transplantation or nephrectomy

Ongoing renal replacement therapy or planning to start renal replacement therapy within 12 months of screening

Trial design

Design model

Single group

Treatments tested in this trial

  • VX-407

    Drug

    Tablets for oral administration.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: VX-407Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

htTKV on MRI Over Time

Time frame
Baseline up to End of Study (Week 52)

Secondary outcomes

1

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
From Day 1 up to Week 54
2

Maximum Observed Plasma Concentration (Cmax) of VX-407

Time frame
From Day 1 up to Week 52
3

Area Under the Concentration Versus Time Curve (AUC) of VX-407

Time frame
From Day 1 up to Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vertex Pharmaceuticals Incorporated

Lead sponsor

Source ClinicalTrials.gov
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