Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW)
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
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
Treatments tested in this trial
- VX-407
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov