Autosomal Dominant Polycystic Kidney Disease (ADPKD)Phase 2AGLOWNCT07161037
Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW)
A Phase 2 study testing VX-407 in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Vertex Pharmaceuticals Incorporated at 43 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- What is being tested?
- VX-407
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 43 sitesin 8 countries
- Study dates
- 19 Nov 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (m^2)
Who cannot join
- 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
- Other protocol defined Inclusion/Exclusion criteria will apply.
Trial locations and contacts
43 sites in 8 countries.
43 sites in 8 countries
United States26 sites
Alabama Kidney Research
Alabaster, Alabama, 35007
Emory School of Medicine - Renal Division
Atlanta, Georgia, 30322
University of Maryland Medical Center - General Clinical Research Center
Baltimore, Maryland, 21201
UAB Nephrology Research at CH19
Birmingham, Alabama, 35294
Tufts Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center - Nephrology
Boston, Massachusetts, 02215
UVM Medical Center - 1 South Prospect Street
Burlington, Vermont, 05401
UChicago Medicine - Duchossois Center for Advanced Medicine - Nephrology
Chicago, Illinois, 60637
Cleveland Clinic - Main Campus
Cleveland, Ohio, 44195
Renal Associates
Columbus, Georgia, 31904
Geisinger Clinic
Danville, Pennsylvania, 17822
University of Iowa Health Care Medical Center- Nephrology
Iowa City, Iowa, 52242
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Clinical & Translational Science Unit (CTSU) - Nephrology
Kansas City, Kansas, 66160
DaVita Kidney Care - Las Vegas
Las Vegas, Nevada, 89107
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Nephrology & Hypertension Associates, PC
Middlebury, Connecticut, 06762
University of Minnesota -Clinics and Surgery Center (CSC) - Endocrine Clinic
Minneapolis, Minnesota, 55455
Nephrology Clinical Trials Center
Nashville, Tennessee, 37232
Yale University - Yale Nephrology Clinical Research Clinic
New Haven, Connecticut, 06510
The Rogosin Kidney Center
New York, New York, 10021
General Nephrology Clinic - New York City
New York, New York, 10032
Perelman Center for Advanced Medicine - Nephrology
Philadelphia, Pennsylvania, 19104
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
UCSF Clinical Research Center at Parnassus
San Francisco, California, 94143
Swedish Center for Comprehensive Care
Seattle, Washington, 98104
United Kingdom6 sites
Queen Elizabeth Hospital Birmingham
Birmingham
King's College Hospital - Pulmonology
London
Royal Free Hospital - Nephrology
London
St George's Hospital London - Nephrology
London
Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital - Nephrology
Newcastle upon Tyne
Northern General Hospital
Sheffield
France3 sites
Centre Hospitalier Regional Universitaire (CHRU) Brest
Brest
Hopital Necker Enfants Malades - Neurology
Paris
Hopital Bretonneau
Tours
Belgium2 sites
Universite Catholique de Louvain - Nephrology
Brussels
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Nephrology
Leuven
Germany2 sites
Charité - Klinik für Nephrologie und Intensivmedizin der
Berlin
University Hospital Cologne (Koeln) - Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin
Cologne
About this study
Official title: A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-407 in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Have a Subset of PKD1 Gene Variants
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.
- Being tested
- VX-407
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-407Drug
Tablets for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| VX-407 | Experimental | Participants will receive VX-407 for up to 52 weeks. Receives: Drug: VX-407 |
What is being measured
The primary outcome is the main question the study is designed to answer.
htTKV on MRI Over Time
Measured: Baseline up to End of Study (Week 52)
Secondary outcomes (3)
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day 1 up to Week 54
Maximum Observed Plasma Concentration (Cmax) of VX-407
Measured: From Day 1 up to Week 52
Area Under the Concentration Versus Time Curve (AUC) of VX-407
Measured: From Day 1 up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start19 Nov 2025
- Primary completion22 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Studies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161037
- Sponsor's protocol ID
- VX24-407-101
- Other IDs
- 2024-517393-13-00
- Acronym
- AGLOW
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
Publications
Chen CY, Hadla M, Khambati I, Kashyap S, Westerfield V, Fedeles S, Besse W, Hopp K, Harris PC, Patel V, Chini E, Salih M, Barry MA, Chebib FT. Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease. Kidney360. 2026 Jul 1;7(7):1662-1676. doi: 10.34067/KID.0000001109. Epub 2025 Dec 12.
PubMed 41385299
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-407 in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Have a Subset of PKD1 Gene Variants
- ClinicalTrials.gov ID
- NCT07161037
- Acronym / sponsor ID
- AGLOW / VX24-407-101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 22 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VX-407 | Experimental | Drug: VX-407Participants will receive VX-407 for up to 52 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (m^2)
Key exclusion criteria (4 listed)
- 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
- Other protocol defined Inclusion/Exclusion criteria will apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VX-407Tablets for oral administration. | Drug | VX-407 |
Primary outcome
htTKV on MRI Over Time
Time frame: Baseline up to End of Study (Week 52)
3 secondary outcomes
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
Maximum Observed Plasma Concentration (Cmax) of VX-407
Time frame: From Day 1 up to Week 52
Area Under the Concentration Versus Time Curve (AUC) of VX-407
Time frame: From Day 1 up to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 41385299Chen CY, Hadla M, Khambati I, Kashyap S, Westerfield V, Fedeles S, Besse W, Hopp K, Harris PC, Patel V, Chini E, Salih M, Barry MA, Chebib FT. Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease. Kidney360. 2026 Jul 1;7(7):1662-1676. doi: 10.34067/KID.0000001109. Epub 2025 Dec 12.
- Individual participant dataSharing planned: No. Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
43 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VX-407 in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Vertex Pharmaceuticals Incorporated at 43 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, United Kingdom, France, Belgium, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
htTKV on MRI Over Time (time frame: Baseline up to End of Study (Week 52)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07161037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.