Proteinuric Kidney DiseasePhase 2AMPLIFIEDNCT06794996
Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease With or Without Comorbidities
A Phase 2 study testing Inaxaplin in people with Proteinuric Kidney Disease, run by Vertex Pharmaceuticals Incorporated at 35 sites in United States.
Trial summary
The purpose of the study is to evaluate the efficacy, safety, and tolerability of Inaxaplin (IXP) in participants with proteinuric APOL1- mediated kidney disease (AMKD). Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Proteinuric Kidney Disease
- What is being tested?
- Inaxaplin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 35 sitesUnited States
- Study dates
- 4 Feb 2025to 20 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has an APOL1 genotype of G1/G1, G2/G2, or G1/G2 obtained with a Vertex designated investigational clinical study assay
- Estimated Glomerular Filtration Rate (eGFR) of greater than or equal to (≥) 25 milliliter per minute (mL/min)/1.73m^2 at screening
Who cannot join
- Evidence of Focal Segmental Glomerulosclerosis (FSGS) with a known cause other than due to APOL1 risk variants
- Uncontrolled hypertension
- Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808
North Carolina Nephrology P.A. - Cary Office
Cary, North Carolina, 27511
UNC Clinical and Translational Research Center
Chapel Hill, North Carolina, 27599-7155
Columbia Nephrology Associates, PA
Columbia, South Carolina, 29203
Renal Associates, LLC
Columbus, Georgia, 31904
Nephrology Associates, P.C.
Columbus, Mississippi, 39705
Dallas Renal Group - 2
Dallas, Texas, 75230
Dallas Renal Group - 1
Dallas, Texas, 75237
Dallas Nephrology Associates - Dallas Landry Office
Dallas, Texas, 75246
UTSW Medical Center - Nephrology
Dallas, Texas, 75390
Georgia Nephrology - Decatur
Decatur, Georgia, 30030
Duke University Hospital - Children's Health Center
Durham, North Carolina, 27710
Javara Inc./Privia Medical Group Georgia, LLC - Fayetteville
Fayetteville, Georgia, 30214
Foundation for Sickle Cell Disease Research, LLC
Hollywood, Florida, 33023
Prolato Clinical Research Center
Houston, Texas, 77054
Nephrology Consultants, LLC
Huntsville, Alabama, 35805
DaVita Kidney Care - Las Vegas
Las Vegas, Nevada, 89107
South Florida Research Institute
Lauderdale Lakes, Florida, 33313
Scott Research, Inc.
Laurelton, New York, 11413
Georgia Nephrology
Lawrenceville, Georgia, 30046
LCMC Health
Metairie, Louisiana, 70006
Schiff Center for Liver Diseases
Miami, Florida, 33136
Eastern Nephrology Associates - New Bern Office
New Bern, North Carolina, 28562
Ochsner Medical Center - New Orleans - Nephrology
New Orleans, Louisiana, 70121
NYC Health + Hospital/Harlem
New York, New York, 10037
Saint Michael's Medical Center - Peter Ho Memorial Clinic
Newark, New Jersey, 07102
Rutgers Doctors Office Center
Newark, New Jersey, 07103
Tks Research, P.L.L.C.
Norfolk, Virginia, 23504
CTR Oakwater, LLC
Orlando, Florida, 32806
Lewis Katz School of Medicine at Temple University - Section of Nephrology
Philadelphia, Pennsylvania, 19140
Javara Inc. /Privia Medical Group Georgia, LLC - Savannah
Savannah, Georgia, 31406
Northwest Louisiana Nephrology, LLC - Shreveport
Shreveport, Louisiana, 71101
Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MD
Silver Spring, Maryland, 20901
Carolina Nephrology, PA
Spartanburg, South Carolina, 29306
Nephrology and Hypertension Associates, LTD
Tupelo, Mississippi, 38801
About this study
Official title: A Phase 2b, Open-label Study to Evaluate the Efficacy and Safety of Inaxaplin in Subjects With Proteinuric APOL1-mediated Kidney Disease With or Without Comorbidities That May Independently Contribute to Chronic Kidney Disease
The purpose of the study is to evaluate the efficacy, safety, and tolerability of Inaxaplin (IXP) in participants with proteinuric APOL1- mediated kidney disease (AMKD).
- Conditions
- Proteinuric Kidney Disease
- Being tested
- Inaxaplin
- Keywords
- APOL1-mediated kidney disease (AMKD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InaxaplinDrug
Also called IXP, VX-147
Tablets for Oral Administration.
| Study group | Role | What they receive |
|---|---|---|
| IXP (Inaxaplin) | Experimental | Participants with proteinuric APOL1-mediated kidney disease (AMKD) with or without the comorbidity of Type 2 diabetes mellitus (T2DM) will receive a single dose of IXP once daily, for 13 weeks. Receives: Drug: Inaxaplin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Urine Albumin-Creatinine Ratio (UACR)
Measured: Baseline and At Week 13
Secondary outcomes (1)
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Baseline Up To Week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start4 Feb 2025
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proteinuric Kidney DiseaseStudies 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
- 42 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
- NCT06794996
- Sponsor's protocol ID
- VX24-147-202
- Acronym
- AMPLIFIED
- Status last verified
- Aug 2026
- First submitted
- 23 Jan 2025
- Last updated
- 20 Aug 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/
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Open-label Study to Evaluate the Efficacy and Safety of Inaxaplin in Subjects With Proteinuric APOL1-mediated Kidney Disease With or Without Comorbidities That May Independently Contribute to Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06794996
- Acronym / sponsor ID
- AMPLIFIED / VX24-147-202
- Conditions
- Proteinuric Kidney Disease
- Keywords
- APOL1-mediated kidney disease (AMKD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 27 Jan 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 efficacy, safety, and tolerability of Inaxaplin (IXP) in participants with proteinuric APOL1- mediated kidney disease (AMKD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IXP (Inaxaplin) | Experimental | Drug: InaxaplinParticipants with proteinuric APOL1-mediated kidney disease (AMKD) with or without the comorbidity of Type 2 diabetes mellitus (T2DM) will receive a single dose of IXP once daily, for 13 weeks. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant has an APOL1 genotype of G1/G1, G2/G2, or G1/G2 obtained with a Vertex designated investigational clinical study assay
- Estimated Glomerular Filtration Rate (eGFR) of greater than or equal to (≥) 25 milliliter per minute (mL/min)/1.73m^2 at screening
Key exclusion criteria (3 listed)
- Evidence of Focal Segmental Glomerulosclerosis (FSGS) with a known cause other than due to APOL1 risk variants
- Uncontrolled hypertension
- Other protocol defined Inclusion/Exclusion criteria may 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 |
|---|---|---|
| InaxaplinAlso: IXP, VX-147Tablets for Oral Administration. | Drug | IXP (Inaxaplin) |
Primary outcome
Percent Change in Urine Albumin-Creatinine Ratio (UACR)
Time frame: Baseline and At Week 13
1 secondary outcome
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Baseline Up To Week 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- 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.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inaxaplin in people with Proteinuric Kidney Disease, run by Vertex Pharmaceuticals Incorporated at 35 sites in United States.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent Change in Urine Albumin-Creatinine Ratio (UACR) (time frame: Baseline and At Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.