Nephrotic SyndromePhase 2NCT05599815
Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
A Phase 2 study testing ADX-629 in people with Nephrotic Syndrome, run by Aldeyra Therapeutics, Inc. at 11 sites in United States.
Trial summary
A Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- ADX-629
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 11 sitesUnited States
- Study dates
- Jan 2023to May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age
- History of nephrotic syndrome, characterized by heavy proteinuria and hypoalbuminemia
- Recent nephrotic relapse in the 6 months prior to screening
- Estimated glomerular filtration rate (eGFR) of ≥45 during screening
- Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable
Who cannot join
- Subjects with collapsing FSGS focal segmental glomerulosclerosis (FSGS)
- Known secondary cause of nephrotic syndrome (e.g., diabetic nephropathy, systemic lupus erythematous, sickle cell anemia, malignancy, drug-induced, malaria)
- History of kidney transplantation or other solid organ transplantation
- History of any unstable chronic diseases/conditions, clinically significant abnormalities, or findings, that in the opinion of the Investigator, could compromise subject safety or affect the conduct of the trial
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Emory University - Pediatric Nephrology
Atlanta, Georgia, 30322
University of Colorado
Aurora, Colorado, 80045
ClinCept, LLC
Bremen, Georgia, 30110
The Ohio State University (OSU) Wexner Medical Center
Columbus, Ohio, 43004
East Carolina University - Nephrology
Greenville, North Carolina, 27834
Nevada Kidney Disease Hypertension Center (NKDHC)
Las Vegas, Nevada, 88901
South Florida Research Institute
Lauderdale Lakes, Florida, 33309
Amicis Research Center - Northridge
Northridge, California, 91324
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101
Southern Utah Kidney and Hypertension Center
St. George, Utah, 84765
University of Toledo Medical Center
Toledo, Ohio, 43537
About this study
Official title: A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
A Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
Read the detailed description
ADX-629-MCD-001 is a multi-center, two-part, Phase 2 clinical trial designed to evaluate the safety and efficacy of ADX-629 in Subjects with frequently relapsing and steroid-dependent nephrotic syndrome. Study drug will be administered orally every 12 hours (twice daily) to eligible subjects for 90 days. The study will enroll approximately 35 children and adults with nephrotic syndrome who have had a nephrotic relapse in the 6 months prior to screening.
The clinical trial is divided into 2 parts: Part 1 (open-label) and Part 2 (double-blinded, randomized).
Part 1: Approximately 5 eligible subjects will receive open-label ADX-629 (250 mg) twice daily for 90 days.
Part 2: Approximately 30 eligible subjects will be randomized in a 2:1 ratio to receive either ADX-629 (250 mg) or matching placebo twice daily for 90 days.
Patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.
- Conditions
- Nephrotic Syndrome
- Being tested
- ADX-629
- Keywords
- Idiopathic nephrotic syndrome, Focal segmental glomerulosclerosis (FSGS), Minimal change disease, Frequently relapsing nephrotic syndrome, ADX-629, Reactive aldehyde species (RASP), Chronic kidney disease
- Medical subject headings
- Nephrotic Syndrome, Nephrosis, Lipoid, Glomerulosclerosis, Focal Segmental, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-629Drug
ADX-629 (250 milligrams) administered twice daily
| Study group | Role | What they receive |
|---|---|---|
| ADX-629 | Experimental | Not described Receives: Drug: ADX-629 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AE) Query
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: From Day 1 to Day 90
Secondary outcomes (1)
Relapse Frequency
Proportion of subjects with one or more relapse(s), as defined by treatment with corticosteroid therapy
Measured: From Day 1 to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study startJan 2023 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: Lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599815
- Sponsor's protocol ID
- ADX-629-MCD-001
- Status last verified
- Apr 2024
- First submitted
- 26 Oct 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.
PubMed 39513526Meliambro K, He JC, Campbell KN. Podocyte-targeted therapies - progress and future directions. Nat Rev Nephrol. 2024 Oct;20(10):643-658. doi: 10.1038/s41581-024-00843-z. Epub 2024 May 9.
PubMed 38724717
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT05599815
- Acronym / sponsor ID
- ADX-629-MCD-001
- Conditions
- Nephrotic Syndrome
- Keywords
- Idiopathic nephrotic syndrome, Focal segmental glomerulosclerosis (FSGS), Minimal change disease, Frequently relapsing nephrotic syndrome, ADX-629, Reactive aldehyde species (RASP), Chronic kidney disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2023 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 31 Oct 2022 (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.
A Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
Detailed description
ADX-629-MCD-001 is a multi-center, two-part, Phase 2 clinical trial designed to evaluate the safety and efficacy of ADX-629 in Subjects with frequently relapsing and steroid-dependent nephrotic syndrome. Study drug will be administered orally every 12 hours (twice daily) to eligible subjects for 90 days. The study will enroll approximately 35 children and adults with nephrotic syndrome who have had a nephrotic relapse in the 6 months prior to screening.
The clinical trial is divided into 2 parts: Part 1 (open-label) and Part 2 (double-blinded, randomized).
Part 1: Approximately 5 eligible subjects will receive open-label ADX-629 (250 mg) twice daily for 90 days.
Part 2: Approximately 30 eligible subjects will be randomized in a 2:1 ratio to receive either ADX-629 (250 mg) or matching placebo twice daily for 90 days.
Patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADX-629 | Experimental | Drug: ADX-629 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥18 years of age
- History of nephrotic syndrome, characterized by heavy proteinuria and hypoalbuminemia
- Recent nephrotic relapse in the 6 months prior to screening
- Estimated glomerular filtration rate (eGFR) of ≥45 during screening
- Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable
Key exclusion criteria (4 listed)
- Subjects with collapsing FSGS focal segmental glomerulosclerosis (FSGS)
- Known secondary cause of nephrotic syndrome (e.g., diabetic nephropathy, systemic lupus erythematous, sickle cell anemia, malignancy, drug-induced, malaria)
- History of kidney transplantation or other solid organ transplantation
- History of any unstable chronic diseases/conditions, clinically significant abnormalities, or findings, that in the opinion of the Investigator, could compromise subject safety or affect the conduct of the trial
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 |
|---|---|---|
| ADX-629ADX-629 (250 milligrams) administered twice daily | Drug | ADX-629 |
Primary outcome
Adverse Event (AE) Query
Time frame: From Day 1 to Day 90
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
1 secondary outcome
Relapse Frequency
Time frame: From Day 1 to Day 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 39513526Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.
- Derived from this study: PubMed 38724717Meliambro K, He JC, Campbell KN. Podocyte-targeted therapies - progress and future directions. Nat Rev Nephrol. 2024 Oct;20(10):643-658. doi: 10.1038/s41581-024-00843-z. Epub 2024 May 9.
- Individual participant dataSharing planned: No
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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.
11 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 ADX-629 in people with Nephrotic Syndrome, run by Aldeyra Therapeutics, Inc. at 11 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 5 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: withdrawn, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 was withdrawn before enrolling participants, so there are no results.
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?
Adverse Event (AE) Query (time frame: From Day 1 to Day 90). 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 NCT05599815, which also lists 2 linked publications.
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 17 Apr 2024.