IgA NephropathyPhase 2NCT05125068
Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)
A Phase 2 study testing AT-1501 in people with IgA Nephropathy and IgAN, run by Eledon Pharmaceuticals at 26 sites in 10 countries.
Trial summary
This is a phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- IgA Nephropathy, IgAN
- What is being tested?
- AT-1501
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 26 sitesin 10 countries
- Study dates
- 21 Mar 2022to 31 Jul 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age
- Biopsy proven IgAN
- Urine protein ≥ 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB)
- eGFR ≥ 45 mL/min per 1.73 m2 or eGFR < 45 mL/min per 1.73 m2 and ≥ 30 mL/min per 1.73 m2 with a kidney biopsy within 2 years of Screening showing < 50% tubulointerstitial fibrosis
- Agree to comply with contraception requirements during and for 90 days after study completion.
Who cannot join
- Any secondary IgAN as defined by the investigator
- Patients who have undergone a kidney transplant
- Any history of kidney disease other than IgAN
- Any history of diabetes (Type 1 or Type 2)
- Seated blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at the Screening Visit. Patients must be on a stable dose and regimen of an ACE inhibitor or ARB for at least 90 days
- Pregnancy or breastfeeding.
Trial locations and contacts
26 sites in 10 countries.
26 sites in 10 countries
Malaysia5 sites
Hospital Kajang
Kajang, Selangor, 43000
Hospital Serdang
Kajang, Selangor, 43000
Hospital Queen Elizabeth
Kota Kinabalu, Sabah
University Malaya Medical Centre (UMMC)
Kuala Lumpur, Kuala Lumpur WP, 59100
Hospital Tengku Ampuan Afzan (HTAA)
Kuantan, Pahang, 25100
Spain4 sites
Hospital Clinico San Carlos
Madrid
Hospital de Sagunto
Sagunto, Valencia
Hospital Virgen de la Macarena
Seville
Hospital Universitario Miguel Servet
Zaragoza
Thailand4 sites
Phramongkutklao Hospital
Bangkok
Chiang Mai University
Chiang Mai
Prince of Songkla University
Dusit, Bangkok
Chulalongkorn University
Pathum Wan, Bangkok, 10330
Australia3 sites
Monash Medical Centre
Clayton, Victoria, 3168
Liverpool Hospital
Liverpool, South Wales, NSW 2170
Western Health
St Albans, Victoria
Croatia2 sites
University Hospital Centre Sisters of Charity
Zagreb
University Hospital Dubrava Zagreb
Zagreb
New Zealand2 sites
Waikato Hospital
Hamilton, 3204
Hawke's Bay Hospital
Hastings, 4120
Poland2 sites
Medical University of Bialystok UI
Bialystok
Specjalistyczne Centrum Medyczne, SCM Spółka
Krakow
Sri Lanka2 sites
National Hospital of Sri Lanka
Colombo, 01000
Sri Jayawardanepura General Hospital
Nugegoda, 10250
About this study
Official title: A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy
This is a phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening.
Read the detailed description
Phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of Screening. Up to 42 eligible patients will receive one of 2 doses of AT-1501. All patients are scheduled to receive AT-1501 by intravenous infusion every 3 weeks for approximately 2 years.
- Conditions
- IgA Nephropathy, IgAN
- Being tested
- AT-1501
- Keywords
- IgA Nephropathy, IgAN, AT-1501, CD40L, Monoclonal antibody, Proteinuria, eGFR, UPCR
- Medical subject headings
- Glomerulonephritis, IGA, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-1501Drug
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | AT-1501 10mg/kg Arm A will receive 10 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions. Receives: Drug: AT-1501 |
| Arm B | Experimental | AT-1501 5mg/kg Arm B will receive 5 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions Receives: Drug: AT-1501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - change in participants UPCR
The change in 24-hour urine protein to creatinine ratio (UPCR) from baseline to 24 weeks
Measured: Up to 24 weeks
Safety- Number of participants with treatment related adverse events
Incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs of special interest (AEoSI)
Measured: Through study completion, an average of 100 weeks
Secondary outcomes (3)
Change in eGFR slope
The change in eGFR slope from baseline to 96 weeks
Measured: Baseline- 96 weeks
Change in urine protein excretion (mg/mg)
The change in urine protein excretion over time
Measured: Up to 96 weeks
Development of Anti drug Antibodies (ADAs)
The percentage of participants who develop ADAs
Measured: Up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start21 Mar 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Why it stopped: An administrative decision was made to terminate the AT-1501-N205 study. This voluntary business-related decision was not related to the safety of tegoprubart (AT-1501). Available safety data demonstrated tegoprubart to be safe and well tolerated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eledon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125068
- Sponsor's protocol ID
- AT-1501-N205
- Other IDs
- 2021-004795-34, U1111-1269-7356
- Status last verified
- Mar 2024
- First submitted
- 8 Nov 2021
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy
- ClinicalTrials.gov ID
- NCT05125068
- Acronym / sponsor ID
- AT-1501-N205
- Conditions
- IgA Nephropathy, IgAN
- Keywords
- IgA Nephropathy, IgAN, AT-1501, CD40L, Monoclonal antibody, Proteinuria, eGFR, UPCR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An administrative decision was made to terminate the AT-1501-N205 study. This voluntary business-related decision was not related to the safety of tegoprubart (AT-1501). Available safety data demonstrated tegoprubart to be safe and well tolerated.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eledon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 18 Nov 2021 (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.
This is a phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening.
Detailed description
Phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of Screening. Up to 42 eligible patients will receive one of 2 doses of AT-1501. All patients are scheduled to receive AT-1501 by intravenous infusion every 3 weeks for approximately 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: AT-1501AT-1501 10mg/kg Arm A will receive 10 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions. |
| Arm B | Experimental | Drug: AT-1501AT-1501 5mg/kg Arm B will receive 5 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥ 18 years of age
- Biopsy proven IgAN
- Urine protein ≥ 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB)
- eGFR ≥ 45 mL/min per 1.73 m2 or eGFR < 45 mL/min per 1.73 m2 and ≥ 30 mL/min per 1.73 m2 with a kidney biopsy within 2 years of Screening showing < 50% tubulointerstitial fibrosis
- Agree to comply with contraception requirements during and for 90 days after study completion.
Key exclusion criteria (6 listed)
- Any secondary IgAN as defined by the investigator
- Patients who have undergone a kidney transplant
- Any history of kidney disease other than IgAN
- Any history of diabetes (Type 1 or Type 2)
- Seated blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at the Screening Visit. Patients must be on a stable dose and regimen of an ACE inhibitor or ARB for at least 90 days
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 |
|---|---|---|
| AT-1501AT-1501 monoclonal antibody targeting CD40L given as an IV infusion | Drug | Arm A, Arm B |
Primary outcome
Efficacy - change in participants UPCR
Time frame: Up to 24 weeks
The change in 24-hour urine protein to creatinine ratio (UPCR) from baseline to 24 weeks
Safety- Number of participants with treatment related adverse events
Time frame: Through study completion, an average of 100 weeks
Incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs of special interest (AEoSI)
3 secondary outcomes
Change in eGFR slope
Time frame: Baseline- 96 weeks
Change in urine protein excretion (mg/mg)
Time frame: Up to 96 weeks
Development of Anti drug Antibodies (ADAs)
Time frame: Up to 96 weeks
Results and safety
The study was stopped early (reason given: An administrative decision was made to terminate the AT-1501-N205 study. This voluntary business-related decision was not related to the safety of tegoprubart (AT-1501). Available safety data demonstrated tegoprubart to be safe and well tolerated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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.
26 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AT-1501 in people with IgA Nephropathy and IgAN, run by Eledon Pharmaceuticals at 26 sites in 10 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Malaysia, Spain, Thailand, Australia, Croatia and 5 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?
The study was stopped early (reason given: An administrative decision was made to terminate the AT-1501-N205 study. This voluntary business-related decision was not related to the safety of tegoprubart (AT-1501). Available safety data demonstrated tegoprubart to be safe and well tolerated.). Results are not available in the source record.
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?
Efficacy - change in participants UPCR (time frame: Up to 24 weeks). The study lists 2 primary outcomes in all. 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 26 Mar 2024.