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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05125068




Registration number
NCT05125068
Ethics application status
Date submitted
8/11/2021
Date registered
18/11/2021
Date last updated
26/03/2024

Titles & IDs
Public title
Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)
Scientific title
A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy
Secondary ID [1] 0 0
2021-004795-34
Secondary ID [2] 0 0
AT-1501-N205
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
IgA Nephropathy 0 0
IgAN 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AT-1501

Experimental: Arm A - 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.

Experimental: Arm B - 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


Treatment: Drugs: AT-1501
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy - change in participants UPCR
Timepoint [1] 0 0
Up to 24 weeks
Primary outcome [2] 0 0
Safety- Number of participants with treatment related adverse events
Timepoint [2] 0 0
Through study completion, an average of 100 weeks
Secondary outcome [1] 0 0
Change in eGFR slope
Timepoint [1] 0 0
Baseline- 96 weeks
Secondary outcome [2] 0 0
Change in urine protein excretion (mg/mg)
Timepoint [2] 0 0
Up to 96 weeks
Secondary outcome [3] 0 0
Development of Anti drug Antibodies (ADAs)
Timepoint [3] 0 0
Up to 96 weeks

Eligibility
Key inclusion criteria
1. Male or female = 18 years of age
2. Biopsy proven IgAN
3. Urine protein = 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB)
4. 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
5. Agree to comply with contraception requirements during and for 90 days after study completion.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any secondary IgAN as defined by the investigator
2. Patients who have undergone a kidney transplant
3. Any history of kidney disease other than IgAN
4. Any history of diabetes (Type 1 or Type 2)
5. 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
6. Pregnancy or breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2023
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
South WalesVIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Western Health - St Albans
Recruitment postcode(s) [1] 0 0
NSW 2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
- St Albans
Recruitment outside Australia
Country [1] 0 0
Croatia
State/province [1] 0 0
Zagreb
Country [2] 0 0
Malaysia
State/province [2] 0 0
Kuala Lumpur WP
Country [3] 0 0
Malaysia
State/province [3] 0 0
Pahang
Country [4] 0 0
Malaysia
State/province [4] 0 0
Sabah
Country [5] 0 0
Malaysia
State/province [5] 0 0
Selangor
Country [6] 0 0
New Zealand
State/province [6] 0 0
Hamilton
Country [7] 0 0
New Zealand
State/province [7] 0 0
Hastings
Country [8] 0 0
Philippines
State/province [8] 0 0
Manila
Country [9] 0 0
Poland
State/province [9] 0 0
Bialystok
Country [10] 0 0
Poland
State/province [10] 0 0
Krakow
Country [11] 0 0
Spain
State/province [11] 0 0
Valencia
Country [12] 0 0
Spain
State/province [12] 0 0
Madrid
Country [13] 0 0
Spain
State/province [13] 0 0
Sevilla
Country [14] 0 0
Spain
State/province [14] 0 0
Zaragoza
Country [15] 0 0
Sri Lanka
State/province [15] 0 0
Colombo
Country [16] 0 0
Sri Lanka
State/province [16] 0 0
Nugegoda
Country [17] 0 0
Thailand
State/province [17] 0 0
Bangkok
Country [18] 0 0
Thailand
State/province [18] 0 0
Chiang Mai
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Camberwell

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eledon Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT05125068
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05125068