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Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy
The ASSIST study is a phase 2, double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of atrasentan vs. placebo in subjects with IgA nephropathy (IgAN) while on background standard of care therapy and an SGLT2 inhibitor (SGLT2i).
Study details:
Approximately 52 patients with biopsy-proven IgAN who are on a background SGLT2i and a maximally tolerated and stable dose of a renin-angiotensin system inhibitor (RASi) \[such as angiotensin converting enzyme inhibitor (ACEi) or angiotensin-receptor antagonist (ARB)\] as part of standard of care, will be randomized to either sequence AB or sequence BA in which they will receive 0. 75 mg atrasentan once daily during one period (period A), complete a 12-week washout period, and then receive matching placebo during the other period (period B) as determined by the randomization schema. Subjects who are not on background SGLT2i therapy must be willing to undergo a run-in period of 8 weeks with an SGLT2i with a 24-hour total urine protein of \> 0.
85 grams/day at screening prior to the run-in period and have 24-hour total urine protein of \> 0. 5 grams/day at the end of the run-in period to be eligible for randomization. Subjects will remain on their maximally tolerated and stable dose of RASi and stable dose of SGLT2i therapies for the duration of the study following randomization.
The primary objective of the study is to evaluate the efficacy of atrasentan vs. placebo while on background therapy with SGLT2i. Subjects will have safety and efficacy assessments for 1 year (52 weeks).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-07-20
Primary completion: 2025-10-22
Study completion finish: 2026-08-19
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05834738
Intervention or treatment
DRUG: Atrasentan
DRUG: Atrasentan
DRUG: Placebo
Conditions
- • Immunoglobulin A Nephropathy
- • IgA Nephropathy
Find a site
Closest Location:
Prince of Wales Hospital
Research sites nearby
Select from list below to view details:
Prince of Wales Hospital
Sydney, New South Wales, Australia
Sunshine Hospital
St Albans, Victoria, Australia
The St. George Hospital
Kogarah, New South Wales, Australia
Monash Health- Monash Medical Centre
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Sequence AB
| DRUG: Atrasentan
|
EXPERIMENTAL: Sequence BA
| DRUG: Atrasentan
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Change From Baseline in Proteinuria at Week 12 in Both Treatment Periods 1 and 2 | The change in urine protein: creatinine ratio (UPCR) from baseline to Week 12 | Baseline and 12 weeks or approximately 3 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Change From Baseline in Proteinuria at Week 24 in Treatment Periods 2 | The change in UPCR from baseline to Week 24 | Baseline and 24 weeks or approximately 6 months |
Number of Subjects With Adverse Events (AEs) | Type, incidence, severity, seriousness, and relatedness of AEs will be collected. | From informed consent until end of study, approximately 60 weeks |
Plasma Concentration of Atrasentan | Blood samples will be collected for the measurement of plasma concentrations of atrasentan. | Treatment Period 1: Pre-dose on Weeks 2, 6 and 12; Treatment Period 2: Pre-dose on Weeks 2, 6, 12 and 24 |
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