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Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy

PHASE2RECRUITING

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).

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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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Legal adults (per local and country specifications) ≥ 18 years of age at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.

Biopsy-proven IgA nephropathy.

Receiving a maximally tolerated and stable dose of a RASi for at least 12 weeks prior to screening. Investigator discretion should be used in determining maximally tolerated and optimized dose.

eGFR of at least 30 mL/min/1.73 m^2 at screening based on the 2021 CKD-EPI equation.

Willing to agree to highly effective forms of contraception, as specified in the protocol, throughout the study and for up to 1 month afterward. In WOCBP, use of hormonal contraceptive agents must have been started at least 1 month prior to baseline.

Willing and able to provide informed consent and comply with all study requirements.

Inclusion Criteria for SGLT2i stable subjects

Receiving a stable dose of an SGLT2i for at least 8 weeks prior to screening

Must have a 24-hour urine protein of >0.5 grams/day.

Inclusion Criteria for Run-In Subjects

Must have a 24-hour total urine protein of >0.85 grams/day at screening

Willing to participate in an 8-week run-in period with an SGLT2i (per Investigator choice)

Additional Inclusion Criteria for Run-in Subjects at the end of Run-In

Must have completed the 8-week run-in period on a stable and well tolerated dose of an SGLT2i

Must have a 24-hour total urine protein of >0.5 grams/day confirmed at the Run-in Week 8 visit.

Must have an eGFR of ≥ 30 mL/min/1.73 m^2 based on the CKD-EPI equation at their Run-in Week 8 visit.

Exclusion criteria

Current diagnosis with another chronic kidney disease, including diabetic kidney disease.

History of kidney transplantation or other organ transplantation.

Use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months.

Blood pressure above 150 mmHg systolic or 95 mmHg diastolic as evaluated by the Investigator.

Known history of heart failure or prior hospital admissions for conditions relating to fluid overload that in the opinion of the Principal Investigator or Sponsor might confound the results of the study or pose additional risk to the participant by their participation in the study.

Clinically significant history of liver disease as assessed by the Investigator.

Hemoglobin below 9 g/dL as measured by the Investigator or prior history of blood transfusion for anemia within the past 3 months.

Malignancy within the past 5 years. Exceptions to this criteria include nonmelanoma skin cancer and curatively treated cervical carcinoma in situ.

For women, pregnancy, breast feeding, or intent to become pregnant during the study. and at least 1 month afterward.

For men, intent to father a child or donate sperm during the study.

Have received any investigational agent or approved treatment for IgAN (other than a RAS inhibitor) including SGLT2i (except for subjects in the SGLT2i stable stratum) within 1 month (or 5 half-lives of the agent, whichever is longer) prior to Screening. If the investigational agent is a cytotoxic or immunosuppressive agent then this washout period is 6 months.

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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: Placebo

Conditions

• Immunoglobulin A Nephropathy
• IgA Nephropathy

Image related to Immunoglobulin A Nephropathy

Condition: Immunoglobulin A Nephropathy, IgA Nephropathy
DRUG: Atrasentan and other drugs
Sydney, New South Wales, Australia and more
Sponsor: Chinook Therapeutics, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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 Once daily oral administration of 0.75 mg atrasentan for 12 weeks (Period A) followed by once daily oral administration of placebo for 24 weeks (Period B)	DRUG: Atrasentan Period A (12 Weeks) - Film-coated tablet, Washout Period: 12 weeks, Period B (24 Weeks) - Placebo
EXPERIMENTAL: Sequence BA Once daily oral administration of placebo for 12 weeks (Period B) followed by once daily oral administration of 0.75 mg atrasentan for 24 weeks (Period A)	DRUG: Atrasentan Period B (12 Weeks) - Placebo, Washout Period: 12 weeks, Period A (24 Weeks) - Film-coated tablet

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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy