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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05834738




Registration number
NCT05834738
Ethics application status
Date submitted
18/04/2023
Date registered
28/04/2023
Date last updated
22/05/2024

Titles & IDs
Public title
Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy
Scientific title
A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy on Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i)
Secondary ID [1] 0 0
CHK01-03
Universal Trial Number (UTN)
Trial acronym
ASSIST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
IgA Nephropathy 0 0
Immunoglobulin A Nephropathy 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 - Atrasentan
Treatment: Drugs - Atrasentan
Treatment: Drugs - Placebo

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)

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)


Treatment: Drugs: Atrasentan
Period A (12 Weeks) - Film-coated tablet, Washout Period: 12 weeks, Period B (24 Weeks) - Placebo

Treatment: Drugs: Atrasentan
Period B (12 Weeks) - Placebo, Washout Period: 12 weeks, Period A (24 Weeks) - Film-coated tablet

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Proteinuria at Week 12 in Both Treatment Periods 1 and 2
Timepoint [1] 0 0
Baseline and 12 weeks or approximately 3 months
Secondary outcome [1] 0 0
Change From Baseline in Proteinuria at Week 24 in Treatment Periods 2
Timepoint [1] 0 0
Baseline and 24 weeks or approximately 6 months
Secondary outcome [2] 0 0
Number of Subjects With Adverse Events (AEs)
Timepoint [2] 0 0
From informed consent until end of study, approximately 60 weeks
Secondary outcome [3] 0 0
Plasma Concentration of Atrasentan
Timepoint [3] 0 0
Treatment Period 1: Pre-dose on Weeks 2, 6 and 12; Treatment Period 2: Pre-dose on Weeks 2, 6, 12 and 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/08/2026
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
The St. George Hospital - Kogarah
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [3] 0 0
Monash Health- Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2031 - Sydney
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
Brazil
State/province [5] 0 0
Minas Gerais
Country [6] 0 0
Brazil
State/province [6] 0 0
Rio Grande Do Sul
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Paulo
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Chungnam-Do
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Gyeonggi-do
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Busan
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Malaysia
State/province [12] 0 0
Kuala Lumpur
Country [13] 0 0
Malaysia
State/province [13] 0 0
Perak
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Spain
State/province [15] 0 0
Galicia
Country [16] 0 0
Spain
State/province [16] 0 0
Valencia
Country [17] 0 0
Spain
State/province [17] 0 0
Almería
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Spain
State/province [19] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Chinook Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05834738
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05834738