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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04573920




Registration number
NCT04573920
Ethics application status
Date submitted
28/09/2020
Date registered
5/10/2020
Date last updated
10/10/2024

Titles & IDs
Public title
Atrasentan in Patients With Proteinuric Glomerular Diseases
Scientific title
A Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular Diseases
Secondary ID [1] 0 0
CHK01-02
Universal Trial Number (UTN)
Trial acronym
AFFINITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
IgA Nephropathy 0 0
Focal Segmental Glomerulosclerosis 0 0
Alport Syndrome 0 0
Diabetic Kidney Disease 0 0
Diabetic Nephropathy Type 2 0 0
Immunoglobulin A Nephropathy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

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

Experimental: Atrasentan 0.75 mg - Once daily oral administration of 0.75 mg atrasentan

Experimental: Atrasentan 1.5 mg - Once daily oral administration 1.5 mg atrasentan (FSGS cohorts only)


Treatment: Drugs: Atrasentan
Film-coated tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in proteinuria for IgAN, FSGS, and Alport syndrome patients receiving 0.75 mg atrasentan QD
Timepoint [1] 0 0
Up to Week 12 or approximately 3 months
Primary outcome [2] 0 0
Change in albuminuria for DKD patients
Timepoint [2] 0 0
Up to Week 12 or approximately 3 months
Primary outcome [3] 0 0
Change in proteinuria for FSGS patients at 1.5 mg dose
Timepoint [3] 0 0
Up to Week 24 or approximately 6 months
Primary outcome [4] 0 0
Change in proteinuria for FSGS patients at 1.5 mg dose
Timepoint [4] 0 0
Up to Week 30 or approximately 7.5 months

Eligibility
Key inclusion criteria
* Age 18 years and older for patients in the IgAN, FSGS, and Alport Syndrome cohorts
* Age 18-70 years for patients in the DKD cohort
* Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks.
* For patients enrolling in IgAN Cohort:

1. Biopsy-proven IgA nephropathy
2. UPCR between 0.5 to less than 1.0 g/g
3. Screening eGFR = 30 mL/min/1.73 m2
* For patients enrolling in FSGS Cohort:

1. Biopsy-proven FSGS or documented genetic mutation in a podocyte protein associated with FSGS
2. UPCR > 1.0 g/g
3. Screening eGFR = 30 mL/min/1.73 m2
4. Subjects receiving systemic corticosteroids or other immunosuppressants must be on a stable dose for at least 12 weeks.
5. BMI = 40 kg/m2
* For patients enrolling in Alport syndrome Cohort:

1. Diagnosis of Alport syndrome by genetic testing
2. UPCR > 0.5 g/g
3. Screening eGFR = 30 mL/min/1.73 m2
* For patients enrolling in DKD Cohort:

1. Diagnosis of type 2 diabetes mellitus
2. UACR = 0.5 g/g
3. Screening eGFR = 45 mL/min/1.73 m2
4. Receiving a stable dose of SGLT2 inhibitor for at least 12 weeks
* Willing and able to provide informed consent and comply with all study requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current diagnosis of another cause of chronic kidney disease or another primary glomerulopathy.
* History of kidney transplantation or other organ transplantation.
* Except for FSGS patients, 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.
* History of heart failure or a previous hospital admission for fluid overload.
* Clinically significant history of liver disease as assessed by the Investigator.
* Hemoglobin below 9 g/dL as measured by the Investigator or blood transfusion for anemia within the past 3 months.
* Clinical diagnosis of nephrotic syndrome
* Malignancy within the past 5 years. Exception to the criteria include nonmelanoma skin cancer and curatively treated cervical carcinoma in situ.
* For women, pregnant, breastfeeding, or intent to become pregnant during the study.
* For men, intent to father a child or donate sperm during the study.
* Recently received an investigational agent.
* Clinically significant unstable or uncontrolled medical condition as assessed by the Investigator.

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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/07/2026
Actual
Sample size
Target
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Renal Research - Gosford
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Monash Health- Monash Medical Centre - Clayton
Recruitment hospital [5] 0 0
Melbourne Renal Research Group - Reservoir
Recruitment hospital [6] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3073 - Reservoir
Recruitment postcode(s) [6] 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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Italy
State/province [13] 0 0
Lazio
Country [14] 0 0
Italy
State/province [14] 0 0
Lombardy
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Chungcheongnam-do
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Gangdong
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Gyeonggi-do
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Spain
State/province [19] 0 0
Galicia
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Spain
State/province [21] 0 0
Valencia
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
United Kingdom
State/province [23] 0 0
England
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Sheffield

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

Ethics approval
Ethics application status

Summary
Brief summary
The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function.
Trial website
https://clinicaltrials.gov/study/NCT04573920
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
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/NCT04573920