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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/NCT04573478




Registration number
NCT04573478
Ethics application status
Date submitted
12/09/2020
Date registered
5/10/2020
Date last updated
23/05/2024

Titles & IDs
Public title
Atrasentan in Patients With IgA Nephropathy
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function
Secondary ID [1] 0 0
CHK01-01
Universal Trial Number (UTN)
Trial acronym
ALIGN
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 - Placebo

Experimental: Atrasentan - Double-blind Period: Once daily oral administration of 0.75 mg atrasentan for 132 weeks.
Open-label Extension Period: Once daily oral administration of 0.75 mg atrasentan for 48 weeks after completion of 132 weeks on atrasentan or placebo.

Placebo Comparator: Placebo - Double-blind Period: Once daily oral administration of placebo for 132 weeks


Treatment: Drugs: Atrasentan
Film-coated tablet

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

Outcomes
Primary outcome [1] 0 0
Double-blind period: Change in proteinuria
Timepoint [1] 0 0
Up to Week 36 or approximately 9 months
Primary outcome [2] 0 0
Open-label period: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
From open-label baseline up to end of treatment visit, 48 weeks
Primary outcome [3] 0 0
Open-label period: Number of Subjects With Adverse Events of Special Interest (AESI) Including Events of Fluid Overload
Timepoint [3] 0 0
From open-label baseline up to end of treatment visit, 48 weeks
Secondary outcome [1] 0 0
Double-blind period: Change in eGFR
Timepoint [1] 0 0
Up to Week 136, 4 weeks post end of treatment
Secondary outcome [2] 0 0
Double-blind period: Percent of subjects meeting the first composite endpoint
Timepoint [2] 0 0
Up to approximately 2.6 years
Secondary outcome [3] 0 0
Double-blind period: Percent of subjects meeting the second composite endpoint
Timepoint [3] 0 0
Up to approximately 2.6 years
Secondary outcome [4] 0 0
Double-blind period: Percent of subjects achieving reduction of proteinuria to < 1 g/day at Week 36
Timepoint [4] 0 0
Baseline to Week 36
Secondary outcome [5] 0 0
Double-blind period: Number of Subjects With TEAEs
Timepoint [5] 0 0
From first dose of study drug up to 4 weeks post end of treatment in double-blind period, 136 weeks
Secondary outcome [6] 0 0
Double-blind period: Number of Subjects With AESI Including Events of Fluid Overload
Timepoint [6] 0 0
From first dose of study drug up to 4 weeks post end of treatment in double-blind period, 136 weeks
Secondary outcome [7] 0 0
Open-label period: Change in proteinuria
Timepoint [7] 0 0
Open-label Baseline to open-label Week 36
Secondary outcome [8] 0 0
Open-label period: Change in eGFR
Timepoint [8] 0 0
Open-label Baseline to open-label Week 52

Eligibility
Key inclusion criteria
Double-Blind period:

- Biopsy-proven IgA nephropathy.

- Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has
been stable for at least 12 weeks. Exceptions from this requirement will be made for
subjects who are unable to tolerate RAS inhibitor therapy.

- Total urine protein =1 g/day as measured via 24-hour urine collection by central
laboratory at Screening.

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

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

- SGLT2i Stable Stratum Only - Receiving a stable dose of an SGLT2i (per Investigator
choice) in addition to a maximally tolerated and optimized dose of a RAS inhibitor
that has been stable for at least 12 weeks prior to Screening.

- All fertile men and WOCBP who engage in heterosexual intercourse must be willing to
abide with highly effective forms of contraception, as specified in the protocol,
throughout the study and for 1 month afterward. In WOCBP, use of contraceptive agents
must have been started at least 1 month prior to Baseline.

Open-Label Period:

- Willing and able to provide informed consent and comply with all OL extension study
visits and study procedures.

- Completed treatment through Week 132 and completed the Week 136 visit.

- All fertile men and WOCBP who engage in heterosexual intercourse must be willing to
abide with highly effective forms of contraception, as specified in the protocol,
throughout the study and for 1 month afterward. In WOCBP, use of contraceptive agents
must have been continued after completing the double-blind portion of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Double-blind period:

- Concurrent diagnosis of another cause of chronic kidney disease including diabetic
kidney disease or another primary glomerulopathy.

- Clinical diagnosis of nephrotic syndrome.

- BNP value of > 200 pg/mL at Screening.

- Platelet count <80,000 per µL at Screening.

- History of organ transplantation (subjects with history of corneal transplant are not
excluded).

- Use of systemic immunosuppressant medications.

- Hemoglobin below 9 g/dL at Screening or prior history of blood transfusion for anemia
within 3 months of Screening.

Open-label period:

- eGFR < 25 mL/min/1.73m^2 or evidence of rapidly decreasing eGFR, including unrecovered
acute kidney injury or expected to require renal replacement therapy within 3 months

- BNP value of > 200 pg/mL at OL Screening.

- Platelet count < 80,000 per µL at OL Screening.

- Hemoglobin below 9 g/dL at OL screening or prior history of blood transfusion for
anemia within 3 months of OL Screening.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
11/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/12/2026
Actual
Sample size
Target
380
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [2] 0 0
Melbourne Renal Research Group - Reservoir
Recruitment hospital [3] 0 0
Sunshine Hospital - Saint Albans
Recruitment hospital [4] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 0 0
Royal Brisbane & Women's Hospital - Brisbane
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
Renal Research - Gosford
Recruitment hospital [8] 0 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
3073 - Reservoir
Recruitment postcode(s) [3] 0 0
3021 - Saint Albans
Recruitment postcode(s) [4] 0 0
- Box Hill
Recruitment postcode(s) [5] 0 0
- Brisbane
Recruitment postcode(s) [6] 0 0
- Clayton
Recruitment postcode(s) [7] 0 0
- Gosford
Recruitment postcode(s) [8] 0 0
- Kingswood
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Chinook Therapeutics U.S., Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy
and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of
progressive loss of renal function.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04573478
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/ct2/show/NCT04573478