Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy
ASSIST
A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy on Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i)
2 other identifiers
interventional
54
6 countries
30
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2023
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2023
CompletedFirst Posted
Study publicly available on registry
April 28, 2023
CompletedStudy Start
First participant enrolled
July 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2025
CompletedJanuary 30, 2026
January 1, 2026
1.9 years
April 18, 2023
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change From Baseline in Proteinuria at Week 24 in Treatment Periods 2
Baseline and 24 weeks or approximately 6 months
Number of Subjects With Adverse Events (AEs)
From informed consent until end of study, approximately 60 weeks
Plasma Concentration 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
Study Arms (2)
Sequence AB
EXPERIMENTALOnce 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)
Sequence BA
EXPERIMENTALOnce 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)
Interventions
Period A (12 Weeks) - Film-coated tablet, Washout Period: 12 weeks, Period B (24 Weeks) - Placebo
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- 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)
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) - Nephrology Clinic
Birmingham, Alabama, 35233, United States
Fides Clinical Research
Atlanta, Georgia, 30342, United States
NANI Research
Oak Brook, Illinois, 60523, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of North Carolina at Chapel Hill - Nephrology and Hypertension
Chapel Hill, North Carolina, 27599, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The St. George Hospital
Kogarah, New South Wales, 2217, Australia
Prince of Wales Hospital
Sydney, New South Wales, 2031, Australia
Monash Health- Monash Medical Centre
Melbourne, Victoria, 3168, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
NUPEC Cardio
Belo Horizonte, Minas Gerais, 30220-140, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
Universidade Federal de Sao Paulo
São Paulo, São Paulo, 04038-002, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-000, Brazil
Hopsital Sultanah Aminah Johor Bharu (HSAJB) - Bangunan Bakawali Heodialysis Centre
Johor Bahru, Johor Darul Takzim, 80100, Malaysia
Universiti Kebangsaan Malaysia (UKM) - Medical Centre (Pusat Perubatan) (Hospital Canselor Tuanku Muhriz (HCTM))
Cheras, Kuala Lumpur, 56000, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Hospital Raja Permaisuri Bainun (HRPB)
Ipoh, Perak, 30450, Malaysia
Dong-A University Medical Center (Dong-A University Hospital)
Busan, Busan, 49201, South Korea
Soon Chun Hyang Central Medical Center (SCHMC) - Soon Chun Hyang University Hospital
Cheonan, Chungnam-Do, 31151, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068, South Korea
Chung-Ang University College
Seoul, Seoul, 06973, South Korea
Hospital Torrecardenas
Almería, 04009, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital del Vall d´Hebron
Barcelona, 08035, Spain
Hospital Ribera Polusa
Lugo, 27004, Spain
Hospital Universitario De Getafe (HUG)
Madrid, 28009, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Virgen Macarena
Seville, 41009, Spain
Hospital Clinico Universitario
Valencia, 46010, Spain
Related Publications (2)
Heerspink HJL, Noronha IL, Gorriz JL, Lim SK, Kotwal SS, Kirsztajn GM, Barros Neto J, Ryan J, Fu MS, Kim SG, Barratt J, Brahmbhatt Y, Housler GJ, Jiao R, Dahlke M, Lodha A, Mottl AK; Atrasentan and Sodium Glucose Co-transporter-2 Inhibitor Efficacy and Safety Trial (Assist) Investigator Group. Efficacy and Safety of Atrasentan in Patients with IgA Nephropathy Receiving Sodium-Glucose Cotransporter 2 Inhibitors: Placebo-Controlled, Crossover Trial. J Am Soc Nephrol. 2026 Mar 29. doi: 10.1681/ASN.0000001076. Online ahead of print.
PMID: 41904616DERIVEDTunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
PMID: 38299639DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2023
First Posted
April 28, 2023
Study Start
July 20, 2023
Primary Completion
June 30, 2025
Study Completion
October 29, 2025
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.