IgA NephropathyPhase 2ASSISTNCT05834738
Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy
A Phase 2 study testing Atrasentan in people with IgA Nephropathy and Immunoglobulin A Nephropathy, run by Novartis Pharmaceuticals at 30 sites in 6 countries.
Trial summary
The ASSIST study was 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy, Immunoglobulin A Nephropathy
- What is being tested?
- Atrasentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 30 sitesin 6 countries
- Study dates
- 20 Jul 2023to 29 Oct 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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)
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
30 sites in 6 countries.
30 sites in 6 countries
Spain8 sites
Hospital Torrecardenas
Almería, 04009
Hospital del Mar
Barcelona, 08003
Hospital del Vall d´Hebron
Barcelona, 08035
Hospital Ribera Polusa
Lugo, 27004
Hospital Universitario De Getafe (HUG)
Madrid, 28009
Hospital 12 de Octubre
Madrid, 28041
Hospital Virgen Macarena
Seville, 41009
Hospital Clinico Universitario
Valencia, 46010
United States6 sites
Fides Clinical Research
Atlanta, Georgia, 30342
University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) - Nephrology Clinic
Birmingham, Alabama, 35233
Tufts Medical Center
Boston, Massachusetts, 02111
University of North Carolina at Chapel Hill - Nephrology and Hypertension
Chapel Hill, North Carolina, 27599
NANI Research
Oak Brook, Illinois, 60523
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Australia4 sites
The St. George Hospital
Kogarah, New South Wales, 2217
Monash Health- Monash Medical Centre
Melbourne, Victoria, 3168
Sunshine Hospital
St Albans, Victoria, 3021
Prince of Wales Hospital
Sydney, New South Wales, 2031
Brazil4 sites
NUPEC Cardio
Belo Horizonte, Minas Gerais, 30220-140
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074
Universidade Federal de Sao Paulo
São Paulo, São Paulo, 04038-002
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-000
Malaysia4 sites
Universiti Kebangsaan Malaysia (UKM) - Medical Centre (Pusat Perubatan) (Hospital Canselor Tuanku Muhriz (HCTM))
Cheras, Kuala Lumpur, 56000
Hospital Raja Permaisuri Bainun (HRPB)
Ipoh, Perak, 30450
Hopsital Sultanah Aminah Johor Bharu (HSAJB) - Bangunan Bakawali Heodialysis Centre
Johor Bahru, Johor Darul Takzim, 80100
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
South Korea4 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068
Dong-A University Medical Center (Dong-A University Hospital)
Busan, Busan, 49201
Soon Chun Hyang Central Medical Center (SCHMC) - Soon Chun Hyang University Hospital
Cheonan, Chungnam-Do, 31151
Chung-Ang University College
Seoul, Seoul, 06973
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy on Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i)
The ASSIST study was 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).
Read the detailed description
Patients with biopsy-proven IgAN who were 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, were randomized to either sequence Atrasentan/Placebo or sequence Placebo/Atrasentan in which they received 0.75 mg atrasentan once daily during one period (period A), complete a 12-week washout period, and then received matching placebo during the other period (period B) as determined by the randomization schema.
Subjects who were not on background SGLT2i therapy would first 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 remained 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 was to evaluate the efficacy of atrasentan vs. placebo while on background therapy with SGLT2i.
- Conditions
- IgA Nephropathy, Immunoglobulin A Nephropathy
- Being tested
- Atrasentan, Placebo
- Keywords
- Kidney Diseases, Kidney Disease, Chronic, Urologic Diseases, Glomerulonephritis, Glomerular Disease, Glomerulonephritis, IGA, Glomerulopathy, Immunoglobulin Disease
- Medical subject headings
- Glomerulonephritis, IGA, Kidney Diseases, Renal Insufficiency, Chronic, Urologic Diseases, Glomerulonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtrasentanDrug
Also called CHK-01, Atrasentan Hydrochloride, ABT-627
Period A (12 Weeks) - Film-coated tablet, Washout Period: 12 weeks, Period B (24 Weeks) - Placebo
AtrasentanDrug
Also called CHK-01, Atrasentan Hydrochloride, ABT-627
Period B (12 Weeks) - Placebo, Washout Period: 12 weeks, Period A (24 Weeks) - Film-coated tablet
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Sequence Atrasentan/Placebo | Experimental | 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) Receives: Drug: Atrasentan; Drug: Placebo |
| Sequence Placebo/Atrasentan | Experimental | 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) Receives: Drug: Atrasentan; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Proteinuria (UPCR From a 24-Hour Urine Collection) From Baseline to Week 12
Change in proteinuria from Baseline to Week 12 across both periods between atrasentan versus placebo. Proteinuria was assessed using the urine protein to creatinine ratio (UPCR) measured from a 24-hour urine collection.
Measured: From Baseline to Week 12
Secondary outcomes (3)
Percentage Change in Proteinuria (UPCR From a 24-Hour Urine Collection) From Baseline to Week 24 in Treatment Period 2.
Change in proteinuria from Baseline to Week 24 in Treatment Period 2 between atrasentan versus placebo. Proteinuria was assessed using the urine protein to creatinine ratio (UPCR) measured from a 24-hour urine collection.
Measured: From Baseline to Week 24 of Treatment Period 2
Number of Subjects With TEAE and TEAESI
Number of Subjects With Treatment-Emergent Adverse Events (TEAE) and Treatment-Emergent Adverse Events of Special Interest (TEAESI). Severity assessment of AEs was based on CTCAE (Common Terminology Criteria for Adverse Events).
Measured: From first dose of study treatment until end of study, up to 60 weeks
Plasma Concentration of Atrasentan
Blood samples were collected for the measurement of plasma concentrations of atrasentan.
Measured: Treatment Period 1: Pre-dose on Weeks 2, 6 and 12; Treatment Period 2: Pre-dose on Weeks 2, 6, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start20 Jul 2023
- Primary completion30 Jun 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834738
- Sponsor's protocol ID
- CEXV811A12201
- Other IDs
- CHK01-03, 2023-503828-13-00, 2023
- Acronym
- ASSIST
- Status last verified
- Jun 2026
- First submitted
- 18 Apr 2023
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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 Cotransporter-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.
PubMed 41904616Tunnicliffe 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.
PubMed 38299639
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy on Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i)
- ClinicalTrials.gov ID
- NCT05834738
- Acronym / sponsor ID
- ASSIST / CEXV811A12201
- Conditions
- IgA Nephropathy, Immunoglobulin A Nephropathy
- Keywords
- Kidney Diseases, Kidney Disease, Chronic, Urologic Diseases, Glomerulonephritis, Glomerular Disease, Glomerulonephritis, IGA, Glomerulopathy, Immunoglobulin Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Posted 20 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ASSIST study was 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).
Detailed description
Patients with biopsy-proven IgAN who were 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, were randomized to either sequence Atrasentan/Placebo or sequence Placebo/Atrasentan in which they received 0.75 mg atrasentan once daily during one period (period A), complete a 12-week washout period, and then received matching placebo during the other period (period B) as determined by the randomization schema.
Subjects who were not on background SGLT2i therapy would first 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 remained 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 was to evaluate the efficacy of atrasentan vs. placebo while on background therapy with SGLT2i.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence Atrasentan/Placebo | Experimental | Drug: Atrasentan, Drug: PlaceboOnce 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 Placebo/Atrasentan | Experimental | Drug: Atrasentan, Drug: PlaceboOnce 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtrasentanAlso: CHK-01, Atrasentan Hydrochloride, ABT-627Period A (12 Weeks) - Film-coated tablet, Washout Period: 12 weeks, Period B (24 Weeks) - Placebo | Drug | Sequence Atrasentan/Placebo |
| AtrasentanAlso: CHK-01, Atrasentan Hydrochloride, ABT-627Period B (12 Weeks) - Placebo, Washout Period: 12 weeks, Period A (24 Weeks) - Film-coated tablet | Drug | Sequence Placebo/Atrasentan |
| PlaceboPlacebo | Drug | Sequence Atrasentan/Placebo, Sequence Placebo/Atrasentan |
Primary outcome
Percentage Change in Proteinuria (UPCR From a 24-Hour Urine Collection) From Baseline to Week 12
Time frame: From Baseline to Week 12
Change in proteinuria from Baseline to Week 12 across both periods between atrasentan versus placebo. Proteinuria was assessed using the urine protein to creatinine ratio (UPCR) measured from a 24-hour urine collection.
3 secondary outcomes
Percentage Change in Proteinuria (UPCR From a 24-Hour Urine Collection) From Baseline to Week 24 in Treatment Period 2.
Time frame: From Baseline to Week 24 of Treatment Period 2
Number of Subjects With TEAE and TEAESI
Time frame: From first dose of study treatment until end of study, up to 60 weeks
Plasma Concentration of Atrasentan
Time frame: Treatment Period 1: Pre-dose on Weeks 2, 6 and 12; Treatment Period 2: Pre-dose on Weeks 2, 6, 12 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41904616Heerspink 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 Cotransporter-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.
- Derived from this study: PubMed 38299639Tunnicliffe 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
30 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atrasentan in people with IgA Nephropathy and Immunoglobulin A Nephropathy, run by Novartis Pharmaceuticals at 30 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Spain, United States, Australia, Brazil, Malaysia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Proteinuria (UPCR From a 24-Hour Urine Collection) From Baseline to Week 12 (time frame: From Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05834738, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.