Berger DiseasePhase 3ADVANCENCT07498335
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
A Phase 3 study testing Drug: Atrasentan in people with Berger Disease and Bergers Disease, run by Novartis Pharmaceuticals at 23 sites in 8 countries.
Trial summary
A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to <18 years with primary immunoglobulin A nephropathy (IgAN). Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Berger Disease, Bergers Disease, IgA Nephropathy
- What is being tested?
- Drug: Atrasentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 6 Aug 2026to 13 Dec 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent by parent(s)/legal guardian(s) for the pediatric patient must be obtained before any study-specific assessment is performed. A consent or assent may also be required for some participants depending upon their age and local requirement.
- Male and female participants 2 to < 18 years of age as of Day 1.
- eGFR ≥ 30 mL/min/1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period.
- Kidney biopsy-proven primary IgAN*, with biopsy performed within 3 years of Screening with < 50% tubulointerstitial fibrosis and < 25% crescents. In case a kidney biopsy within 3 years from Screening is not available, a kidney biopsy may be performed if it is part of the planned diagnostic approach and clinical management of the participant.
- Proteinuria due to primary diagnosis of IgAN as assessed by UPCR ≥ 1 g/g (113 mg/mmoL) sampled from FMV at Screening on Day -90 and Day -60 as well as during the Run-in Period despite treatment with maximum tolerated dose of ACE inhibitor/ARB for at least 120 days prior to Day 1. Note: UPCR will be assessed based on one FMV sample at Day -90 and based on the geometric mean of 2 FMV samples for the Day -60 visit and during the Run-in Period.
- All participants must have been on supportive care including stable dose regimen of ACE inhibitor or ARB at either the locally approved maximal daily dose per body weight, or the maximally tolerated dose (per Investigator's judgment for pediatric use), for at least 120 days before first study drug administration. In addition, if participants are taking diuretics, other antihypertensive medication, or other background medication for IgAN (such as SGLT2 inhibitors), the doses should also be stabilized for at least 120 days prior to the first dosing of study treatment. Note: Participants with allergies or intolerance to ACE inhibitors and ARBs are eligible for the study. Participants with allergies or intolerance to RAS inhibitors are eligible but will not exceed ~5% of the total population treated (maximum of 2 participants).
- The minimum body weight of enrolled pediatric participants is 10 kg at Screening and confirmed on Day 1.
- Parent(s)/guardian(s) are to be able to communicate well with the investigator and to understand and comply with the study's requirements for their child.
Who cannot join
- Participation in any other investigational drug trial or use of other investigational drugs at the time of enrollment, or within 5 elimination half-lives of enrollment, or within 30 days of enrollment, whichever is longer; or longer if required by local regulations.
- History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
- Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, Herpes Simplex virus infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, and familial mediterranean fever before treatment.
- A clinical diagnosis of IgA vasculitis (IgAV or Henoch-Schoenlein purpura) based on typical palpable purpura with or without arthralgia and abdominal pain.
- Evidence of significant urinary obstruction or difficulty in voiding, any urinary tract disorder causing significant urinary obstruction or difficulty in voiding at Screening and confirmed at Baseline/Day 1.
- Concurrent diagnosis of CKD other than IgAN at Screening and before first study drug administration.
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- Current acute kidney injury (AKI) defined by Acute Kidney Injury Network (AKIN) criteria within 4 weeks of Screening.
- Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to Screening or during Screening and Run-in periods.
- Presence of nephrotic syndrome at Screening based on the investigator's judgement.
- BNP value of >200 pg/mL at Screening.
- Hemoglobin below 9 g/dL at Screening or prior history of blood transfusion for anemia within 3 months of Screening.
- Platelet count <80,000/μL at Screening.
- On Day 1 participants' body weight falls below the lower limit of the cohort in which the participant was initially screened and lower body weight cohort is not open for enrollment.
- Known history of congenital heart disease, heart failure or clinically significant fluid retention such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites before treatment.
- Current use of any homeopathic and/or herbal medications for the treatment of IgAN disease , such as but not limited to Tripterygium wilfordii (Lei Gong Teng), Caulis sinomenii and Sinomenium acutum before treatment.
- History of an alcohol or illicit drug-related disorder within the past 3 years at Screening.
- Confirmed blood pressure >150 mmHg systolic or >95 mmHg diastolic for 12 to <18 years of age; >140 mmHg systolic or >90 mmHg diastolic for 6 to <12 years of age; >120 mmHg systolic or >80 mmHg diastolic for 2 to <6 years of age; based on the mean of 3 measurements obtained at Screening; or clinically significant hypotension at screening.
- Participants previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), calcineurin inhibitors, complement inhibitors, oral budesonide in any dose, systemic corticosteroid exposure ≥0.5 mg/kg/day or > 7.5 mg total exposure in a single day of prednisone/prednisolone equivalent within 120 days (or 180 days for rituximab) prior to first study drug administration.
- Participants treated with endothelin (receptor) antagonists (including sparsentan) within 120 days prior to first study drug administration.
- History of organ transplantation (subjects with history of corneal transplant are not excluded) before treatment.
- Major concurrent comorbidities before treatment including but not limited to advanced cardiac disease (e.g., NYHA class III (for ages 6 to <18 years), Ross class III (for ages 2 to <6years)), severe pulmonary disease (e.g., WHO class III (for age 17 years); Pulmonary Vascular Research Institute (PVRI) class III (for 2-<17 years)), or hepatic disease (e.g., active hepatitis) that in the opinion of the investigator precludes subject's participation in the study.
- Any medical condition deemed likely to interfere with the subject's participation in the study before treatment.
- Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration.
- Presence of fever ≥ 38°C (100.4°F) within 7 days prior to study drug administration.
- Human immunodeficiency virus (HIV) infection (known history of HIV or test positive for HIV antibody at Screening).
- Liver disease, such as active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as Hepatitis B surface antigen (HBsAg) positive or Hepatitis C virus ribonucleic acid (HCV-RNA) positive at Screening, or liver injury as indicated by abnormal liver function tests at Screening and Baseline as defined below:
- Any single parameter of ALT, AST, GGT, alkaline phosphatase must not exceed 3X upper limit of normal (ULN)
- Serum bilirubin must not exceed 2X ULN
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer treated with curative intent), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases; for children aged 2 to <5 years of age, history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, inclusive of malignancies diagnosed at birth and during the neonatal and childhood time, regardless of whether there is evidence of local recurrence or metastases.
- Pregnant or nursing (lactating) female participants (of childbearing potential), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test at Screening.
- Subjects taking prohibited therapies before treatment.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 1 month after stopping study treatment.
- Highly effective contraception methods include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.
- Bilateral tubal occlusion, Bilateral tubal ligation (at least six weeks before taking study treatment).
- Sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to screening provided partner(s) has(have) received medical confirmation of surgical success.
- Use of hormonal contraception methods:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal.
- Progestogen-only hormonal contraception (where inhibition of ovulation is not the primary or only mode of action): oral, injectable or implantable.
- Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking study treatment. If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the ICF. 30. For fertile male participants, participants must not intend to father a child or donate sperm while taking study treatment and at least 1 month afterward for males.
- All fertile male participants in a sexual relationship with a WOCBP must agree to the use of a condom during the trial and for up to one month after last study drug administration. A male participant is considered fertile after puberty unless permanently sterile by bilateral orchidectomy/orchiectomy.
Trial locations and contacts
23 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
23 sites in 8 countries
United States4 sites, 4 recruiting
- Not yet recruiting
Cincinnati Childrens Hospital MC
Cincinnati, Ohio, 45229
- Not yet recruiting
University of Tennessee Health Science Center- Le Bonheur Research Center
Memphis, Tennessee, 38105
- Not yet recruiting
Hackensack Meridian Health
Neptune City, New Jersey, 07753
- Not yet recruiting
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
France4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Bron, 69677
- Recruiting
Novartis Investigative Site
Nantes, 44093
- Recruiting
Novartis Investigative Site
Paris, 75019
- Recruiting
Novartis Investigative Site
Toulouse, 31059
Japan4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Chiba, 2608712
- Recruiting
Novartis Investigative Site
Fukuoka, 8158555
- Recruiting
Novartis Investigative Site
Kanazawa, Ishikawa-ken, 9208650
- Recruiting
Novartis Investigative Site
Nagoya, Aichi-ken, 4578510
Spain4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Barcelona, 08035
- Recruiting
Novartis Investigative Site
Cadiz, Andalusia, 11009
- Recruiting
Novartis Investigative Site
Madrid, 28041
- Recruiting
Novartis Investigative Site
Madrid, 28046
China2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Beijing, 100034
- Recruiting
Novartis Investigative Site
Xi'an, 710054
Colombia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Barranquilla, Atlántico, 080020
- Recruiting
Novartis Investigative Site
Medellín, Antioquia, 050001
Taiwan2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Taipei, 10002
- Recruiting
Novartis Investigative Site
Taoyuan, 33305
South Korea1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Seoul, Seoul, 03080
About this study
Official title: A Single-arm, Multicenter, Phase III Study to Assess Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients of 2 to <18 Years of Age With Primary Immunoglobulin A Nephropathy (IgAN)
A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to <18 years with primary immunoglobulin A nephropathy (IgAN).
Read the detailed description
This Phase III study aims to address the unmet medical need in pediatric primary IgAN by assessing the efficacy, pharmacokinetics, safety, and tolerability of atrasentan in patients aged 2 to <18 years. Pediatric patients with biopsy-confirmed IgAN will receive atrasentan (0.75 mg or a body-weight-adjusted dose) for up to 104 weeks while taking the maximally tolerated and stable dose of a RAS (renin-angiotensin system) inhibitor [such as angiotensin converting enzyme inhibitor (ACEi) or angiotensin-receptor antagonist (ARB)] as part of standard of care, if possible.
The primary objective of the study is to evaluate the effect of atrasentan in reducing proteinuria from Baseline to Week 36. UPCR will be measured based on the geometric mean of 2 FMVs obtained during the Run-in period and preceding each scheduled visit.
The study will enroll pediatric patients in a staggered approach. The approach will be to first enroll a subset of Cohort 1 (≥40 kg of body weight) patients to collect safety data, tolerability data, PK data and biomarker data for up to 104 weeks (EOS). Confirmatory PK and safety review will be held at multiple timepoints throughout the trial. There is a data monitoring committee (DMC) which will function independently of all other individuals associated with the conduct of this clinical trial, including the site investigators participating in the study. The DMC will assess at defined intervals the progress of a clinical trial, safety data and recommend to the study team whether to continue, modify, or terminate the trial.
Subjects who complete treatment through Week 104 and complete the study may be eligible to enroll in the open label extension of the study to receive atrasentan 0.75 mg or a body-weight adjusted appropriate dose.
- Conditions
- Berger Disease, Bergers Disease, IgA Nephropathy, Immunoglobulin A Nephropathy, Primary IgAN, Nephritis IgA Type, Nephropathy IgA Type
- Being tested
- Drug: Atrasentan
- Keywords
- Kidney Diseases, Kidney Disease, Chronic, Glomerulonephritis, Urologic Diseases, Glomerular Disease, Glomerulonephritis, IGA, Glomerulopathy, Immunoglobulin Disease, Atrasentan
- Medical subject headings
- Glomerulonephritis, IGA, Kidney Diseases, Renal Insufficiency, Chronic, Glomerulonephritis, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: AtrasentanDrug
- 104 Weeks - Film-coated tablet
- Other Names:
Atrasentan Hydrochloride ABT-627
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (≥40 kg of body weight) | Experimental | Once daily oral administration of 0.75 mg atrasentan for 104 weeks Receives: Drug: Drug: Atrasentan |
| Cohort 2 (30 to <40 kg of body weight) | Experimental | Oral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks Receives: Drug: Drug: Atrasentan |
| Cohort 3 (20 to <30 kg of body weight) | Experimental | Oral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks Receives: Drug: Drug: Atrasentan |
| Cohort 4 (10 to <20kg of body weight) | Experimental | Oral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks Receives: Drug: Drug: Atrasentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Proteinuria at Week 36
The change in urine protein: creatinine ratio (UPCR) from baseline to Week 36
Measured: Baseline and 36 weeks
Secondary outcomes (6)
Change from Baseline in Proteinuria at Week 36 in participants who experienced ≤ 30% decrease in proteinuria during the 60-day period prior to atrasentan initiation
All cohorts combined
Measured: Baseline and 36 weeks
PK parameters: Cmaxss
Cmaxss: The maximum (peak) observed plasma concentration (mass x volume-1)
Measured: Baseline and week 104
PK parameters: AUCss
AUCss: The AUC calculated during a dosing interval at steady state (amount x time x volume-1)
Measured: Baseline and week 104
PK parameters: CLss/F
CLss/F: Apparent total plasma clearance of after extravascular administration at steady state. (volume x time-1)
Measured: Baseline and week 104
PK parameters: Ctrough
Ctrough: The pre-dose plasma concentration observed during a dosing interval (mass x volume-1)
Measured: Baseline and week 104
Number of participants with AEs
Number of participants with AEs and SAEs including abnormal laboratory parameters, and vital signs
Measured: Baseline and week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start6 Aug 2026
- Primary completion15 Sep 2031 (estimated)
- Study completion13 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Berger DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
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
- NCT07498335
- Sponsor's protocol ID
- CEXV811B12301
- Acronym
- ADVANCE
- Status last verified
- Nov 2026
- First submitted
- 23 Mar 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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, Jardine M, Kohan DE, Lafayette RA, Levin A, Liew A, Zhang H, Lodha A, Gray T, Wang Y, Renfurm R, Barratt J; ALIGN Study Investigators. Atrasentan in Patients with IgA Nephropathy. N Engl J Med. 2025 Feb 6;392(6):544-554. doi: 10.1056/NEJMoa2409415. Epub 2024 Oct 25.
PubMed 39460694
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Phase III Study to Assess Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients of 2 to <18 Years of Age With Primary Immunoglobulin A Nephropathy (IgAN)
- ClinicalTrials.gov ID
- NCT07498335
- Acronym / sponsor ID
- ADVANCE / CEXV811B12301
- Conditions
- Berger Disease, Bergers Disease, IgA Nephropathy, Immunoglobulin A Nephropathy, Primary IgAN, Nephritis IgA Type, Nephropathy IgA Type
- Keywords
- Kidney Diseases, Kidney Disease, Chronic, Glomerulonephritis, Urologic Diseases, Glomerular Disease, Glomerulonephritis, IGA, Glomerulopathy, Immunoglobulin Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 15 Sep 2031 (estimated)
- Study completion
- 13 Dec 2032 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to <18 years with primary immunoglobulin A nephropathy (IgAN).
Detailed description
This Phase III study aims to address the unmet medical need in pediatric primary IgAN by assessing the efficacy, pharmacokinetics, safety, and tolerability of atrasentan in patients aged 2 to <18 years. Pediatric patients with biopsy-confirmed IgAN will receive atrasentan (0.75 mg or a body-weight-adjusted dose) for up to 104 weeks while taking the maximally tolerated and stable dose of a RAS (renin-angiotensin system) inhibitor [such as angiotensin converting enzyme inhibitor (ACEi) or angiotensin-receptor antagonist (ARB)] as part of standard of care, if possible.
The primary objective of the study is to evaluate the effect of atrasentan in reducing proteinuria from Baseline to Week 36. UPCR will be measured based on the geometric mean of 2 FMVs obtained during the Run-in period and preceding each scheduled visit.
The study will enroll pediatric patients in a staggered approach. The approach will be to first enroll a subset of Cohort 1 (≥40 kg of body weight) patients to collect safety data, tolerability data, PK data and biomarker data for up to 104 weeks (EOS). Confirmatory PK and safety review will be held at multiple timepoints throughout the trial. There is a data monitoring committee (DMC) which will function independently of all other individuals associated with the conduct of this clinical trial, including the site investigators participating in the study. The DMC will assess at defined intervals the progress of a clinical trial, safety data and recommend to the study team whether to continue, modify, or terminate the trial.
Subjects who complete treatment through Week 104 and complete the study may be eligible to enroll in the open label extension of the study to receive atrasentan 0.75 mg or a body-weight adjusted appropriate dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (≥40 kg of body weight) | Experimental | Drug: Drug: AtrasentanOnce daily oral administration of 0.75 mg atrasentan for 104 weeks |
| Cohort 2 (30 to <40 kg of body weight) | Experimental | Drug: Drug: AtrasentanOral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks |
| Cohort 3 (20 to <30 kg of body weight) | Experimental | Drug: Drug: AtrasentanOral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks |
| Cohort 4 (10 to <20kg of body weight) | Experimental | Drug: Drug: AtrasentanOral administration of weight-based appropriate dose(s) (that may be modified based on emerging data) for 104 weeks |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Signed informed consent by parent(s)/legal guardian(s) for the pediatric patient must be obtained before any study-specific assessment is performed. A consent or assent may also be required for some participants depending upon their age and local requirement.
- Male and female participants 2 to < 18 years of age as of Day 1.
- eGFR ≥ 30 mL/min/1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period.
- Kidney biopsy-proven primary IgAN*, with biopsy performed within 3 years of Screening with < 50% tubulointerstitial fibrosis and < 25% crescents. In case a kidney biopsy within 3 years from Screening is not available, a kidney biopsy may be performed if it is part of the planned diagnostic approach and clinical management of the participant.
- Proteinuria due to primary diagnosis of IgAN as assessed by UPCR ≥ 1 g/g (113 mg/mmoL) sampled from FMV at Screening on Day -90 and Day -60 as well as during the Run-in Period despite treatment with maximum tolerated dose of ACE inhibitor/ARB for at least 120 days prior to Day 1. Note: UPCR will be assessed based on one FMV sample at Day -90 and based on the geometric mean of 2 FMV samples for the Day -60 visit and during the Run-in Period.
Key exclusion criteria (42 listed)
- Participation in any other investigational drug trial or use of other investigational drugs at the time of enrollment, or within 5 elimination half-lives of enrollment, or within 30 days of enrollment, whichever is longer; or longer if required by local regulations.
- History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
- Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, Herpes Simplex virus infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, and familial mediterranean fever before treatment.
- A clinical diagnosis of IgA vasculitis (IgAV or Henoch-Schoenlein purpura) based on typical palpable purpura with or without arthralgia and abdominal pain.
- Evidence of significant urinary obstruction or difficulty in voiding, any urinary tract disorder causing significant urinary obstruction or difficulty in voiding at Screening and confirmed at Baseline/Day 1.
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 |
|---|---|---|
| Drug: Atrasentan* 104 Weeks - Film-coated tablet * Other Names: Atrasentan Hydrochloride ABT-627 | Drug | Cohort 1 (≥40 kg of body weight), Cohort 2 (30 to <40 kg of body weight), Cohort 3 (20 to <30 kg of body weight), Cohort 4 (10 to <20kg of body weight) |
Primary outcome
Change From Baseline in Proteinuria at Week 36
Time frame: Baseline and 36 weeks
The change in urine protein: creatinine ratio (UPCR) from baseline to Week 36
6 secondary outcomes
Change from Baseline in Proteinuria at Week 36 in participants who experienced ≤ 30% decrease in proteinuria during the 60-day period prior to atrasentan initiation
Time frame: Baseline and 36 weeks
PK parameters: Cmaxss
Time frame: Baseline and week 104
PK parameters: AUCss
Time frame: Baseline and week 104
PK parameters: CLss/F
Time frame: Baseline and week 104
PK parameters: Ctrough
Time frame: Baseline and week 104
Number of participants with AEs
Time frame: Baseline and week 104
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 39460694Heerspink HJL, Jardine M, Kohan DE, Lafayette RA, Levin A, Liew A, Zhang H, Lodha A, Gray T, Wang Y, Renfurm R, Barratt J; ALIGN Study Investigators. Atrasentan in Patients with IgA Nephropathy. N Engl J Med. 2025 Feb 6;392(6):544-554. doi: 10.1056/NEJMoa2409415. Epub 2024 Oct 25.
- 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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Drug: Atrasentan in people with Berger Disease and Bergers Disease, run by Novartis Pharmaceuticals at 23 sites in 8 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 8 inclusion and 42 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, France, Japan, Spain, China and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Proteinuria at Week 36 (time frame: Baseline and 36 weeks). 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 NCT07498335, which also lists 1 linked publication.
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 6 Nov 2026.