IgA NephropathyPhase 2AFFINITYNCT04573920
Atrasentan in Patients With Proteinuric Glomerular Diseases
A Phase 2 study testing Atrasentan in people with IgA Nephropathy and Focal Segmental Glomerulosclerosis, run by Novartis Pharmaceuticals at 33 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy, Focal Segmental Glomerulosclerosis, Alport Syndrome
- What is being tested?
- Atrasentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 33 sitesin 6 countries
- Study dates
- 15 Mar 2021to 27 Oct 2026
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Biopsy-proven IgA nephropathy
- UPCR between 0.5 to less than 1.0 g/g
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- Screening eGFR ≥ 30 mL/min/1.73 m2
- For patients enrolling in FSGS Cohort:
- Biopsy-proven FSGS or documented genetic mutation in a podocyte protein associated with FSGS
- UPCR > 1.0 g/g
- Screening eGFR ≥ 30 mL/min/1.73 m2
- Subjects receiving systemic corticosteroids or other immunosuppressants must be on a stable dose for at least 12 weeks.
- BMI ≤ 40 kg/m2
- For patients enrolling in Alport syndrome Cohort:
- Diagnosis of Alport syndrome by genetic testing
- UPCR > 0.5 g/g
- Screening eGFR ≥ 30 mL/min/1.73 m2
- For patients enrolling in DKD Cohort:
- Diagnosis of type 2 diabetes mellitus
- UACR ≥ 0.5 g/g
- Screening eGFR ≥ 45 mL/min/1.73 m2
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
United States14 sites
Mountain Kidney And Hyper Associa
Asheville, North Carolina, 28801
Tufts Medical Center
Boston, Massachusetts, 02111
Baylor Scott and White
Dallas, Texas, 75246
Colorado Kidney Care Nephrology
Denver, Colorado, 80230
Kidney Disease Medical Group
Glendale, California, 91206
Prolato Clinical Research Center
Houston, Texas, 77054
DaVita Clinical Research
Las Vegas, Nevada, 89146
Academic Medical Research Institute
Los Angeles, California, 90022
Uni of Minnesota Hos and Clinics
Minneapolis, Minnesota, 55455
North America Research Institute
San Dimas, California, 91773
Northwest Louisiana Nephrology Research
Shreveport, Louisiana, 71101-4440
Stanford U School Of Medicine
Stanford, California, 94305
Milwaukee Nephrologists SC
Wauwatosa, Wisconsin, 53226
Brookview Hills Research Assoc
Winston-Salem, North Carolina, 27103
Australia6 sites
Novartis Investigative Site
Clayton, Victoria, 3168
Novartis Investigative Site
Gosford, New South Wales, 2250
Novartis Investigative Site
Herston, Queensland, 4029
Novartis Investigative Site
Reservoir, Victoria, 3073
Novartis Investigative Site
St Albans, Victoria, 3021
Novartis Investigative Site
St Leonards, 2065
South Korea5 sites
Novartis Investigative Site
Anyang-si, Gyeonggi-do, 14068
Novartis Investigative Site
Cheonan, Chungcheongnam-do, 330-721
Novartis Investigative Site
Seoul, Korea, 02841
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 134 727
Spain5 sites
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Lugo, 27004
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Majadahonda, 28222
Novartis Investigative Site
Port de Sagunt, Valencia, 46520
United Kingdom2 sites
Novartis Investigative Site
London, E1 1BB
Novartis Investigative Site
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: A Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular Diseases
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.
Read the detailed description
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. Cohorts will consist of patients with:
- IgA nephropathy (IgAN) with urine protein:creatinine ratio (UPCR) of 0.5 to less than 1.0 g/g
- Focal segmental glomerulosclerosis (FSGS)
- Alport syndrome
- Diabetic kidney disease (DKD) on top of background care of a RAS inhibitor and SGLT2 inhibitor
Additional cohorts may be added as data is available.
Approximately 100 patients will be enrolled in the study. Approximately 20 patients will be enrolled in each cohort to receive 0.75 mg atrasentan QD for 52 weeks. The study will also evaluate efficacy and safety of 1.5 mg atrasentan QD in FSGS subjects who received 0.75 mg atrasentan and it was well tolerated.
Patients will be allowed to continue into treatment extension and receive oral atrasentan QD for up to an additional 84 weeks (total maximum treatment of 188 weeks),
The primary objective of the study is to evaluate the effect of atrasentan on proteinuria (for IgAN, FSGS, and Alport syndrome patients) or albuminuria (for DKD patients) levels. Exploratory objectives include evaluating the change in kidney function over time as measured by eGFR, safety and tolerability. To facilitate study participation over this time period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.
- Conditions
- IgA Nephropathy, Focal Segmental Glomerulosclerosis, Alport Syndrome, Diabetic Kidney Disease, Diabetic Nephropathy Type 2, Immunoglobulin A Nephropathy
- Being tested
- Atrasentan
- Medical subject headings
- Glomerulonephritis, IGA, Glomerulosclerosis, Focal Segmental, Nephritis, Hereditary, Diabetic Nephropathies
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
Film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| Atrasentan 0.75 mg | Experimental | Once daily oral administration of 0.75 mg atrasentan Receives: Drug: Atrasentan |
| Atrasentan 1.5 mg | Experimental | Once daily oral administration 1.5 mg atrasentan (FSGS cohorts only) Receives: Drug: Atrasentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proteinuria for IgAN, FSGS, and Alport syndrome patients receiving 0.75 mg atrasentan QD
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 12
Measured: Up to Week 12 or approximately 3 months
Change in albuminuria for DKD patients
The change in urine albumin:creatinine ratio (UACR) from baseline to Week 12
Measured: Up to Week 12 or approximately 3 months
Change in proteinuria for FSGS patients at 1.5 mg dose
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 24
Measured: Up to Week 24 or approximately 6 months
Change in proteinuria for FSGS patients at 1.5 mg dose
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 30
Measured: Up to Week 30 or approximately 7.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start15 Mar 2021
- Primary completion2 Jul 2024
- Study completion27 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 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
- NCT04573920
- Sponsor's protocol ID
- CEXV811C12201
- Acronym
- AFFINITY
- Status last verified
- May 2026
- First submitted
- 28 Sep 2020
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuo JJ, Wu J, Gunawan MG, McConnell MT, Lester J, Naidu NA, Nieh CH, Surendradoss J, Kano T, Suzuki Y, Olson NE, Cox JH. Effects of Atrasentan on Kidney Gene Transcription, Mesangial Cell Proliferation, and Proteinuria in IgA Nephropathy. Kidney360. 2026 May 1;7(5):1003-1016. doi: 10.34067/KID.0000001000. Epub 2025 Dec 24.
PubMed 41442197Rheault MN. Treatment Approaches for Alport Syndrome. J Am Soc Nephrol. 2026 Jan 1;37(1):172-179. doi: 10.1681/ASN.0000000897. Epub 2025 Sep 12.
PubMed 40938675Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.
PubMed 39899371Obadina M, Wilson S, Derebail VK, Little J. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations. Kidney360. 2023 Jul 1;4(7):997-1005. doi: 10.34067/KID.0000000000000162. Epub 2023 May 31.
PubMed 37254256
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular Diseases
- ClinicalTrials.gov ID
- NCT04573920
- Acronym / sponsor ID
- AFFINITY / CEXV811C12201
- Conditions
- IgA Nephropathy, Focal Segmental Glomerulosclerosis, Alport Syndrome, Diabetic Kidney Disease, Diabetic Nephropathy Type 2, Immunoglobulin A Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 27 Oct 2026 (estimated)
- First posted
- 5 Oct 2020 (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.
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.
Detailed description
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. Cohorts will consist of patients with:
- IgA nephropathy (IgAN) with urine protein:creatinine ratio (UPCR) of 0.5 to less than 1.0 g/g
- Focal segmental glomerulosclerosis (FSGS)
- Alport syndrome
- Diabetic kidney disease (DKD) on top of background care of a RAS inhibitor and SGLT2 inhibitor
Additional cohorts may be added as data is available.
Approximately 100 patients will be enrolled in the study. Approximately 20 patients will be enrolled in each cohort to receive 0.75 mg atrasentan QD for 52 weeks. The study will also evaluate efficacy and safety of 1.5 mg atrasentan QD in FSGS subjects who received 0.75 mg atrasentan and it was well tolerated.
Patients will be allowed to continue into treatment extension and receive oral atrasentan QD for up to an additional 84 weeks (total maximum treatment of 188 weeks),
The primary objective of the study is to evaluate the effect of atrasentan on proteinuria (for IgAN, FSGS, and Alport syndrome patients) or albuminuria (for DKD patients) levels. Exploratory objectives include evaluating the change in kidney function over time as measured by eGFR, safety and tolerability. To facilitate study participation over this time period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrasentan 0.75 mg | Experimental | Drug: AtrasentanOnce daily oral administration of 0.75 mg atrasentan |
| Atrasentan 1.5 mg | Experimental | Drug: AtrasentanOnce daily oral administration 1.5 mg atrasentan (FSGS cohorts only) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
- For patients enrolling in FSGS Cohort:
Key exclusion criteria (13 listed)
- 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.
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-627Film-coated tablet | Drug | Atrasentan 0.75 mg, Atrasentan 1.5 mg |
Primary outcome
Change in proteinuria for IgAN, FSGS, and Alport syndrome patients receiving 0.75 mg atrasentan QD
Time frame: Up to Week 12 or approximately 3 months
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 12
Change in albuminuria for DKD patients
Time frame: Up to Week 12 or approximately 3 months
The change in urine albumin:creatinine ratio (UACR) from baseline to Week 12
Change in proteinuria for FSGS patients at 1.5 mg dose
Time frame: Up to Week 24 or approximately 6 months
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 24
Change in proteinuria for FSGS patients at 1.5 mg dose
Time frame: Up to Week 30 or approximately 7.5 months
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 30
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 1 Jun 2026.
- Derived from this study: PubMed 41442197Kuo JJ, Wu J, Gunawan MG, McConnell MT, Lester J, Naidu NA, Nieh CH, Surendradoss J, Kano T, Suzuki Y, Olson NE, Cox JH. Effects of Atrasentan on Kidney Gene Transcription, Mesangial Cell Proliferation, and Proteinuria in IgA Nephropathy. Kidney360. 2026 May 1;7(5):1003-1016. doi: 10.34067/KID.0000001000. Epub 2025 Dec 24.
- Derived from this study: PubMed 40938675Rheault MN. Treatment Approaches for Alport Syndrome. J Am Soc Nephrol. 2026 Jan 1;37(1):172-179. doi: 10.1681/ASN.0000000897. Epub 2025 Sep 12.
- Derived from this study: PubMed 39899371Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.
- Derived from this study: PubMed 37254256Obadina M, Wilson S, Derebail VK, Little J. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations. Kidney360. 2023 Jul 1;4(7):997-1005. doi: 10.34067/KID.0000000000000162. Epub 2023 May 31.
- Individual participant dataSharing planned: No
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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
33 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 Focal Segmental Glomerulosclerosis, run by Novartis Pharmaceuticals at 33 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 23 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Australia, South Korea, Spain, United Kingdom 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?
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?
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?
Change in proteinuria for IgAN, FSGS, and Alport syndrome patients receiving 0.75 mg atrasentan QD (time frame: Up to Week 12 or approximately 3 months). The study lists 4 primary outcomes in all. 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 NCT04573920, which also lists 4 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 1 Jun 2026.