Lupus NephritisPhase 3IRISNCT05138133
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
A Phase 3 study testing Anifrolumab in people with Lupus Nephritis, run by AstraZeneca at 164 sites in 24 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Anifrolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 363 participants
- Where
- 164 sitesin 24 countries
- Study dates
- 15 Feb 2022to 4 Oct 2028
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
- Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
- Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol)
- eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
- Fulfills updated 2019 EULAR/ACR SLE classification criteria.
- No signs of symptoms of active TB prior to or during screening or no treatment for latent TB
Who cannot join
- A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
- Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1).
- Evidence of hepatitis C or active hepatitis B.
- Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
- Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide > 2 pulses of high-dose (≥ 0.5 g/m2) or > 4 doses of low dose (500 mg every 2 weeks) or Average MMF > 2.5 g/day (or > 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus > 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF.
- Previous receipt of >◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
- Known intolerance to ≤ 1.0 g/day of MMF.
- Any history of severe COVID-19 infection.
Trial locations and contacts
164 sites in 24 countries.
164 sites in 24 countries
China23 sites
Research Site
Beijing, 100034
Research Site
Beijing, 100044
Research Site
Bengbu, 233004
Research Site
Chengdu, 610072
Research Site
Guangzhou, 510530
Research Site
Haikou, 570311
Research Site
Hangzhou, 310009
Research Site
Jinan, 250021
Research Site
Jining, 272011
Research Site
Nanchang, 330006
Research Site
Nanjing, 210009
Research Site
Nanjing, 210029
Research Site
Nanning, 530021
Research Site
Shanghai, 200025
Research Site
Shanghai, 200040
Research Site
Shengyang, 110004
Research Site
Shenzhen, 518036
Research Site
Shijiazhuang, 050001
Research Site
Tianjin, 300201
Research Site
Wuhan, 430060
Research Site
Wuxi, 214023
Research Site
Xi'an, 710061
Research Site
Zhengzhou, 450000
United States16 sites
Research Site
Atlanta, Georgia, 30308
Research Site
Colleyville, Texas, 76034
Research Site
Edinburg, Texas, 78539
Research Site
El Paso, Texas, 79902
Research Site
Glendale, Arizona, 85306
Research Site
Houston, Texas, 77054
Research Site
La Palma, California, 90623
Research Site
Los Angeles, California, 90095
Research Site
Louisville, Kentucky, 40202
Research Site
Manhasset, New York, 11030
Research Site
Middleburg Heights, Ohio, 44130
Research Site
New York, New York, 10016
Research Site
Plantation, Florida, 33324
Research Site
Summit, New Jersey, 07901
Research Site
Upland, California, 91786
Research Site
Winston-Salem, North Carolina, 27157
Japan16 sites
Research Site
Bunkyō City, 113-8655
Research Site
Chiba, 260-8712
Research Site
Hiroshima, 734-8551
Research Site
Kita-gun, 761-0793
Research Site
Kitakyushu-shi, 807-8555
Research Site
Matsumoto-shi, 390-8621
Research Site
Nagasaki, 852-8501
Research Site
Okayama, 700-8558
Research Site
Ono, 675-1392
Research Site
Sagamihara-shi, 252-0375
Research Site
Sendai, 980-0872
Research Site
Shinagawa-ku, 142-0054
Research Site
Shinjuku-ku, 160-8582
Research Site
Shinjuku-ku, 162-8655
Research Site
Shinjuku-ku, 162-8666
Research Site
Toyoake-shi, 470-1192
Brazil11 sites
Research Site
Belo Horizonte, 30130 100
Research Site
Campinas, 13087-567
Research Site
Cuiabá, 78020-500
Research Site
Maringá, 87060-040
Research Site
Porto Alegre, 90035-903
Research Site
Recife, 50740-465
Research Site
Salvador, 40150-150
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 04014-002
Research Site
São Paulo, 04036-002
Research Site
São Paulo, 05403-000
India11 sites
Research Site
Ahmedabad, 380005
Research Site
Ahmedabad, 382421
Research Site
Dehradun, 248001
Research Site
Delhi, 110029
Research Site
Hyderabad, 500082
Research Site
Kolkata, 700020
Research Site
Nadiād, 387001
Research Site
Pune, 411001
Research Site
Secunderabad, 500003
Research Site
Vijayawada, 522002
Research Site
Visakapatnam, 530013
Turkey (Türkiye)9 sites
Research Site
Adapazarı, 54290
Research Site
Ankara, 06100
Research Site
Ankara
Research Site
Istanbul, 34865
Research Site
Istanbul
Research Site
Izmir, 35965
Research Site
Kahramanmaraş, 46100
Research Site
Kayseri, 38039
Research Site
Kocaeli, 41380
France7 sites
Research Site
Aurillac, 15002
Research Site
Bordeaux, 33076
Research Site
Marseille, 13005
Research Site
Paris, 75013
Research Site
Paris, 75018
Research Site
Strasbourg, 67098
Research Site
Toulouse, 31059
Taiwan7 sites
Research Site
Kaohsiung City, 833
Research Site
New Taipei City, 220
Research Site
Taichung, 40447
Research Site
Taichung, 40705
Research Site
Taipei, 11217
Research Site
Taipei, 114
Research Site
Taipei, 235
Germany6 sites
Research Site
Cologne, 50937
Research Site
Dresden, 1307
Research Site
Hanover, 30625
Research Site
Heidelberg, 69120
Research Site
Kirchheim, 73230
Research Site
Mainz Am Rhein, 55131
Malaysia6 sites
Research Site
Batu Caves, 68100
Research Site
Ipoh, 30450
Research Site
Kajang, 43000
Research Site
Kuala Lumpur, 59100
Research Site
Kuantan, 25100
Research Site
Taiping, 34000
Mexico6 sites
Research Site
Chihuahua City, 31000
Research Site
Guadalajara, 44160
Research Site
Guadalajara, 44650
Research Site
México, 06726
Research Site
México, 14080
Research Site
San Luis Potosí City, 78290
Peru6 sites
Research Site
Lima, 15023
Research Site
Lima, 15046
Research Site
Lima, 15102
Research Site
Lima, L34
Research Site
Lima, LIMA 27
Research Site
Lima, LIMA 29
Poland6 sites
Research Site
Lodz, 92-213
Research Site
Olsztyn, 10-561
Research Site
Opole, 46-020
Research Site
Poznan, 60-355
Research Site
Poznan, 61-545
Research Site
Rzeszów, 35-301
Argentina5 sites
Research Site
CABA, C1425EOE
Research Site
Ciudad de Buenos Aires, C1015ABO
Research Site
La Plata, 1900
Research Site
Rosario, S2000PBJ
Research Site
San Juan, 5400
Italy5 sites
Research Site
Ancona, 60126
Research Site
Cona, 44124
Research Site
Eboli, 84025
Research Site
Padova, 35128
Research Site
Roma, 00161
Thailand5 sites
Research Site
Bangkok, 10220
Research Site
Bangkok, 10330
Research Site
Hat Yai, 90110
Research Site
Muang, 50200
Research Site
Ratchathewi, 10400
Vietnam5 sites
Research Site
Hà Nội, 100000
Research Site
Hanoi, 100000
Research Site
Hanoi, 10000
Research Site
Ho Chi Minh City, 700000
Research Site
Hochiminh, 70000
Belgium3 sites
Research Site
Brussels, 1200
Research Site
Leuven, 3000
Research Site
Liège, 4000
Colombia3 sites
Research Site
Barranquilla, 080020
Research Site
Medellín, 050010
Research Site
Medellín, 050025
Hungary3 sites
Research Site
Budapest, 1085
Research Site
Budapest, 1097
Research Site
Debrecen, 4032
About this study
Official title: A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis
Read the detailed description
This Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study with OLE is to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The total study duration may be up to approximately 142 weeks, including screening and follow-up. Double-blind period will be 76 weeks. Participants who complete double-blind treatment period may enter open-label extension to receive anifrolumab for up 52 weeks. Approximately 360 of the enrolled participants will be randomly assigned to study intervention (anifrolumab or placebo) at a ratio of 1:1 during double-blind treatment period.
- Conditions
- Lupus Nephritis
- Being tested
- Anifrolumab, Placebo
- Keywords
- Lupus Nephritis, anifrolumab, Systemic Lupus Erythematosus, intravenous
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnifrolumabDrug
Also called Medi-546
Anifrolumab intravenous infusion (IV)
PlaceboDrug
Placebo intravenous infusion (IV)
| Study group | Role | What they receive |
|---|---|---|
| Anifrolumab | Experimental | Solution for intravenous infusion Receives: Drug: Anifrolumab |
| Placebo | Placebo comparator | Solution for intravenous infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group
CRR is defined as:
- UPCR ≤ 0.5 mg/mg
- eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20%
Measured: Week 52
Secondary outcomes (14)
Difference in proportion of participants achieving sustained OCS reduction in anifrolumab group compared with placebo group
Sustained OCS reduction
Measured: from Week 24 through Week 52
HR of achieving sustained CRR in anifrolumab compared with placebo group
The endpoint for deriving the summary measure is time to sustained CRR, defined as time to achieving CRR that is sustained from that time point through week 52
Measured: baseline through Week 52
Difference in the mean standardized AUC for UPCR between anifrolumab and placebo participants
Proteinuria as measured by the cumulative UPCR
Measured: baseline through Week 52
Difference in proportion of participants with CRR in anifrolumab group compared with placebo group
CRR at week 24
Measured: Week 24
HR to summarize the difference in the risk of hazard of renal-related event or death at any given time between anifrolumab and placebo participants
Onset of renal-related event or death through Week 52
Measured: Through Week 52
HR to summarize the difference in the risk of hazard of renal-related event or death at any given time between anifrolumab and placebo participants
Onset of renal-related event or death through Week 76
Measured: Through Week 76
Difference between anifrolumab and placebo in proportions of participants who achieve aCRR
aCRR (alternative complete renal response) defined as;
- UPCR ≤ 0.5 mg/mg
- eGFR ≥ 90 mL/min/1.73 m2 or no decrease from baseline of ≥ 10%
Measured: Week 52
Difference between anifrolumab and placebo in proportions of participants who achieve CRR with sustained OCS reduction
CRR at Week 52 with Sustained OCS Reduction
Measured: Week 52
HR of achieving sustained CRR in anifrolumab compared to placebo group
Time to sustained CRR through the time frame period
Measured: Through week 76
HR of achieving 50% reduction in UPCR in anifrolumab compared to placebo group
The endpoint for deriving the summary measure is time from the first dose of study intervention to achieving 50% reduction in UPCR
Measured: Through Week 52
Difference in mean UPCR between the anifrolumab and placebo group
Proteinuria as measured by UPCR
Measured: Week 52
Difference in proportion of participants achieving PRR (Partial Renal Response) in anifrolumab group compared with placebo group
PRR defined as:
UPCR <1.0 mg/mg (for participants with baseline UPCR ≤3 mg/mg) or >50% improvement and ≤3 mg/mg (for participants with baseline UPCR >3 mg/mg) eGFR
≥ 60 mL/min/1.73 m2 or no confirmed decrease of ≥20% from baseline
Measured: Week 52
Difference in change from baseline in extra-renal SLEDAI-2K total score
The extra-renal SLEDAI-2K score is obtained by summing the SLEDAI-2K items without including the items within the renal system organ
Measured: Through Week 76
Difference in mean change from baseline in domains and component scores of Short Form-36 Version 2 (SF-36v2) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) total score
To evaluate patient-reported HRQOL and health status
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start15 Feb 2022
- Primary completion23 Feb 2027 (estimated)
- Study completion4 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138133
- Sponsor's protocol ID
- D3466C00001
- Other IDs
- 2021-002862-42
- Acronym
- IRIS
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2021
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean that all requests will be shared.
Publications
Almquist J, Chia YL, Tummala R, Bertagnolli L, Jayne D, Tang W, Lindholm C. Anifrolumab Dose Regimen Selection for a Phase 3 Trial in Lupus Nephritis. Clin Pharmacol Ther. 2026 Aug;120(2):429-439. doi: 10.1002/cpt.70307. Epub 2026 May 22.
PubMed 42175562Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.
PubMed 37528520
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
- ClinicalTrials.gov ID
- NCT05138133
- Acronym / sponsor ID
- IRIS / D3466C00001
- Conditions
- Lupus Nephritis
- Keywords
- Lupus Nephritis, anifrolumab, Systemic Lupus Erythematosus, intravenous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 363 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 23 Feb 2027 (estimated)
- Study completion
- 4 Oct 2028 (estimated)
- First posted
- 30 Nov 2021 (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 purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis
Detailed description
This Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study with OLE is to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The total study duration may be up to approximately 142 weeks, including screening and follow-up. Double-blind period will be 76 weeks. Participants who complete double-blind treatment period may enter open-label extension to receive anifrolumab for up 52 weeks. Approximately 360 of the enrolled participants will be randomly assigned to study intervention (anifrolumab or placebo) at a ratio of 1:1 during double-blind treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anifrolumab | Experimental | Drug: AnifrolumabSolution for intravenous infusion |
| Placebo | Placebo comparator | Drug: PlaceboSolution for intravenous infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
- Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
- Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol)
- eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
- Fulfills updated 2019 EULAR/ACR SLE classification criteria.
Key exclusion criteria (8 listed)
- A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
- Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1).
- Evidence of hepatitis C or active hepatitis B.
- Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
- Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide > 2 pulses of high-dose (≥ 0.5 g/m2) or > 4 doses of low dose (500 mg every 2 weeks) or Average MMF > 2.5 g/day (or > 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus > 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF.
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 |
|---|---|---|
| AnifrolumabAlso: Medi-546Anifrolumab intravenous infusion (IV) | Drug | Anifrolumab |
| PlaceboPlacebo intravenous infusion (IV) | Drug | Placebo |
Primary outcome
Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group
Time frame: Week 52
CRR is defined as: * UPCR ≤ 0.5 mg/mg * eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20%
14 secondary outcomes
Difference in proportion of participants achieving sustained OCS reduction in anifrolumab group compared with placebo group
Time frame: from Week 24 through Week 52
HR of achieving sustained CRR in anifrolumab compared with placebo group
Time frame: baseline through Week 52
Difference in the mean standardized AUC for UPCR between anifrolumab and placebo participants
Time frame: baseline through Week 52
Difference in proportion of participants with CRR in anifrolumab group compared with placebo group
Time frame: Week 24
HR to summarize the difference in the risk of hazard of renal-related event or death at any given time between anifrolumab and placebo participants
Time frame: Through Week 52
HR to summarize the difference in the risk of hazard of renal-related event or death at any given time between anifrolumab and placebo participants
Time frame: Through Week 76
Difference between anifrolumab and placebo in proportions of participants who achieve aCRR
Time frame: Week 52
Difference between anifrolumab and placebo in proportions of participants who achieve CRR with sustained OCS reduction
Time frame: Week 52
HR of achieving sustained CRR in anifrolumab compared to placebo group
Time frame: Through week 76
HR of achieving 50% reduction in UPCR in anifrolumab compared to placebo group
Time frame: Through Week 52
Difference in mean UPCR between the anifrolumab and placebo group
Time frame: Week 52
Difference in proportion of participants achieving PRR (Partial Renal Response) in anifrolumab group compared with placebo group
Time frame: Week 52
Difference in change from baseline in extra-renal SLEDAI-2K total score
Time frame: Through Week 76
Difference in mean change from baseline in domains and component scores of Short Form-36 Version 2 (SF-36v2) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) total score
Time frame: Week 52
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 28 Oct 2026.
- Derived from this study: PubMed 42175562Almquist J, Chia YL, Tummala R, Bertagnolli L, Jayne D, Tang W, Lindholm C. Anifrolumab Dose Regimen Selection for a Phase 3 Trial in Lupus Nephritis. Clin Pharmacol Ther. 2026 Aug;120(2):429-439. doi: 10.1002/cpt.70307. Epub 2026 May 22.
- Derived from this study: PubMed 37528520Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean that all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
164 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anifrolumab in people with Lupus Nephritis, run by AstraZeneca at 164 sites in 24 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 6 inclusion and 8 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 164 sites in China, United States, Japan, Brazil, India and 19 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. Some participants in this study may receive a placebo. 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?
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?
Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group (time frame: Week 52). 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 NCT05138133, 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 28 Oct 2026.