Lupus NephritisPhase 2TULIP-LN1NCT02547922

Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis

A Phase 2 study testing Anifrolumab in people with Lupus Nephritis, run by AstraZeneca at 80 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN). 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: 147 participants
Where: 80 sitesin 17 countries
Study dates: 4 Nov 2015to 18 Jan 2021
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Main Inclusion Criteria:

Age 18 through 70 years at the time of screening
Fulfils at least 4 of the 11 criteria of the revised 1982 ACR classification criteria for SLE, at least one of which must be:
Positive antinuclear antibody (ANA) test (1:40 or higher) or
Elevated anti-dsDNA antibodies at screening (reported as equivocal or positive results), as per the centrallaboratory; or
Anti-Smith antibody at screening elevated to above normal (ie, positive or equivocal results) as per the central laboratory
Class III (±Class V) or Class IV (±Class V) LN according to the World Health Organisation (WHO) or 2003 ISN/RPS classification based on a renal biopsy obtained within 12 weeks prior to signing the ICF or during the screening period:
Urine protein to creatinine ratio >1 gm/gm (113.17 mg/mmol), obtained on a 24-hour urine collection at screening
Estimated glomerular filtration rate ≥35 mL/min/1.73 m2
Must not have active or latent TB on either chest radiograph or by Quantiferon gold test
Women of childbearing potential must have a negative serum beta-hCG test at screening and negative urine pregnancy test prior to the first dose of sponsor-provided MMF.

Main Exclusion Criteria:

Receipt of any investigational product (small molecule or biologic) or commercially available biologic agent within four weeks or 5 half lives prior to signing of the ICF, whichever is greater
Pure Class V membranous LN on a renal biopsy obtained within 12 weeks prior to signing ICF or during the screening period
Known intolerance to ≤1.0 gm/day of MMF
History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6 month period after enrolment
Subjects, who at the time of signing the ICF, received any of the following immunosuppressive therapies after their qualifying biopsy
Oral corticosteroids >0.5 mg/kg/day for more than 8 weeks or
Oral or IV pulse methylprednisolone >3.0 gm (cumulative dose) or
IV cyclophosphamide >2 pulses of high-dose (≥0.5 gm/m2) or >4 doses of low dose (500 mg every 2 weeks) or
Average MMF >2.5 gm/day (>1800 mg/day of enteric-coated mycophenolate sodium) for more than 8 weeks or
Tacrolimus >4 mg/day for more than 8 weeks
Major surgery within 8 weeks before signing the ICF or major surgery planned during the study period
History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF
Confirmed positive test for hepatitis B or hepatitis C
Any severe herpes infection at any time prior to randomization
Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years prior to randomization (vaginal, oral and skin candidiasis is not an exclusionreason).
History of cancer, apart from:
Squamous or basal cell carcinoma of the skin that has been successfully treated
Cervical cancer in situ that has been successfully treated
Concurrent enrolment in another clinical study with an IP within 4 weeks prior to ICF signing or within 5 half-lives of the IP used in that clinical study, whichever is longer.
During screening (within 30 days before Day 1 [Week 0 visit]), any of the following:
Aspartate transaminase (AST) >2.5×upper limit of normal (ULN)
Alanine transaminase (ALT) >2.5×ULN
Total bilirubin >ULN (unless due to Gilbert's syndrome [based on Investigator's judgement])
Glycosylated haemoglobin (HbA1c) >8% (or >0.08) at screening (diabetic subjects only)
Neutrophil count <1x103/μL (or <1.0 GI/L)
Platelet count <25x103/μL (or <25 GI/L)
Haemoglobin <8 g/dL (or <80 g/L).

Trial locations and contacts

80 sites in 17 countries.

Country

City, postcode or hospital

80 sites in 17 countries

United States17 sites

Research Site
Aurora, Colorado, 80045
Research Site
Boston, Massachusetts, 02118
Research Site
Columbus, Ohio, 43210
Research Site
DeBary, Florida, 32713
Research Site
Glendale, Arizona, 85306
Research Site
Great Neck, New York, 11021
Research Site
La Jolla, California, 92037-0706
Research Site
Los Angeles, California, 90095-1670
Research Site
Memphis, Tennessee, 38119
Research Site
New Hyde Park, New York, 11042
Research Site
New York, New York, 10016
Research Site
New York, New York, 10029
Research Site
Newark, New Jersey, 07103-2499
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Phoenix, Arizona, 85032
Research Site
The Bronx, New York, 10457
Research Site
Thousand Oaks, California, 91360

Other trials in United States

Peru9 sites

Research Site
Arequipa, AREQUIPA54
Research Site
Lima, L14
Research Site
Lima, L34
Research Site
Lima, LIMA 01
Research Site
Lima, LIMA 31
Research Site
Lima, LIMA 32
Research Site
Lima, LIMA 33
Research Site
Lima, Lima-1
Research Site
Lima

Other trials in Peru

Taiwan6 sites

Research Site
Changhua, 50006
Research Site
Kaohsiung City, 80756
Research Site
Taichung, 40447
Research Site
Taichung, 40705
Research Site
Taipei, 100
Research Site
Taoyuan City, 333

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France5 sites

Research Site
Bordeaux, 33076
Research Site
Marseille, 13005
Research Site
Paris, 75013
Research Site
Strasbourg, 67098
Research Site
Toulouse, 31059

Other trials in France

Mexico5 sites

Research Site
Chihuahua City, 31000
Research Site
Guadalajara, 44160
Research Site
Guadalajara, 44280
Research Site
México, 14080
Research Site
San Luis Potosí City, 78213

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Australia4 sites

Research Site
Adelaide, 5000
Research Site
Clayton, VIC 3168
Research Site
Parkville, 3050
Research Site
Westmead, 2145

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Belgium4 sites

Research Site
Brussels, 1070
Research Site
Brussels, 1200
Research Site
Leuven, 3000
Research Site
Liège, B-4000

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Hungary4 sites

Research Site
Budapest, 1097
Research Site
Debrecen, 4032
Research Site
Kaposvár, 7400
Research Site
Szeged, 6725

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Italy4 sites

Research Site
Milan, 20132
Research Site
Padova, 35128
Research Site
Pisa, 56126
Research Site
Reggio Emilia, 42100

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Serbia4 sites

Research Site
Belgrade, 11000
Research Site
Belgrade, 1100
Research Site
Niš, 18000
Research Site
Novi Sad, 21000

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South Korea4 sites

Research Site
Gwangju, 501-757
Research Site
Seoul, 05505
Research Site
Seoul, 150-713
Research Site
Suwon, 16499

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Argentina3 sites

Research Site
Buenos Aires, C1015ABO
Research Site
Córdoba, 5016
Research Site
Rosario, S2000PBJ

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Poland3 sites

Research Site
Krakow, 31-066
Research Site
Lodz, 92-213
Research Site
Warsaw, 02-637

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Russia3 sites

Research Site
Orenburg, 460018
Research Site
Saint Petersburg, 197022
Research Site
Saint Petersburg, 197089

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Germany2 sites

Research Site
Berlin, 10117
Research Site
Kiel, 24105

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Spain2 sites

Research Site
Barcelona, 08035
Research Site
Barcelona, 08036

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United Kingdom1 site

Research Site
London, E1 1BB

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About this study

Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Proliferative Lupus Nephritis

Read the detailed description

This is a Phase 2, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two intravenous (IV) treatment regimens of anifrolumab versus placebo while taking standard of care (SOC) treatment with mycophenolate mofetil (MMF) and corticosteroids in adult subjects with active proliferative lupus nephritis (LN).

Conditions: Lupus Nephritis
Being tested: Anifrolumab, Placebo
Keywords: lupus, nephritis, randomized, placebo, anifrolumab, safety, efficacy, adult
Medical subject headings: Lupus Nephritis, Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AnifrolumabBiological
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
PlaceboDrug
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112

Study groups in NCT02547922
Study group	Role	What they receive
Anifrolumab - Lower Dose	Experimental	Anifrolumab - Lower Dose Receives: Biological: Anifrolumab
Anifrolumab - Higher Dose	Experimental	Anifrolumab - Higher Dose Receives: Biological: Anifrolumab
Placebo	Placebo comparator	Placebo IV Q4W plus SOC Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR)
To evaluate the efficacy of anifrolumab plus SOC (combination of mycophenolate mofetil and corticosteroids) compared with placebo plus SOC in subjects with active proliferative lupus nephritis (LN).
Geometric mean ratio of 24-hour UPCR at week 52 over baseline. Values <1 indicate improvement from baseline.
Measured: From Week 1 (Baseline) up to Week 52

Secondary outcomes (1)

Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR)
CRR was defined as meeting all of the following:
- Estimated glomerular filtration rate (eGFR) is ≥60 mL/min/1.73 m^2 or no confirmed decrease of eGFR from baseline of ≥20%
- 24-hour UPCR ≤ 0.7 mg/mg
- No discontinuation of investigational product (IP) or use of restricted medication beyond the protocol allowed threshold before assessment
- eGFR was based on Modification of Diet in Renal Disease (MDRD) formula. Subjects treated with restricted medication beyond the protocol allowed threshold, or discontinuing study treatment for other reasons, were regarded as non-responders.
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 201518 Jan 2021

First posted14 Sep 2015 (estimated)
Study start4 Nov 2015
Primary completion26 Nov 2019
Study completion18 Jan 2021

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 (5)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02547922
Sponsor's protocol ID: D3461C00007
Acronym: TULIP-LN1
Status last verified: Oct 2021
First submitted: 31 Aug 2015
Last updated: 24 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
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:

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 42175562
Fava A, Petri M, Gavin PG, Csomor E, Brohawn PZ, Muthas D, Platt A, Lindholm C, Ferrari N. Anifrolumab Treatment Leads to Rapid Reduction in Urinary Biomarkers of Intrarenal Inflammation in Lupus Nephritis: Results From the Phase 2 Randomized Trial. Arthritis Rheumatol. 2026 Aug;78(8):1692-1699. doi: 10.1002/art.70089. Epub 2026 Mar 16.
PubMed 41663906
Brunner HI, Cody EM, Devarajan P, Huang B, Chen C, Sinibaldi D, Ramaswamy M, Knagenhjelm J, Jones F, Brohawn PZ, Tummala R, Lindholm C, White WI. The Renal Activity Index for Lupus Identifies Active Renal Disease and Treatment Response in Adult Patients With Systemic Lupus Erythematosus and Lupus Nephritis. Arthritis Care Res (Hoboken). 2026 Jun;78(6):723-732. doi: 10.1002/acr.25684. Epub 2026 Feb 23.
PubMed 41144892
Jayne D, Rovin B, Mysler E, Furie R, Houssiau F, Trasieva T, Knagenhjelm J, Schwetje E, Tang W, Tummala R, Lindholm C. Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. Lupus Sci Med. 2023 Aug;10(2):e000910. doi: 10.1136/lupus-2023-000910.
PubMed 37607780
Jayne D, Rovin B, Mysler EF, Furie RA, Houssiau FA, Trasieva T, Knagenhjelm J, Schwetje E, Chia YL, Tummala R, Lindholm C. Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis. Ann Rheum Dis. 2022 Apr;81(4):496-506. doi: 10.1136/annrheumdis-2021-221478. Epub 2022 Feb 10.
PubMed 35144924

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lupus Nephritis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Proliferative Lupus Nephritis
ClinicalTrials.gov ID: NCT02547922
Acronym / sponsor ID: TULIP-LN1 / D3461C00007
Conditions: Lupus Nephritis
Keywords: lupus, nephritis, randomized, placebo, anifrolumab, safety, efficacy, adult
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 147 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 4 Nov 2015 (actual)
Primary completion: 26 Nov 2019 (actual)
Study completion: 18 Jan 2021 (actual)
First posted: 14 Sep 2015 (estimated)
Results: Posted 24 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Anifrolumab - Lower Dose	Experimental	Biological: AnifrolumabAnifrolumab - Lower Dose
Anifrolumab - Higher Dose	Experimental	Biological: AnifrolumabAnifrolumab - Higher Dose
Placebo	Placebo comparator	Drug: PlaceboPlacebo IV Q4W plus SOC

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
AnifrolumabAdministration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112	Biological	Anifrolumab - Higher Dose, Anifrolumab - Lower Dose
PlaceboAdministration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112	Drug	Placebo

Primary outcome

Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR)
Time frame: From Week 1 (Baseline) up to Week 52
To evaluate the efficacy of anifrolumab plus SOC (combination of mycophenolate mofetil and corticosteroids) compared with placebo plus SOC in subjects with active proliferative lupus nephritis (LN). Geometric mean ratio of 24-hour UPCR at week 52 over baseline. Values <1 indicate improvement from baseline.

1 secondary outcome

Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR)
Time frame: Week 52

Results and safety

Results posted to the registry on 24 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anifrolumab - Basic Regimen	46	18
Anifrolumab - Intensified Regimen	52	28
Placebo	49	20

Primary outcome: Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR)

Time frame: From Week 1 (Baseline) up to Week 52. Geometric mean (95% Confidence Interval). Unit: milligram/milligram (mg/mg)

Measure	Anifrolumab - Basic Regimen n = 41	Anifrolumab - Intensified Regimen n = 50	All Anifrolumab n = 91	Placebo n = 41
Value	0.326 (0.190 to 0.561)	0.285 (0.177 to 0.457)	0.305 (0.198 to 0.468)	0.296 (0.175 to 0.499)

All Anifrolumab vs Placebo: Geometric Mean Ratio: 1.031 (95% CI 0.621 to 1.713), p = 0.9052, Mixed Models Analysis

Population analysed: Full analysis set (FAS): The FAS included all subjects who received at least one dose of study treatment and were analyzed according to randomized treatment (mITT principle). Here, overall number of subjects analyzed signifies the subjects with available data that were analyzed for the outcome measure.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From screening (Day-30 to -1) period until follow-up (Week 112).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anifrolumab - Basic Regimen- Treatment Period	10 of 45 (22.2%)	31 of 45 (68.9%)	0 of 45
Anifrolumab - Intensified Regimen- Treatment Period	9 of 51 (17.6%)	39 of 51 (76.5%)	0 of 51
All Anifrolumab- Treatment Period	19 of 96 (19.8%)	70 of 96 (72.9%)	0 of 96
Placebo- Treatment Period	8 of 49 (16.3%)	33 of 49 (67.3%)	0 of 49
Anifrolumab - Basic Regimen- Follow up	3 of 45 (6.7%)	0 of 45 (0%)	1 of 45
Anifrolumab - Intensified Regimen- Follow up	0 of 51 (0%)	0 of 51 (0%)	0 of 51
All Anifrolumab- Follow up	3 of 96 (3.1%)	0 of 96 (0%)	1 of 96
Placebo- Follow up	3 of 49 (6.1%)	0 of 49 (0%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 41663906Fava A, Petri M, Gavin PG, Csomor E, Brohawn PZ, Muthas D, Platt A, Lindholm C, Ferrari N. Anifrolumab Treatment Leads to Rapid Reduction in Urinary Biomarkers of Intrarenal Inflammation in Lupus Nephritis: Results From the Phase 2 Randomized Trial. Arthritis Rheumatol. 2026 Aug;78(8):1692-1699. doi: 10.1002/art.70089. Epub 2026 Mar 16.
Derived from this study: PubMed 41144892Brunner HI, Cody EM, Devarajan P, Huang B, Chen C, Sinibaldi D, Ramaswamy M, Knagenhjelm J, Jones F, Brohawn PZ, Tummala R, Lindholm C, White WI. The Renal Activity Index for Lupus Identifies Active Renal Disease and Treatment Response in Adult Patients With Systemic Lupus Erythematosus and Lupus Nephritis. Arthritis Care Res (Hoboken). 2026 Jun;78(6):723-732. doi: 10.1002/acr.25684. Epub 2026 Feb 23.
Derived from this study: PubMed 37607780Jayne D, Rovin B, Mysler E, Furie R, Houssiau F, Trasieva T, Knagenhjelm J, Schwetje E, Tang W, Tummala R, Lindholm C. Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. Lupus Sci Med. 2023 Aug;10(2):e000910. doi: 10.1136/lupus-2023-000910.
Derived from this study: PubMed 35144924Jayne D, Rovin B, Mysler EF, Furie RA, Houssiau FA, Trasieva T, Knagenhjelm J, Schwetje E, Chia YL, Tummala R, Lindholm C. Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis. Ann Rheum Dis. 2022 Apr;81(4):496-506. doi: 10.1136/annrheumdis-2021-221478. Epub 2022 Feb 10.
ProtocolLink provided by the sponsor.
SAPLink provided by the sponsor.
CSR SynopsisLink provided by the sponsor.
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:

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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.

AstraZeneca AB study director

AstraZeneca

80 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anifrolumab in people with Lupus Nephritis, run by AstraZeneca at 80 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Peru, Taiwan, France, Mexico and 12 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 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 24 Nov 2021). 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?

Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR) (time frame: From Week 1 (Baseline) up to 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 NCT02547922, which also lists 5 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 24 Nov 2021.