Back to resultsPhase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis (IRIS)
Primary Purpose
Lupus Nephritis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Anifrolumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring Lupus Nephritis, anifrolumab, Systemic Lupus Erythematosus, intravenous
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Anifrolumab
Placebo
Arm Description
Solution for intravenous infusion
Solution for intravenous infusion
Outcomes
Primary Outcome Measures
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%
Secondary Outcome Measures
Difference in proportion of participants achieving sustained OCS reduction in anifrolumab group compared with placebo group.
Sustained OCS reduction
Hazard Ratio (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 the end of the time frame period.
Difference in the mean standardized AUC for UPCR between anifrolumab and placebo participants
Proteinuria as measured by the cumulative UPCR
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
The endpoint for deriving the summary measure is time to onset of renal-related event or death.
Time to onset of renal event as defined as any of the following:
ESKD,
doubling of serum creatinine,
renal worsening as evidenced by increased proteinuria and/or renal function impairment, or 4) renal disease treatment failure or death
Difference in proportion of participants achieving aCRR (Alternative Complete Renal Response)
aCRR is defined as:
UPCR ≤ 0.5 mg/mg;
eGFR ≥ 90 mL/min/1.73 m2 or no confirmed decrease of eGFR from baseline of ≥ 10%.
Difference in the proportion of participants achieving CRR with sustained OCS reduction
CRR with sustained OCS reduction
Difference in the proportion of participants achieving CRR
Early onset of CRR
HR of achieving sustained CRR in anifrolumab compared with placebo
Time to sustained CRR through the time frame period
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
Difference in mean UPCR between the anifrolumab and placebo group
Proteinuria as measured by UPCR
PRR (Partial Renal Response)
PRR defined as:
UPCR:
- For participants with a baseline UPCR ≤3 mg/mg: <1.0 mg/mgb eGFR:
≥ 60 mL/min/1.73 m2 or no confirmed decrease of eGFR from baseline of ≥ 20%
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05138133
Brief Title
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
Acronym
IRIS
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
July 7, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (consisting of 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 116 weeks, including the Screening and Follow-up. Approximately 360 participants will be randomized in a 1:1 ratio to receive anifrolumab or matching placebo throughout during the Treatment Period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
Lupus Nephritis, anifrolumab, Systemic Lupus Erythematosus, intravenous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind (Participant, Care Provider and Investigator)
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anifrolumab
Arm Type
Experimental
Arm Description
Solution for intravenous infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Solution for intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Anifrolumab
Other Intervention Name(s)
Medi-546
Intervention Description
Anifrolumab intravenous infusion (IV)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo intravenous infusion (IV)
Primary Outcome Measure Information:
Title
Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group
Description
CRR is defined as:
UPCR ≤ 0.5 mg/mg
eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20%
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Difference in proportion of participants achieving sustained OCS reduction in anifrolumab group compared with placebo group.
Description
Sustained OCS reduction
Time Frame
from Week 24 through Week 52
Title
Hazard Ratio (HR) of achieving sustained CRR in anifrolumab compared with placebo group
Description
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 the end of the time frame period.
Time Frame
baseline through Week 52
Title
Difference in the mean standardized AUC for UPCR between anifrolumab and placebo participants
Description
Proteinuria as measured by the cumulative UPCR
Time Frame
baseline through Week 52
Title
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
Description
The endpoint for deriving the summary measure is time to onset of renal-related event or death.
Time to onset of renal event as defined as any of the following:
ESKD,
doubling of serum creatinine,
renal worsening as evidenced by increased proteinuria and/or renal function impairment, or 4) renal disease treatment failure or death
Time Frame
baseline through Week 52, baseline through Week 104
Title
Difference in proportion of participants achieving aCRR (Alternative Complete Renal Response)
Description
aCRR is defined as:
UPCR ≤ 0.5 mg/mg;
eGFR ≥ 90 mL/min/1.73 m2 or no confirmed decrease of eGFR from baseline of ≥ 10%.
Time Frame
Week 52
Title
Difference in the proportion of participants achieving CRR with sustained OCS reduction
Description
CRR with sustained OCS reduction
Time Frame
Week 52
Title
Difference in the proportion of participants achieving CRR
Description
Early onset of CRR
Time Frame
Week 24
Title
HR of achieving sustained CRR in anifrolumab compared with placebo
Description
Time to sustained CRR through the time frame period
Time Frame
baseline through Week 104
Title
HR of achieving 50% reduction in UPCR in anifrolumab compared to placebo group
Description
The endpoint for deriving the summary measure is time from the first dose of study intervention to achieving 50% reduction in UPCR
Time Frame
baseline through Week 52
Title
Difference in mean UPCR between the anifrolumab and placebo group
Description
Proteinuria as measured by UPCR
Time Frame
Week 52
Title
PRR (Partial Renal Response)
Description
PRR defined as:
UPCR:
- For participants with a baseline UPCR ≤3 mg/mg: <1.0 mg/mgb eGFR:
≥ 60 mL/min/1.73 m2 or no confirmed decrease of eGFR from baseline of ≥ 20%
Time Frame
Week 52
Title
Difference in change from baseline in extra-renal SLEDAI-2K total score
Description
The extra-renal SLEDAI-2K score is obtained by summing the SLEDAI-2K items without including the items within the renal system organ.
Time Frame
baseline through Week 104
Title
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
Description
To evaluate patient-reported HRQOL and health status
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sun City Center
State/Province
Florida
ZIP/Postal Code
33573
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1425EOE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
X5004AUL
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2000PBJ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Miguel de Tucuman
ZIP/Postal Code
X4000AXL
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610072
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Haikou
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanning
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
201210
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Shengyang
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shenzhen
ZIP/Postal Code
518036
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300201
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuxi
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhengzhou City
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Aurillac Cedex
ZIP/Postal Code
15002
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75679
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
STRASBOURG Cedex
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kirchheim
ZIP/Postal Code
73230
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mainz Am Rhein
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ahmedabad
ZIP/Postal Code
380005
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ahmedabad
ZIP/Postal Code
382421
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dehradun
ZIP/Postal Code
248001
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gurugram
ZIP/Postal Code
122001
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nadiad
ZIP/Postal Code
387001
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110017
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110075
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Pune
ZIP/Postal Code
411001
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Secunderabad
ZIP/Postal Code
500003
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vijayawada
ZIP/Postal Code
522002
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Visakapatnam
ZIP/Postal Code
530013
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cona
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00152
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rome
ZIP/Postal Code
00166
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chiba-shi
ZIP/Postal Code
260-8712
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
810-8563
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gifu-shi
ZIP/Postal Code
500-8513
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Izumo-shi
ZIP/Postal Code
693-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kita-gun
ZIP/Postal Code
761-0793
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kitakyushu-shi
ZIP/Postal Code
807-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Matsumoto-shi
ZIP/Postal Code
390-8621
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagasaki-shi
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ono
ZIP/Postal Code
675-1392
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sagamihara-shi
ZIP/Postal Code
252-0375
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-0872
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shinagawa-ku
ZIP/Postal Code
142-0054
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toyoake-shi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44160
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44650
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
México
ZIP/Postal Code
06726
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Luis Potosi
ZIP/Postal Code
78290
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bellavista
ZIP/Postal Code
CALLAO 2
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15023
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15036
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15046
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 29
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Piura
ZIP/Postal Code
20001
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
86-605
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Opole
ZIP/Postal Code
46-020
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-355
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
61-545
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
51-124
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
92-213
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630090
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Orenburg
ZIP/Postal Code
460018
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
196066
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10220
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
6500
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34865
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35965
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kahramanmaras
ZIP/Postal Code
46100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ha Noi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Terminated
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hochiminh
ZIP/Postal Code
70000
Country
Vietnam
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
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