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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04564339




Registration number
NCT04564339
Ethics application status
Date submitted
21/09/2020
Date registered
25/09/2020
Date last updated
24/11/2023

Titles & IDs
Public title
Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
Scientific title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
Secondary ID [1] 0 0
2020-001537-13
Secondary ID [2] 0 0
ALXN1210-NEPH-202
Universal Trial Number (UTN)
Trial acronym
SANCTUARY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis 0 0
Immunoglobulin A Nephropathy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ravulizumab
Treatment: Drugs - Placebo
Other interventions - Background Therapy

Experimental: Ravulizumab: LN Cohort - Eligible participants will receive ravulizumab IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.

Placebo Comparator: Placebo: LN Cohort - Eligible participants will receive placebo IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.

Experimental: Ravulizumab: IgAN Cohort - Eligible participants will receive ravulizumab IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.

Placebo Comparator: Placebo: IgAN Cohort - Eligible participants will receive placebo IV infusion in combination with background therapy during the Initial Evaluation Period (26 weeks) and will switch to ravulizumab for the Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.


Treatment: Drugs: Ravulizumab
Dosages (loading and maintenance) will be based on the participant's body weight.

Treatment: Drugs: Placebo
Dosages (loading and maintenance) will be based on the participant's body weight.

Other interventions: Background Therapy
Participants will receive background therapy consistent with the standard of care.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 26 Assessed Using 24-hour Urine Collections
Timepoint [1] 0 0
Baseline, Week 26
Secondary outcome [1] 0 0
Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 50 Assessed Using 24-hour Urine Collections
Timepoint [1] 0 0
Baseline, Week 50
Secondary outcome [2] 0 0
Both Cohorts: Change In Estimated Glomerular Filtration Rate (eGFR) From Baseline At Week 26 And Week 50
Timepoint [2] 0 0
Baseline, Week 26, Week 50
Secondary outcome [3] 0 0
LN Cohort: Percentage Of Participants Meeting The Criteria For Complete Renal Response
Timepoint [3] 0 0
Week 26 and Week 50
Secondary outcome [4] 0 0
LN Cohort: Percentage Of Participants Meeting The Criteria For Partial Renal Response
Timepoint [4] 0 0
Week 26 and Week 50
Secondary outcome [5] 0 0
LN Cohort: Time To Urine Protein To Creatinine Ratio < 0.5 g/g
Timepoint [5] 0 0
Baseline through Week 50
Secondary outcome [6] 0 0
LN Cohort: Percentage Of Participants Achieving Corticosteroid Taper To 7.5 mg/day
Timepoint [6] 0 0
Week 14, Week 26, and Week 50
Secondary outcome [7] 0 0
LN Cohort: Percentage Of Participants With Renal Flare
Timepoint [7] 0 0
Baseline through Week 50
Secondary outcome [8] 0 0
LN Cohort: Percentage Of Participants With Extrarenal Systemic Lupus Erythematosus Flare
Timepoint [8] 0 0
Baseline through Week 50
Secondary outcome [9] 0 0
IgAN Cohort: Percentage Of Participants Meeting The Criteria For Partial Remission
Timepoint [9] 0 0
Week 26 and Week 50

Eligibility
Key inclusion criteria
Common to both disease cohorts:

- Proteinuria =1 (gram [g]/day or g/g)

- Vaccinated against meningococcal infection

- Vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae
according to national/local regulatory requirements

For LN cohort:

- Diagnosis of active focal or diffuse proliferative LN Class III or IV

- Clinically active LN, requiring/receiving immunosuppression induction treatment

For IgAN cohort:

- Diagnosis of primary IgAN

- Compliance with stable and optimal dose of renin-angiotensin system inhibitor
treatment for = 3 months
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Common to both disease cohorts:

- eGFR < 30 milliliters/minute/1.73 meters squared

- Previously received a complement inhibitor (for example, eculizumab)

- Concomitant significant renal disease other than LN or IgAN

- History of other solid organ or bone marrow transplant

- Uncontrolled hypertension

For IgAN cohort:

- Diagnosis of rapid progressive glomerulonephritis

- Prednisone or prednisone equivalent > 20 milligram (mg) per day for > 14 consecutive
days or any other immunosuppression within 6 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
MelbourneNSW,QLD
Recruitment hospital [1] 0 0
Clinical Study Site - Parkville
Recruitment hospital [2] 0 0
Clinical Study Site - Westmead
Recruitment hospital [3] 0 0
Clinical Study Site - Herston
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4006 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
France
State/province [15] 0 0
Bas-Rhin
Country [16] 0 0
France
State/province [16] 0 0
Clermont-Ferrand
Country [17] 0 0
France
State/province [17] 0 0
Créteil
Country [18] 0 0
France
State/province [18] 0 0
Le Kremlin-Bicêtre
Country [19] 0 0
France
State/province [19] 0 0
Montpellier
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
France
State/province [21] 0 0
Saint-Étienne
Country [22] 0 0
France
State/province [22] 0 0
Toulouse
Country [23] 0 0
Germany
State/province [23] 0 0
Niedersachsen
Country [24] 0 0
Germany
State/province [24] 0 0
North Rhine-Westphalia
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Essen
Country [27] 0 0
Germany
State/province [27] 0 0
Lubeck
Country [28] 0 0
Italy
State/province [28] 0 0
Bergamo
Country [29] 0 0
Italy
State/province [29] 0 0
Bologna
Country [30] 0 0
Italy
State/province [30] 0 0
Brescia
Country [31] 0 0
Italy
State/province [31] 0 0
Firenze
Country [32] 0 0
Italy
State/province [32] 0 0
Monza
Country [33] 0 0
Italy
State/province [33] 0 0
Torino
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Gyeonggi-do
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seoul
Country [36] 0 0
Netherlands
State/province [36] 0 0
Maastricht
Country [37] 0 0
Poland
State/province [37] 0 0
Bydgoszcz
Country [38] 0 0
Poland
State/province [38] 0 0
Lodz
Country [39] 0 0
Singapore
State/province [39] 0 0
Singapore
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Spain
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A Coruña
Country [41] 0 0
Spain
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Andalucia
Country [42] 0 0
Spain
State/province [42] 0 0
Comunidad
Country [43] 0 0
Spain
State/province [43] 0 0
Illes Balears
Country [44] 0 0
Spain
State/province [44] 0 0
Alicante
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona
Country [46] 0 0
Spain
State/province [46] 0 0
Lleida
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Spain
State/province [48] 0 0
Malaga
Country [49] 0 0
Spain
State/province [49] 0 0
Zaragoza
Country [50] 0 0
Sweden
State/province [50] 0 0
Orebro
Country [51] 0 0
Sweden
State/province [51] 0 0
Uppsala
Country [52] 0 0
Taiwan
State/province [52] 0 0
Kaohsiung City
Country [53] 0 0
Taiwan
State/province [53] 0 0
New Taipei City
Country [54] 0 0
Taiwan
State/province [54] 0 0
Taichung City
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Birmingham
Country [56] 0 0
United Kingdom
State/province [56] 0 0
London
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Nottingham
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objectives of this study are to evaluate the safety and efficacy of ravulizumab
administered by intravenous (IV) infusion compared to placebo and demonstrate
proof-of-concept of the efficacy of terminal complement inhibition in participants with LN
(LN Cohort) or IgAN (IgAN Cohort).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04564339
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alexion Pharmaceuticals, Inc.
Address 0 0
Country 0 0
Phone 0 0
855-752-2356
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04564339