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Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) (SANCTUARY)

Primary Purpose

Lupus Nephritis, Immunoglobulin A Nephropathy

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ravulizumab
Placebo
Background Therapy
Sponsored by
Alexion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring glomerulonephritis, IGA, lupus nephritis, complement C5

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Ravulizumab: LN Cohort

Placebo: LN Cohort

Ravulizumab: IgAN Cohort

Placebo: IgAN Cohort

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 26 Assessed Using 24-hour Urine Collections

Secondary Outcome Measures

Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 50 Assessed Using 24-hour Urine Collections
Both Cohorts: Change In Estimated Glomerular Filtration Rate (eGFR) From Baseline At Week 26 And Week 50
LN Cohort: Percentage Of Participants Meeting The Criteria For Complete Renal Response
Complete renal response will be determined by assessing proteinuria on 24-hour urine collections, eGFR levels, and no treatment failure.
LN Cohort: Percentage Of Participants Meeting The Criteria For Partial Renal Response
Partial renal response will be determined by assessing proteinuria on 24-hour urine collections, eGFR levels, and no treatment failure.
LN Cohort: Time To Urine Protein To Creatinine Ratio < 0.5 g/g
LN Cohort: Percentage Of Participants Achieving Corticosteroid Taper To 7.5 mg/day
LN Cohort: Percentage Of Participants With Renal Flare
LN Cohort: Percentage Of Participants With Extrarenal Systemic Lupus Erythematosus Flare
IgAN Cohort: Percentage Of Participants Meeting The Criteria For Partial Remission
Partial remission will be determined by assessing proteinuria on 24-hour urine collections.

Full Information

First Posted
September 21, 2020
Last Updated
March 21, 2023
Sponsor
Alexion
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1. Study Identification

Unique Protocol Identification Number
NCT04564339
Brief Title
Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
Acronym
SANCTUARY
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
This study consists of a 6-week Screening Period, 26-week Initial Evaluation Period, a 24-week Extension Period, and a 36-week post-treatment Follow-up Period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis, Immunoglobulin A Nephropathy
Keywords
glomerulonephritis, IGA, lupus nephritis, complement C5

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants, all investigative site personnel, and any Alexion employee, or designee, directly associated with the conduct of the study will be blinded to participant treatment assignments during the 26-week Initial Evaluation Period. Both the participants and the investigative site personnel will remain blinded for the remaining 24-week Extension Period.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ravulizumab: LN Cohort
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo: LN Cohort
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Ravulizumab: IgAN Cohort
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo: IgAN Cohort
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ravulizumab
Other Intervention Name(s)
Ultomiris
Intervention Description
Dosages (loading and maintenance) will be based on the participant's body weight.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosages (loading and maintenance) will be based on the participant's body weight.
Intervention Type
Other
Intervention Name(s)
Background Therapy
Intervention Description
Participants will receive background therapy consistent with the standard of care.
Primary Outcome Measure Information:
Title
Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 26 Assessed Using 24-hour Urine Collections
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 50 Assessed Using 24-hour Urine Collections
Time Frame
Baseline, Week 50
Title
Both Cohorts: Change In Estimated Glomerular Filtration Rate (eGFR) From Baseline At Week 26 And Week 50
Time Frame
Baseline, Week 26, Week 50
Title
LN Cohort: Percentage Of Participants Meeting The Criteria For Complete Renal Response
Description
Complete renal response will be determined by assessing proteinuria on 24-hour urine collections, eGFR levels, and no treatment failure.
Time Frame
Week 26 and Week 50
Title
LN Cohort: Percentage Of Participants Meeting The Criteria For Partial Renal Response
Description
Partial renal response will be determined by assessing proteinuria on 24-hour urine collections, eGFR levels, and no treatment failure.
Time Frame
Week 26 and Week 50
Title
LN Cohort: Time To Urine Protein To Creatinine Ratio < 0.5 g/g
Time Frame
Baseline through Week 50
Title
LN Cohort: Percentage Of Participants Achieving Corticosteroid Taper To 7.5 mg/day
Time Frame
Week 14, Week 26, and Week 50
Title
LN Cohort: Percentage Of Participants With Renal Flare
Time Frame
Baseline through Week 50
Title
LN Cohort: Percentage Of Participants With Extrarenal Systemic Lupus Erythematosus Flare
Time Frame
Baseline through Week 50
Title
IgAN Cohort: Percentage Of Participants Meeting The Criteria For Partial Remission
Description
Partial remission will be determined by assessing proteinuria on 24-hour urine collections.
Time Frame
Week 26 and Week 50

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexion Pharmaceuticals, Inc.
Phone
855-752-2356
Email
clinicaltrials@alexion.com
Facility Information:
Facility Name
Clinical Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
S. Gate
State/Province
California
ZIP/Postal Code
90280
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Study Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32835
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7155
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84115
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53213
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Parkville
State/Province
Melbourne
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Quebec
ZIP/Postal Code
G1R2J6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Essen
State/Province
North Rhine-Westphalia
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Lubeck
ZIP/Postal Code
23562
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Clinical Study Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Torino
ZIP/Postal Code
10154
Country
Italy
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Anyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
14068
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Clinical Study Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Clinical Study Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Clinical Study Site
City
Maastricht
ZIP/Postal Code
6229
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Bydgoszcz
ZIP/Postal Code
85-605
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Clinical Study Site
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Santiago De Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Clinical Study Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Valencia
State/Province
Comunidad
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Palma
State/Province
Illes Balears
ZIP/Postal Code
17120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Orebro
ZIP/Postal Code
70185
Country
Sweden
Individual Site Status
Withdrawn
Facility Name
Clinical Study Site
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Kaohsiung City
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Taichung City
ZIP/Postal Code
404332
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Clinical Study Site
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

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