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VIBRANT: VIB4920 for Active Lupus Nephritis (VIBRANT)

Primary Purpose

Lupus Nephritis

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VIB4920
Placebo for VIB4920
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring Lupus Nephritis, Mycophenolate mofetil, VIB4920

Eligibility Criteria

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

Inclusion Criteria:

  1. Classification of Systemic Lupus Erythematosus (SLE) by any of the following criteria:

    1. the 1997 update of the 1982 American College of Rheumatology (ACR) criteria
    2. or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria
    3. or the 2019 European League Against Rheumatism (EULAR)/ACR criteria
  2. Urine protein-to-creatinine ratio (UPCR) >=1.5 based on a 24-hour urine collection at Visit -1 or within 14 days prior to Visit -1
  3. Renal biopsy documentation at Visit 1 of ISN/RPS LN with both of the following:

    1. Class III, Class IV, or Class V in combination with Class III or IV, and
    2. Modified NIH Activity Index >= 1

Exclusion Criteria:

  1. Inability or unwillingness to give written informed consent or comply with study protocol
  2. Contraindication to treatment with mycophenolate mofetil (MMF) or mycophenolate sodium; or treatment with MMF or mycophenolate sodium is inappropriate in the opinion of the investigator
  3. Treatment with a biologic agent or investigational agent within 90 days or 5 half-lives prior to Visit 0, whichever is longer
  4. Rituximab or other B cell depleting agent within 6 months prior to Visit 0
  5. Prior treatment with VIB4920
  6. Receipt of a live attenuated vaccine within 4 weeks prior to Visit 0
  7. Comorbidities requiring treatment with systemic corticosteroids, including those that have required 3 or more courses of systemic corticosteroids within 12 months prior to Visit 0
  8. Current malignancy or history of malignancy, except for adequately treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ >12 months prior to Visit 0
  9. End stage renal disease, defined as Estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m^2
  10. History of transplantation
  11. The following risks for thromboembolic events:

    1. Recent or recurrent deep venous thrombosis or arterial thromboembolism.
    2. Immobilization or major surgery within 12 weeks prior to Visit 0.
    3. History of congenital or inherited deficiency of antithrombin III, protein S, or protein C.
    4. History of anti-phospholipid syndrome.
    5. Any one of the following anti-phospholipid antibodies:

    i. Positive lupus anticoagulant test, or

    ii. Anti-beta2-glycoprotein I IgG ELISA titer >= 40 GPL, or

    iii. Anti-cardiolipin IgG ELISA titer >= 40 GPL

  12. History of a severe allergy or hypersensitivity reaction to any component of the VIB4920 formulation
  13. Any one of the following laboratory abnormalities:

    1. Peripheral B cell count < 5/mcl
    2. Neutropenia (absolute neutrophil count < 1000/mm^3)
    3. Anemia (hemoglobin < 8 g/dL)
    4. Thrombocytopenia (platelets < 50,000/mm^3)
    5. Aspartate aminotransferase or alanine aminotransferase >= 2x upper limit of normal
  14. Evidence of current or prior tuberculosis infection, including any of the following:

    1. Positive QuantiFERON-TB Gold or TB Gold Plus test
    2. Positive T-SPOT.TB test
    3. Positive purified protein derivation (PPD) tuberculin test, defined as > 5mm induration
  15. Human immunodeficiency virus (HIV) infection
  16. Current or past hepatitis B (HBV) infection
  17. Current or past hepatitis C virus (HCV) infection, except adequately treated HCV with documented sustained virologic response
  18. Active bacterial, viral, fungal, or opportunistic infection
  19. History of significant, recurrent, or chronic infection that may pose additional risks from participating in the study, in the opinion of the investigator
  20. History of severe psychiatric condition that would interfere with the participant's ability to comply with the study protocol, in the opinion of the investigator
  21. Current substance abuse, or history of substance abuse within 12 months of Visit 0
  22. Lack of peripheral venous access
  23. Pregnancy
  24. Breastfeeding
  25. Unwillingness to use a medically acceptable form of contraception for the duration of the study if female of child-bearing potential or if male with a partner of child- bearing potential
  26. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Sites / Locations

  • University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology
  • UCLA Medical Center: Division of Rheumatology
  • University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
  • University of Colorado School of Medicine: Division of Rheumatology
  • Yale University School of Medicine: Section of Rheumatology
  • University of Miami Miller School of Medicine: Nephrology & Hypertension Division
  • Emory University School of Medicine: Division of Rheumatology
  • University of Chicago, Department of Medicine: Rheumatology
  • University of Minnesota Medical School: Division of Renal Diseases and Hypertension
  • Washington University School of Medicine in St. Louis: Division of Nephrology
  • Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
  • Hospital for Special Surgery, New York: Division of Rheumatology
  • Columbia University Medical Center: Department of Medicine, Division of Rheumatology
  • Temple University, Lewis Katz School of Medicine, Department of Medicine: Nephrology
  • University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VIB4920

VIB4920 Placebo

Arm Description

Participants will receive VIB4920 1500 mg intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants will also receive methylprednisolone 1000 mg at Week 0 and will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to ≤ 5 mg per day from Week 8.

Participants will receive VIB4920 placebo intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants will also receive methylprednisolone 1000 mg at Week 0 and will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to ≤ 5 mg per day from Week 8.

Outcomes

Primary Outcome Measures

Proportion of participants who achieve a complete renal response
Complete renal response is defined as all of the following: Urine protein-to-creatinine ratio (UPCR) <= 0.5, based on a 24-hour urine collection Estimated glomerular filtration rate (eGFR) >= 120 ml/min/1.73 m^2 or, if < 120 ml/min/1.73 m^2, then > 80 percent of the eGFR at baseline Prednisone <= 5 mg/day from Week 8, according to the prednisone dosing restrictions

Secondary Outcome Measures

Proportion of participants who achieve a complete renal response
Complete renal response is defined as all of the following: Urine protein-to-creatinine ratio (UPCR) <= 0.5, based on a 24-hour urine collection Estimated glomerular filtration rate (eGFR) >= 120 ml/min/1.73 m^2 or, if < 120 ml/min/1.73 m^2, then > 80 percent of the eGFR at Week 0 Prednisone tapered to <= 5 mg/day by Week 8, and adherence to the prednisone dosing restrictions
Proportion of participants who achieve an overall renal response
Overall renal response is defined as all of the following: >= 50 percent improvement in the urine protein-to-creatinine ratio (UPCR) compared to baseline, based on a 24-hour urine collection Estimated glomerular filtration rate (eGFR) >= 120 ml/min/1.73 m^2, or if < 120 ml/min/1.73 m^2, then > 80 percent of the eGFR at baseline, and Prednisone <= 5 mg/day from Week 8, according to the prednisone dosing restrictions
Change in proportion of participants who have negative Anti-dsDNA antibodies post treatment initiation
The change in the proportion of participants who had a negative anti-dsDNA test after initiation of VIB4920 or placebo will be summarized by arm, and will be analyzed using an exact conditional logistic regression model
Change in proportion of participants with lower C3 levels after treatment initiation
The change in the proportion of participants who were hypocomplementemic for C3 after initiation of VIB4920 or placebo will be summarized by arm, and analyzed using an exact conditional logistic regression model with the binary response variable for the test result (C3)
Change in proportion of participants with lower C4 levels after treatment initiation
The change in the proportion of participants who were hypocomplementemic for C4 after initiation of VIB4920 or placebo will be summarized by arm, and analyzed using an exact conditional logistic regression model with the binary response variable for the test result (C4)
Proportion of participants who experience renal treatment failures
Renal treatment failure is defined as any one of the following: Worsening proteinuria, defined as both of the following: Urine protein-to-creatinine ratio (UPCR) > 1.0 >= 50 percent increase in UPCR compared to the lowest previous value Progressive deterioration in renal function, defined as both of the following: Serum creatinine >1.5 >= 50 percent increase in serum creatinine compared to the lowest previous value Nephritis that worsens or fails to sufficiently improve, according to the judgment of the investigator Receipt of a prohibited immunosuppressive medication, including but not limited to cyclophosphamide, azathioprine, solumedrol, rituximab, belimumab, and calcineurin inhibitors
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) post treatment
The change in SLEDAI-2K scores after initiation of VIB4920 or placebo will be summarized by arm, and analyzed using an analysis of covariance (ANCOVA) model with the SLEDAI-2K score at the timepoint as the dependent variable
Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index for Systemic Lupus Erythematosus (SLICC/ACR-DI) post treatment
The change in SLICC/ACR-DI scores after initiation of VIB4920 or placebo will be summarized by arm, and analyzed using an ANCOVA model with the SLICC/ACR-DI score at the time point as the dependent variable
Number of participants who experience at least one serious adverse event
The number of participants who experienced at least one SAE and the number of participants who experienced at least one AESI will be analyzed using a Fisher's exact test.
Number of participants who experience at least one adverse event of special interest
Adverse events of special interest include: Anaphylaxis Grade 3 or greater infusion reaction Grade 3 or greater hypersensitivity reaction Grade 3 or greater infection Thromboembolic event
Change in Serum IgM over study participation
Serum IgM levels will be analyzed using a longitudinal mixed effects model with the test results at the time points as the dependent variable
Changes in Serum IgG over study participation
Serum IgG levels will be analyzed using a longitudinal mixed effects model with the test results at the time points as the dependent variable
BLISS-LN primary efficacy renal response (PERR)
defined as all of the following: UPCR ≤ 0.7, and eGFR ≥ 60 ml/min/1.73m2, or if < 60 ml/min/1.73m2, then ≥ 80% of the eGFR at baseline, and no receipt of a prohibited immunosuppressive or immunomodulatory medication.
Urine Protein-to-Creatinine Ratio (UPCR)
Based on 24-hour urine collection

Full Information

First Posted
January 7, 2022
Last Updated
October 13, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT05201469
Brief Title
VIBRANT: VIB4920 for Active Lupus Nephritis
Acronym
VIBRANT
Official Title
A Phase 2a Randomized Placebo-Controlled Double-Blind Multicenter Trial of VIB4920 for Active Lupus Nephritis (ITN091AI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

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
This is a multi-center double-blind placebo controlled clinical trial evaluating the efficacy of VIB4920 combined with mycophenolate mofetil (MMF) and prednisone in achieving a renal response in participants with active lupus nephritis (LN).
Detailed Description
Seventy-four eligible participants with active lupus nephritis (LN) will be randomized to receive VIB4920 1500 mg or placebo intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants will also receive methylprednisolone 1000 mg at Week 0 and will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to ≤ 5 mg per day from Week 8. The primary endpoint will be assessed at Week 36, and participants followed until Week 60.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
Lupus Nephritis, Mycophenolate mofetil, VIB4920

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VIB4920
Arm Type
Experimental
Arm Description
Participants will receive VIB4920 1500 mg intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants will also receive methylprednisolone 1000 mg at Week 0 and will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to ≤ 5 mg per day from Week 8.
Arm Title
VIB4920 Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive VIB4920 placebo intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants will also receive methylprednisolone 1000 mg at Week 0 and will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to ≤ 5 mg per day from Week 8.
Intervention Type
Drug
Intervention Name(s)
VIB4920
Intervention Description
Participants will receive 1500 mg of VIB4920 at Weeks 0, 2, 4, 8, 12, 16, 20, and 24 while continuing on MMF and prednisone
Intervention Type
Drug
Intervention Name(s)
Placebo for VIB4920
Intervention Description
Participants will receive placebo for VIB4920 at Weeks 0, 2, 4, 8, 12, 16, 20, and 24 while continuing on MMF and prednisone
Primary Outcome Measure Information:
Title
Proportion of participants who achieve a complete renal response
Description
Complete renal response is defined as all of the following: Urine protein-to-creatinine ratio (UPCR) <= 0.5, based on a 24-hour urine collection Estimated glomerular filtration rate (eGFR) >= 120 ml/min/1.73 m^2 or, if < 120 ml/min/1.73 m^2, then > 80 percent of the eGFR at baseline Prednisone <= 5 mg/day from Week 8, according to the prednisone dosing restrictions
Time Frame
Week 36
Secondary Outcome Measure Information:
Title
Proportion of participants who achieve a complete renal response
Description
Complete renal response is defined as all of the following: Urine protein-to-creatinine ratio (UPCR) <= 0.5, based on a 24-hour urine collection Estimated glomerular filtration rate (eGFR) >= 120 ml/min/1.73 m^2 or, if < 120 ml/min/1.73 m^2, then > 80 percent of the eGFR at Week 0 Prednisone tapered to <= 5 mg/day by Week 8, and adherence to the prednisone dosing restrictions
Time Frame
Weeks 12, 24, 48, and 60
Title
Proportion of participants who achieve an overall renal response
Description
Overall renal response is defined as all of the following: >= 50 percent improvement in the urine protein-to-creatinine ratio (UPCR) compared to baseline, based on a 24-hour urine collection Estimated glomerular filtration rate (eGFR) >= 120 ml/min/1.73 m^2, or if < 120 ml/min/1.73 m^2, then > 80 percent of the eGFR at baseline, and Prednisone <= 5 mg/day from Week 8, according to the prednisone dosing restrictions
Time Frame
Weeks 12, 24, 36, 48 and 60
Title
Change in proportion of participants who have negative Anti-dsDNA antibodies post treatment initiation
Description
The change in the proportion of participants who had a negative anti-dsDNA test after initiation of VIB4920 or placebo will be summarized by arm, and will be analyzed using an exact conditional logistic regression model
Time Frame
12, 24, 36, 48, and 60
Title
Change in proportion of participants with lower C3 levels after treatment initiation
Description
The change in the proportion of participants who were hypocomplementemic for C3 after initiation of VIB4920 or placebo will be summarized by arm, and analyzed using an exact conditional logistic regression model with the binary response variable for the test result (C3)
Time Frame
Weeks 12, 24, 36, 48, and 60
Title
Change in proportion of participants with lower C4 levels after treatment initiation
Description
The change in the proportion of participants who were hypocomplementemic for C4 after initiation of VIB4920 or placebo will be summarized by arm, and analyzed using an exact conditional logistic regression model with the binary response variable for the test result (C4)
Time Frame
Weeks 12, 24, 36, 48, and 60
Title
Proportion of participants who experience renal treatment failures
Description
Renal treatment failure is defined as any one of the following: Worsening proteinuria, defined as both of the following: Urine protein-to-creatinine ratio (UPCR) > 1.0 >= 50 percent increase in UPCR compared to the lowest previous value Progressive deterioration in renal function, defined as both of the following: Serum creatinine >1.5 >= 50 percent increase in serum creatinine compared to the lowest previous value Nephritis that worsens or fails to sufficiently improve, according to the judgment of the investigator Receipt of a prohibited immunosuppressive medication, including but not limited to cyclophosphamide, azathioprine, solumedrol, rituximab, belimumab, and calcineurin inhibitors
Time Frame
Week 0 to Week 60
Title
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) post treatment
Description
The change in SLEDAI-2K scores after initiation of VIB4920 or placebo will be summarized by arm, and analyzed using an analysis of covariance (ANCOVA) model with the SLEDAI-2K score at the timepoint as the dependent variable
Time Frame
Weeks 12, 24, 36, 48, and 60
Title
Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index for Systemic Lupus Erythematosus (SLICC/ACR-DI) post treatment
Description
The change in SLICC/ACR-DI scores after initiation of VIB4920 or placebo will be summarized by arm, and analyzed using an ANCOVA model with the SLICC/ACR-DI score at the time point as the dependent variable
Time Frame
Weeks 24 and 60
Title
Number of participants who experience at least one serious adverse event
Description
The number of participants who experienced at least one SAE and the number of participants who experienced at least one AESI will be analyzed using a Fisher's exact test.
Time Frame
Week 0 to Week 60
Title
Number of participants who experience at least one adverse event of special interest
Description
Adverse events of special interest include: Anaphylaxis Grade 3 or greater infusion reaction Grade 3 or greater hypersensitivity reaction Grade 3 or greater infection Thromboembolic event
Time Frame
Week 0 to Week 60
Title
Change in Serum IgM over study participation
Description
Serum IgM levels will be analyzed using a longitudinal mixed effects model with the test results at the time points as the dependent variable
Time Frame
Weeks 12, 24, 36, 48, and 60
Title
Changes in Serum IgG over study participation
Description
Serum IgG levels will be analyzed using a longitudinal mixed effects model with the test results at the time points as the dependent variable
Time Frame
Weeks 12, 24, 36, 48, and 60
Title
BLISS-LN primary efficacy renal response (PERR)
Description
defined as all of the following: UPCR ≤ 0.7, and eGFR ≥ 60 ml/min/1.73m2, or if < 60 ml/min/1.73m2, then ≥ 80% of the eGFR at baseline, and no receipt of a prohibited immunosuppressive or immunomodulatory medication.
Time Frame
Weeks 12, 24, 36, 48, and 60
Title
Urine Protein-to-Creatinine Ratio (UPCR)
Description
Based on 24-hour urine collection
Time Frame
Weeks 12, 24, 36, 48, and 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals who meet all of the following criteria are eligible for enrollment as study participants: Age 18 years or older. Classification of Systemic Lupus Erythematosus (SLE) by any of the following criteria: the 1997 update of the 1982 American College of Rheumatology (ACR) criteria (1, 2), the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria (3), or the 2019 European League Against Rheumatism (EULAR)/ACR criteria (4). UPCR ≥ 1.0 based on a 24-hour urine collection at Visit -1. Renal biopsy within 24 weeks prior to Visit -1 of ISN/RPS LN (5, 6) with both of the following: Class III, Class IV, or Class V in combination with Class III or IV, and Modified NIH Activity Index ≥ 1. COVID-19 vaccination according to the current Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommendations (36). Exclusion Criteria: Individuals who meet any of these criteria are not eligible for enrollment as study participants: Inability or unwillingness to give written informed consent or comply with study protocol. Contraindication to treatment with MMF or mycophenolate sodium; or treatment with MMF or mycophenolate sodium is inappropriate in the opinion of the investigator. Treatment with a biologic agent, except belimumab, or investigational agent within 90 days or 5 half-lives prior to Visit 0, whichever is longer. Agents authorized by the FDA for prevention or treatment of COVID-19 are not considered investigational and are not exclusionary. Rituximab or other B cell depleting agent within 6 months prior to Visit 0. Prior treatment with VIB4920. Receipt of a live attenuated vaccine within 4 weeks prior to Visit 0. Comorbidities requiring treatment with systemic corticosteroids, including those that have required 3 or more courses of systemic corticosteroids within 12 months prior to Visit 0. Current malignancy or history of malignancy, except for adequately treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ > 12 months prior to Visit 0. End stage renal disease, defined as eGFR < 20 ml/min/1.73m2. History of transplantation. The following risks for thromboembolic events: Recent or recurrent deep venous thrombosis or arterial thromboembolism. Immobilization or major surgery within 12 weeks prior to Visit 0. History of congenital or inherited deficiency of antithrombin III, protein S, or protein C. History of anti-phospholipid syndrome, according to the 2006 Sapporo classification criteria (37). History of a severe allergy or hypersensitivity reaction to any component of the VIB4920 formulation. Any one of the following laboratory abnormalities: Peripheral B cell count < 5/μl. Neutropenia (absolute neutrophil count < 1000/mm3). Anemia (hemoglobin < 8 g/dL). Thrombocytopenia (platelets < 50,000/mm3). Aspartate aminiotransferase or alanine aminotransferase ≥ 2x upper limit of normal. Evidence of current or prior tuberculosis infection, including any of the following: Positive QuantiFERON-TB Gold or TB Gold Plus test. Positive T-SPOT.TB test. Positive purified protein derivation (PPD) tuberculin test, defined as > 5mm induration. Human immunodeficiency virus (HIV) infection. Current or past hepatitis B (HBV) infection. Current or past hepatitis C virus (HCV) infection, except adequately treated HCV with documented sustained virologic response. Active bacterial, viral, fungal, or opportunistic infection. History of significant, recurrent, or chronic infection that may pose additional risks from participating in the study, in the opinion of the investigator. History of severe psychiatric condition that would interfere with the participant's ability to comply with the study protocol, in the opinion of the investigator. Current substance abuse, or history of substance abuse within 12 months of Visit 0. Lack of peripheral venous access. Pregnancy. Breastfeeding. Unwillingness to use a medically acceptable form of contraception for the duration of the study if female of child-bearing potential or if male with a partner of childbearing potential. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Dall'Era, M.D.
Organizational Affiliation
University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Betty Diamond, M.D.
Organizational Affiliation
Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Wofsy, M.D.
Organizational Affiliation
University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of California San Diego School of Medicine: Division of Rheumatology, Allergy and Immunology
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCLA Medical Center: Division of Rheumatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado School of Medicine: Division of Rheumatology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School of Medicine: Section of Rheumatology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
University of Miami Miller School of Medicine: Nephrology & Hypertension Division
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University School of Medicine: Division of Rheumatology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30307
Country
United States
Facility Name
University of Chicago, Department of Medicine: Rheumatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Minnesota Medical School: Division of Renal Diseases and Hypertension
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Washington University School of Medicine in St. Louis: Division of Nephrology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Hospital for Special Surgery, New York: Division of Rheumatology
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center: Department of Medicine, Division of Rheumatology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Temple University, Lewis Katz School of Medicine, Department of Medicine: Nephrology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical mechanistic data from NIAID/DAIT-funded grants and contracts
IPD Sharing Time Frame
Within 24 months after database lock for the trial
IPD Sharing Access Criteria
Open Access
IPD Sharing URL
http://www.immport.org/home
Links:
URL
https://www.immunetolerance.org/
Description
Immune Tolerance Network (ITN)
URL
http://www.niaid.nih.gov/
Description
National Institute of Allergy and Infectious Diseases (NIAID)
URL
http://www.niaid.nih.gov/about/dait
Description
Division of Allergy, Immunology, and Transplantation (DAIT)

Learn more about this trial

VIBRANT: VIB4920 for Active Lupus Nephritis

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