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Lupus NephritisPhase 3BLISS-LNNCT01639339

Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

A Phase 3 study testing Belimumab 10 mg/kg plus standard therapy and Standard therapy in people with Lupus Nephritis, run by Human Genome Sciences Inc., a GSK Company at 118 sites in 21 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lupus Nephritis
What is being tested?
Belimumab 10 mg/kg plus standard therapy and Standard therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
448 participants
Where
118 sitesin 21 countries
Study dates
12 Jul 2012to 12 Mar 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
  • Biopsy confirmed active lupus nephritis.
  • Clinically active lupus renal disease at screening requiring /receiving induction therapy with Standard of Care medications.
  • Autoantibody-positive.

Who cannot join

  • Pregnant or nursing.
  • On dialysis within the past year.
  • Treatment with belimumab within the past year .
  • Receipt of induction therapy with cyclophosphamide within 3 months prior to induction therapy for the study.
  • Receipt of any B cell targeted therapy (for example, rituximab), investigational biological agent within the past year.
  • Severe active central nervous system (CNS) lupus.
Show all 10Show fewer
  • Required management of acute or chronic infections within the past 60 days.
  • Current drug or alcohol abuse or dependence.
  • Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  • History of severe allergic reaction to contrast agents or biological medicines.

Trial locations and contacts

118 sites in 21 countries.

118 sites in 21 countries

United States17 sites

  • GSK Investigational Site

    Bethlehem, Pennsylvania, 18017

  • GSK Investigational Site

    Brooklyn, New York, 11203

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599

  • GSK Investigational Site

    Charleston, South Carolina, 29425

  • GSK Investigational Site

    Columbus, Ohio, 43203

  • GSK Investigational Site

    Gainesville, Florida, 32610

  • GSK Investigational Site

    Great Neck, New York, 11021

  • GSK Investigational Site

    La Palma, California, 90623

  • GSK Investigational Site

    Manhasset, New York, 11030

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    Onalaska, Wisconsin, 54650

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    San Leandro, California, 94578

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Torrance, California, 90502

Other trials in United States

China15 sites

  • GSK Investigational Site

    Beijing, 100029

  • GSK Investigational Site

    Changsha, Hunan, 410008

  • GSK Investigational Site

    Chengdu, Sichuan, 610041

  • GSK Investigational Site

    Chongqing, 400038

  • GSK Investigational Site

    Fuzhou, 350005

  • GSK Investigational Site

    Guangzhou, 510080

  • GSK Investigational Site

    Nanchang, Jiangxi, 330006

  • GSK Investigational Site

    Nanning, 530021

  • GSK Investigational Site

    Shanghai, 200025

  • GSK Investigational Site

    Shanghai, 200040

  • GSK Investigational Site

    Shanghai, 200127

  • GSK Investigational Site

    Shenyang, Liaoning, 110004

  • GSK Investigational Site

    Shenzhen, 518035

  • GSK Investigational Site

    Wuhan, Hubei, 430030

  • GSK Investigational Site

    Xi'an

Other trials in China

South Korea11 sites

  • GSK Investigational Site

    Busan, 49201

  • GSK Investigational Site

    Daejeon, 301-721

  • GSK Investigational Site

    Daejeon, 35233

  • GSK Investigational Site

    Jeju Special Self-Governing Prov., 690-767

  • GSK Investigational Site

    Jeonju, 561-712

  • GSK Investigational Site

    Seoul, 04763

  • GSK Investigational Site

    Seoul, 06273

  • GSK Investigational Site

    Seoul, 06591

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Suwon, 16247

  • GSK Investigational Site

    Suwon-si, Gyeonggi-do, 16499

Other trials in South Korea

Germany10 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Göttingen, 37075

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Jena, Thuringia, 07740

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23538

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Brazil9 sites

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30150-320

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30150-221

  • GSK Investigational Site

    Goiânia, 74110-120

  • GSK Investigational Site

    Juiz de Fora, Minas Gerais, 36010-570

  • GSK Investigational Site

    Lajeado, 95900-000

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-903

  • GSK Investigational Site

    Salvador, 40050-410

  • GSK Investigational Site

    São José do Rio Preto, São Paulo, 15090-000

  • GSK Investigational Site

    São Paulo, São Paulo, 04039-901

Other trials in Brazil

France7 sites

  • GSK Investigational Site

    Cean Cedex 09, 14033

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Paris, 75013

  • GSK Investigational Site

    Strasbourg, 67091

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Argentina6 sites

  • GSK Investigational Site

    Buenos Aires, C1119ACN

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1425

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, C1015ABO

  • GSK Investigational Site

    Córdoba, 5000

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    San Miguel de Tucumán, Tucumán Province, CP 4000

Other trials in Argentina

Mexico5 sites

  • GSK Investigational Site

    Cuernavaca, Morelos, 62170

  • GSK Investigational Site

    Guadalajara, Jalisco, 45040

  • GSK Investigational Site

    México, 7760

  • GSK Investigational Site

    México, D.F., 14080

  • GSK Investigational Site

    Morelia, Michoacán, 58260

Other trials in Mexico

Philippines5 sites

  • GSK Investigational Site

    Cebu City, 6000

  • GSK Investigational Site

    Davao City, 8000

  • GSK Investigational Site

    Iloilo City, 5000

  • GSK Investigational Site

    Lipa City, Batangas, 4217

  • GSK Investigational Site

    Manila, 1000

Other trials in Philippines

Spain5 sites

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 8035

  • GSK Investigational Site

    Palma de Mallorca, 07010

  • GSK Investigational Site

    Valencia, 46017

  • GSK Investigational Site

    Vigo/ Pontevedra, 36200

Other trials in Spain

Russia4 sites

  • GSK Investigational Site

    Moscow, 125284

  • GSK Investigational Site

    Orenburg, 460000

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Ufa, 450005

Other trials in Russia

Thailand4 sites

  • GSK Investigational Site

    Khon Kaen, 40002

  • GSK Investigational Site

    Muang, 50200

  • GSK Investigational Site

    Rajathevee, 10400

  • GSK Investigational Site

    Saimai, 10220

Other trials in Thailand

Belgium3 sites

  • GSK Investigational Site

    Brussels, 1090

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Leuven, 3000

Other trials in Belgium

Czechia3 sites

  • GSK Investigational Site

    Olomouc, 775 20

  • GSK Investigational Site

    Prague, 128 08

  • GSK Investigational Site

    Prague, 128 50

Other trials in Czechia

Netherlands3 sites

  • GSK Investigational Site

    Groningen, 9728 NT

  • GSK Investigational Site

    Leiden, 2333 ZA

  • GSK Investigational Site

    Maastricht, 6229 HX

Other trials in Netherlands

Taiwan3 sites

  • GSK Investigational Site

    Gueishan Township,Taoyuan County, 333

  • GSK Investigational Site

    Kaohsiung City, 83301

  • GSK Investigational Site

    Taichung, 40705

Other trials in Taiwan

Canada2 sites

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2B7

  • GSK Investigational Site

    Montreal, Quebec, H3G 1A4

Other trials in Canada

Hungary2 sites

  • GSK Investigational Site

    Miskolc, 3526

  • GSK Investigational Site

    Szeged, 6725

Other trials in Hungary

United Kingdom2 sites

  • GSK Investigational Site

    London, E1 1BB

  • GSK Investigational Site

    London, SE1 7EH

Other trials in United Kingdom

Colombia1 site

  • GSK Investigational Site

    Bogotá

Other trials in Colombia

Hong Kong1 site

  • GSK Investigational Site

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab Plus Standard of Care Versus Placebo Plus Standard of Care in Adult Subjects With Active Lupus Nephritis

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.

Read the detailed description

Study participants receive standard therapy (induction and maintenance) for lupus nephritis in addition to receiving either placebo (no active medicine) or belimumab. Induction therapy starts before the first dose of study drug (belimumab or placebo). Maintenance therapy begins after completion of induction therapy and continues for the remainder of the study. Participants receive study drug throughout the entire study, during both induction and maintenance periods. The controlled period of the study is 104 weeks. The random assignment in this study is "1 to 1" which means you have an equal chance of receiving treatment with belimumab or placebo. Participants who successfully complete the 104-week study may enter into a 6-month open-label extension. All participants in the open-label extension receive belimumab.

Conditions
Lupus Nephritis
Being tested
Placebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, Standard therapy
Keywords
Antibodies, Systemic Lupus Erythematosus, Autoimmune Disease, Glomerulonephritis, Belimumab, Lupus, Nephritis, Kidney Diseases, SLE
Medical subject headings
Lupus Nephritis, Lupus Erythematosus, Systemic, Autoimmune Diseases, Glomerulonephritis, Nephritis, Kidney Diseases

What participants receive

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

  • Placebo plus standard therapyBiological

    Placebo plus standard therapy

  • Belimumab 10 mg/kg plus standard therapyBiological

    Also called BENLYSTA™

    Belimumab 10 mg/kg plus standard therapy

  • Standard therapyDrug

    The standard therapies allowed in this study are:

    • High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy

    OR

    • High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy
Study groups in NCT01639339
Study groupRoleWhat they receive
Placebo plus standard therapyPlacebo comparatorPlacebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, placebo patients who opt to participate will receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.
Receives: Biological: Placebo plus standard therapy; Drug: Standard therapy
Belimumab 10 mg/kg plus standard therapyExperimentalBelimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, patients who opt to participate will continue to receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.
Receives: Biological: Belimumab 10 mg/kg plus standard therapy; Drug: Standard therapy

What is being measured

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

  1. Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104

    PERR is defined as urinary protein creatinine ratio <=0.7, estimated glomerular filtration rate (eGRF) was not more than 20 percent (%) below the pre-flare value or >=60 milliliters per minute per 1.73 square meter (mL/min/1.73m^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates treatment group, induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinine ratio (uPCR), and Baseline eGFR. Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received at least one dose of study treatment and were not excluded due to Good Clinical Practice (GCP) non-compliance. Percentage of participants with PERR at Week 104 has been presented.

    Measured: Week 104

  2. Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.

    Measured: From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)

  3. Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI)

    An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections [OI], Herpes Zoster [HZ], tuberculosis [TB], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths.

    Measured: From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)

Secondary outcomes (6)

  1. Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104

    CRR is defined as urinary protein creatinine ratio <0.5, eGRF was not more than 10% below the pre-flare value or >=90 mL/min/1.73m^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline uPCR and Baseline eGFR. Percentage of participants with CRR at Week 104 has been presented.

    Measured: Week 104

  2. Double-blind Period: Percentage of Participants With PERR at Week 52

    PERR is defined as urinary protein creatinine ratio <=0.7, eGRF was not more than 20% below the pre-flare value or >=60 mL/min/1.73m^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), uPCR, and Baseline eGFR. Percentage of participants with PERR at Week 52 has been presented.

    Measured: Week 52

  3. Double-blind Period: Number of Participants With Time to Death or Renal Related Event

    Events are defined as the first event experienced among the following: death, progression to end stage renal disease, doubling of serum creatinine from Baseline, renal worsening or renal-related treatment failure. Participants who discontinued randomized treatment, withdrew from the study, were lost to follow-up, or had a non renal-related treatment failure were censored. Participants who completed the 104-week treatment period were censored at the Week 104 visit. Time to event is defined as event date minus treatment start date plus one. Analysis was performed using Cox proportional hazards model for the comparison between Belimumab and Placebo adjusting for induction regimen, race, Baseline uPCR and Baseline eGFR. Number of participants with time to death or renal related event up to Week 104 has been presented.

    Measured: Up to Week 104

  4. Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104

    ORR is defined with respect to reproducible responses that included CRR, partial RR (PRR) and non responder. CRR is reported when uPCR was <0.5, eGFR was not more than 10% below pre-flare GFR or within normal range and not a treatment failure. PRR is >=50% decrease from Baseline in uPCR and one of the following: value <1 if Baseline <=3, or value <3 if the Baseline was >3, eGFR not more than 10% below Baseline GFR or within normal range and not a treatment failure and not a CRR. Non responder is reported when neither CRR nor PRR criteria was met. Percentage of participants reporting CRR, PRR and non responders at Week 104 has been presented.

    Measured: Week 104

  5. Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs

    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs has been reported.

    Measured: Up to Week 104

  6. Double-blind Period: Number of Participants Reporting AESI

    An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections [OI], Herpes Zoster [HZ], tuberculosis [TB], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths. On-treatment data is displayed.

    Measured: Up to Week 104

Timeline

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

  1. First posted12 Jul 2012 (estimated)
  2. Study start12 Jul 2012
  3. Primary completion25 Jul 2019
  4. Study completion12 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
448 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01639339
Sponsor's protocol ID
114054
Other IDs
2011-004570-28
Acronym
BLISS-LN
Status last verified
Feb 2021
First submitted
10 Jul 2012
Last updated
19 Mar 2021
Data monitoring committee
Yes
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Furie R, Anders HJ, Bertsias G, Delgado A, Levy RA, Curtis P, O'Shea C, Tomlinson R, Rovin B. A post hoc analysis of BLISS-LN found Belimumab plus mycophenolate mofetil improves kidney outcomes versus placebo plus mycophenolate mofetil in active lupus nephritis. Kidney Int. 2026 Aug;110(2):451-462. doi: 10.1016/j.kint.2026.03.030. Epub 2026 May 21.

    PubMed 42173278

  • Anders HJ, Furie R, Malvar A, Zhao MH, Hiromura K, Weinmann-Menke J, Green Y, Jones-Leone A, Negrini D, Levy RA, Lightstone L, Tanaka Y, Rovin BH. Effect of belimumab on kidney-related outcomes in patients with lupus nephritis: post hoc subgroup analyses of the phase 3 BLISS-LN trial. Nephrol Dial Transplant. 2023 Nov 30;38(12):2733-2742. doi: 10.1093/ndt/gfad167.

    PubMed 37463054

  • Sada K, Kurita N, Noma H, Matsuki T, Quasny H, Levy RA, Jones-Leone AR, Gairy K, Yajima N. MOONLIGHT study: the design of a comparative study of the effectiveness of belimumab in patients with a history of lupus nephritis from the post-Marketed effectiveness of belimumab cOhOrt and JapaN Lupus NatIonwide reGistry (LUNA) coHorT. Lupus Sci Med. 2022 Sep;9(1):e000746. doi: 10.1136/lupus-2022-000746.

    PubMed 37017254

  • Furie R, Rovin BH, Houssiau F, Contreras G, Teng YKO, Curtis P, Green Y, Okily M, Madan A, Roth DA. Safety and Efficacy of Belimumab in Patients with Lupus Nephritis: Open-Label Extension of BLISS-LN Study. Clin J Am Soc Nephrol. 2022 Nov;17(11):1620-1630. doi: 10.2215/CJN.02520322. Epub 2022 Oct 27.

    PubMed 36302567

  • Yu X, Chen N, Xue J, Mok CC, Bae SC, Peng X, Chen W, Ren H, Li X, Noppakun K, Gilbride JA, Green Y, Ji B, Liu C, Madan A, Okily M, Tang CH, Roth DA. Efficacy and Safety of Belimumab in Patients With Lupus Nephritis: Subgroup Analyses of a Phase 3 Randomized Trial in the East Asian Population. Am J Kidney Dis. 2023 Mar;81(3):294-306.e1. doi: 10.1053/j.ajkd.2022.06.013. Epub 2022 Sep 2.

    PubMed 36058429

  • Rovin BH, Furie R, Teng YKO, Contreras G, Malvar A, Yu X, Ji B, Green Y, Gonzalez-Rivera T, Bass D, Gilbride J, Tang CH, Roth DA. A secondary analysis of the Belimumab International Study in Lupus Nephritis trial examined effects of belimumab on kidney outcomes and preservation of kidney function in patients with lupus nephritis. Kidney Int. 2022 Feb;101(2):403-413. doi: 10.1016/j.kint.2021.08.027. Epub 2021 Sep 22.

    PubMed 34560137

  • Furie R, Rovin BH, Houssiau F, Malvar A, Teng YKO, Contreras G, Amoura Z, Yu X, Mok CC, Santiago MB, Saxena A, Green Y, Ji B, Kleoudis C, Burriss SW, Barnett C, Roth DA. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. N Engl J Med. 2020 Sep 17;383(12):1117-1128. doi: 10.1056/NEJMoa2001180.

    PubMed 32937045

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Belimumab 10 mg/kg plus standard therapy and Standard therapy in people with Lupus Nephritis, run by Human Genome Sciences Inc., a GSK Company at 118 sites in 21 countries.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, China, South Korea, Germany, Brazil and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104 (time frame: Week 104). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01639339, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.

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