Lupus NephritisPhase 2NCT02770170
Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
A Phase 2 study testing BI 655064 dose 1, BI 655064 dose 2 and BI 655064 dose 3 in people with Lupus Nephritis, run by Boehringer Ingelheim at 74 sites in 20 countries.
Trial summary
The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- BI 655064 dose 1, BI 655064 dose 2 and BI 655064 dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 74 sitesin 20 countries
- Study dates
- 16 May 2016to 18 Aug 2020
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 18-70 years. Women of childbearing potential must be ready and able (as assessed by investigator) to use simultaneously two reliable methods of birth control, one of which must be highly effective. Highly effective method, per ICH M3(R2) is a method that result in a low failure rate of less than 1% per year when used consistently and correctly.
- Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology (ACR) criteria 1997, at least 4 criteria must be documented, one of which must be a positive anti-dsDNA antibody OR a positive antinuclear antibody (ANA) at screening or around time of start of induction therapy
- Lupus Nephritis Class III or IV (International Society of Nephrology (ISN)/Renal Pathology Society (RPS) -2003 classification) with either active or active/chronic disease, co-existing class V permitted, proven by renal biopsy within 3 months prior to screening or during screening if induction therapy has not yet been started
- Active renal disease evidenced by proteinuria ≥ 1.0 g/day [(Uprot/Ucrea) ≥ 1]
- Signed and dated written informed consent
Who cannot join
- Clinically significant current other renal disease
- Glomerular Filtration Rate <30ml/min/1.73m²
- Dialysis within 12m of screening
- Antiphospholipid syndrome
- Diabetes mellitus poorly controlled or known diabetic retinopathy or nephropathy
- Evidence of current or previous clinically significant disease, medical condition or finding in the medical examination that in the investigator's opinion would compromise the safety of the patient or the quality of the data
Show all 21Show fewer
- Any induction therapy for Lupus Nephritis within the last 6 months prior to randomisation except induction with Mycophenolate Mofetil and high dose steroids started within 6 weeks prior to randomisation
- Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20, anti-CD22,) within 12 months prior to randomisation
- Treatment with abatacept within 12 months prior to randomisation
- Treatment with tacrolimus or cyclosporin within 4 weeks prior to randomisation
- Treatment with cyclophosphamid within 6 months prior to randomisation
- Treatment with investigational drug within 6 months or 5 half-lives, whichever is greater before randomisation
- Contraindication for MMF or corticosteroids and/or known hypersensitivity to any constituents of the study drug.
- Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical tuberculosis (TB) and/or a positive QuantiFERON TB-Gold test
- Any active or suspected malignancy or history of documented malignancy within the last 5 years before screening, except appropriately treated carcinoma in situ and treated basal cell carcinoma.
- Live vaccination within 6 weeks before randomisation
- Patients unable to comply with the protocol in the investigator's opinion.
- Alcohol abuse in the opinion of the investigator or active drug abuse .
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Impaired hepatic function, defined as serum Aspartate Transferase/Alanine Transferase, bilirubin or alkaline phosphatase levels > 2 x Upper Limit of Normal
- Further exclusion criteria apply.
Trial locations and contacts
74 sites in 20 countries.
74 sites in 20 countries
United States9 sites
Emory University
Atlanta, Georgia, 30322
Integrity Clinical Research, LLC
Doral, Florida, 33166
Northwell Health
Great Neck, New York, 11021
Hope Clinical Research
Kissimmee, Florida, 34741
Academic Medical Research Institute
Los Angeles, California, 90022
Feinstein Institute for Medical Research
Manhasset, New York, 11030
Office of Dr. Ramesh C. Gupta
Memphis, Tennessee, 38119
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032
Integral Rheumatology and Immunology Specialist
Plantation, Florida, 33324
Japan7 sites
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
St. Marianna University School of Medicine Hospital
Kanagawa, Kawasaki, 216-8511
Tohoku University Hospital
Miyagi, Sendai, 980-8574
Okayama University Hospital
Okayama, Okayama, 700-8558
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582
Germany6 sites
Universitätsklinikum Köln (AöR)
Cologne, 50937
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075
Asklepios Klinik Altona
Hamburg, 22763
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Robert-Bosch-Krankenhaus GmbH
Stuttgart, 70376
Poland6 sites
University Clinical Hospital in Bialystok I
Bialystok, 15-540
Norbert Barlicki University Clinical Hospital No.1, Lodz
Lodz, 90-153
Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard
Lodz, 92-213
Clinic Medical Center; Nowa Sol
Nowa Sól, 67-100
NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom
Radom, 26610
John Paul II Regional Hospital, Zamosc
Zamość, 22-400
Philippines5 sites
Angeles University Foundation Medical Center
Angeles City, 2009
Chong Hua Hospital
Cebu City, 6000
Cebu Doctors Hospital
Cebu City, Cebu, 6000
Southern Philippines Medical Center
Davao City, 8000
Mary Mediatrix Medical Center
Lipa City, Batangas, 4217
Thailand5 sites
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Pramongkutklao Hospital
Bangkok, 10400
Siriraj Hospital
Bangkok, 10700
Chiangmai University
Chiang Mai, 50200
Naresuan University Hospital
Muang, 65000
Mexico4 sites
Hospital Cardiologica Aguascalientes
Aguascalientes, 20230
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, 14080
Instituto Nacional de Cs Médicas y Nutrición S Zubiran
Mexico City, 14080
H. Central Dr Ignacio M. P.
San Luis Potosí City, 78240
Portugal4 sites
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3000-075
Hospital Curry Cabral, EPE
Lisbon, 1069-166
CHULN, EPE - Hospital de Santa Maria
Lisbon, 1649-035
Centro Hospitalar Universitário São João,EPE
Porto, 4200-319
Spain4 sites
Hospital Vall d'Hebron
Barcelona, 08035
Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Dr. Peset
Valencia, 46017
Czechia3 sites
Hospital Hradec Kralove
Hradec Králové, 50005
General University Hospital Prague 2, Nephrology Clinic
Prague, 12808
Institute of Rheumathology Prague
Prague, 12850
Greece3 sites
General Hospital of Athens "Laiko"
Athens, 115 27
University General Hospital Attikon
Athens, 124 62
University General Hospital of Heraklion
Heraklion, Crete, 711 10
Serbia3 sites
Institute of Rheumatology, Belgrade
Belgrade, 11000
Military Medical Academy
Belgrade, 11000
Clinical Centre Nis
Niš, 18000
United Kingdom3 sites
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Leicester General Hospital
Leicester, LE5 4PW
Guy's Hospital
London, SE1 9RT
Australia2 sites
The Prince of Wales Hospital
Randwick, New South Wales, 2031
Princess Alexandra Hospital
Woolloongabba, 4102
Canada2 sites
CHU de Quebec-Universite Laval Research Centre
Québec, G1V 4G2
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
France2 sites
HOP Henri Mondor
Créteil, 94010
HOP La Pitié Salpêtrière
Paris, 75013
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong, 999077
Queen Mary Hospital
Hong Kong, 999077
Malaysia2 sites
Hospital Raja Permaisuri Bainun
Ipoh, 30990
Hospital Tengku Ampuan Rahimah
Klang, 41200
About this study
Official title: A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Effect of BI 655064 Administered as Sub-cutaneous Injections, on Renal Response After One Year of Treatment, in Patients With Active Lupus Nephritis
The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.
- Conditions
- Lupus Nephritis
- Being tested
- BI 655064 dose 1, BI 655064 dose 2, BI 655064 dose 3, Placebo
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 655064 dose 1Drug
BI 655064 dose 2Drug
BI 655064 dose 3Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 655064 dose 1 | Experimental | Not described Receives: Drug: BI 655064 dose 1 |
| BI 655064 dose 2 | Experimental | Not described Receives: Drug: BI 655064 dose 2 |
| BI 655064 dose 3 | Experimental | Not described Receives: Drug: BI 655064 dose 3 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Complete Renal Response (CRR) at Week 52
Complete renal response (CRR) was defined as urine protein (UP) < 0.5 g/day at Week 52 and either estimated glomerular filtration rate (eGFR) within normal range at Week 52 or decrease in eGFR < 20% from baseline at Week 52 if eGFR was below normal range (below lower limit of normal [LLN], where LLN = 90 mL/min).
CRR at Week 52 (derived using UP from the 24 h urine collections) was analyzed using a logistic regression model. Factors in the model included treatment and the covariates race (Asian/Non-Asian) and proteinuria at screening (UP/urine creatinine (UC) <3 or >=3 g/day).
Pairwise comparisons of the modelled proportions of patients with CRR at each dose level to placebo were performed.
Measured: At week 52.
Secondary outcomes (5)
Percentage of Patients With Complete Renal Response (CRR) at Week 26
Complete renal response (CRR) was defined as urine protein (UP) < 0.5 g/day at Week 26 and either estimated glomerular filtration rate (eGFR) within normal range at Week 26 or decrease in eGFR < 20% from baseline at Week 26 if eGFR was below normal range (below lower limit of normal [LLN], where LLN = 90 mL/min).
Measured: At week 26.
Percentage of Patients With Partial Renal Response (PRR) at Week 26
Partial renal response (PRR) was defined as at least 50% reduction of proteinuria from baseline if estimated glomerular filtration rate (eGFR) was within normal range at time of assessment or decrease of eGFR <20% from baseline if eGFR was below normal range at time of assessment.
Measured: At week 26.
Percentage of Patients With Partial Renal Response (PRR) at Week 52
Partial renal response (PRR) was defined as at least 50% reduction of proteinuria from baseline if estimated glomerular filtration rate (eGFR) was within normal range at time of assessment or decrease of eGFR <20% from baseline if eGFR was below normal range at time of assessment.
Measured: At week 52.
Percentage of Patients With Major Renal Response (MRR) at Week 26
Major renal response was defined as follows depending on proteinuria at baseline:
- If baseline proteinuria was <3 g/day and patient had complete renal response (CRR)
- If baseline proteinuria was >= 3 g/day and proteinuria < 1 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR <20% from baseline at Week 26 if eGFR was below normal range (below lower limit of normal (LLN), where LLN = 90 mL/min)
Measured: At week 26.
Percentage of Patients With Major Renal Response (MRR) at Week 52
Major renal response was defined as follows depending on proteinuria at baseline:
- If baseline proteinuria was <3 g/day and patient had complete renal response (CRR)
- If baseline proteinuria was >= 3 g/day and proteinuria < 1 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR <20% from baseline at Week 52 if eGFR was below normal range (below lower limit of normal (LLN), where LLN = 90 mL/min)
Measured: At week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start16 May 2016
- Primary completion23 Jun 2020
- Study completion18 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770170
- Sponsor's protocol ID
- 1293.10
- Other IDs
- 2015-001750-15, 2015
- Status last verified
- Oct 2025
- First submitted
- 11 May 2016
- Last updated
- 16 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Publications
Jayne DR, Steffgen J, Romero-Diaz J, Bajema I, Boumpas DT, Noppakun K, Amano H, Gomez HM, Satirapoj B, Avihingsanon Y, Chawanasuntorapoj R, Madero M, Naumnik B, Recto R, Fagan N, Revollo I, Wu J, Visvanathan S, Furie R. Clinical and Biomarker Responses to BI 655064, an Antagonistic Anti-CD40 Antibody, in Patients With Active Lupus Nephritis: A Randomized, Double-Blind, Placebo-Controlled, Phase II Trial. Arthritis Rheumatol. 2023 Nov;75(11):1983-1993. doi: 10.1002/art.42557. Epub 2023 Aug 17.
PubMed 37192040
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Effect of BI 655064 Administered as Sub-cutaneous Injections, on Renal Response After One Year of Treatment, in Patients With Active Lupus Nephritis
- ClinicalTrials.gov ID
- NCT02770170
- Acronym / sponsor ID
- 1293.10
- Conditions
- Lupus Nephritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 May 2016 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Posted 12 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BI 655064 dose 1 | Experimental | Drug: BI 655064 dose 1 |
| BI 655064 dose 2 | Experimental | Drug: BI 655064 dose 2 |
| BI 655064 dose 3 | Experimental | Drug: BI 655064 dose 3 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females 18-70 years. Women of childbearing potential must be ready and able (as assessed by investigator) to use simultaneously two reliable methods of birth control, one of which must be highly effective. Highly effective method, per ICH M3(R2) is a method that result in a low failure rate of less than 1% per year when used consistently and correctly.
- Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology (ACR) criteria 1997, at least 4 criteria must be documented, one of which must be a positive anti-dsDNA antibody OR a positive antinuclear antibody (ANA) at screening or around time of start of induction therapy
- Lupus Nephritis Class III or IV (International Society of Nephrology (ISN)/Renal Pathology Society (RPS) -2003 classification) with either active or active/chronic disease, co-existing class V permitted, proven by renal biopsy within 3 months prior to screening or during screening if induction therapy has not yet been started
- Active renal disease evidenced by proteinuria ≥ 1.0 g/day [(Uprot/Ucrea) ≥ 1]
- Signed and dated written informed consent
Key exclusion criteria (21 listed)
- Clinically significant current other renal disease
- Glomerular Filtration Rate <30ml/min/1.73m²
- Dialysis within 12m of screening
- Antiphospholipid syndrome
- Diabetes mellitus poorly controlled or known diabetic retinopathy or nephropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 655064 dose 1 | Drug | BI 655064 dose 1 |
| BI 655064 dose 2 | Drug | BI 655064 dose 2 |
| BI 655064 dose 3 | Drug | BI 655064 dose 3 |
| Placebo | Drug | Placebo |
Primary outcome
Percentage of Patients With Complete Renal Response (CRR) at Week 52
Time frame: At week 52.
Complete renal response (CRR) was defined as urine protein (UP) < 0.5 g/day at Week 52 and either estimated glomerular filtration rate (eGFR) within normal range at Week 52 or decrease in eGFR < 20% from baseline at Week 52 if eGFR was below normal range (below lower limit of normal [LLN], where LLN = 90 mL/min). CRR at Week 52 (derived using UP from the 24 h urine collections) was analyzed using a logistic regression model. Factors in the model included treatment and the covariates race (Asian/Non-Asian) and proteinuria at screening (UP/urine creatinine (UC) <3 or >=3 g/day). Pairwise comparisons of the modelled proportions of patients with CRR at each dose level to placebo were performed.
5 secondary outcomes
Percentage of Patients With Complete Renal Response (CRR) at Week 26
Time frame: At week 26.
Percentage of Patients With Partial Renal Response (PRR) at Week 26
Time frame: At week 26.
Percentage of Patients With Partial Renal Response (PRR) at Week 52
Time frame: At week 52.
Percentage of Patients With Major Renal Response (MRR) at Week 26
Time frame: At week 26.
Percentage of Patients With Major Renal Response (MRR) at Week 52
Time frame: At week 52.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37192040Jayne DR, Steffgen J, Romero-Diaz J, Bajema I, Boumpas DT, Noppakun K, Amano H, Gomez HM, Satirapoj B, Avihingsanon Y, Chawanasuntorapoj R, Madero M, Naumnik B, Recto R, Fagan N, Revollo I, Wu J, Visvanathan S, Furie R. Clinical and Biomarker Responses to BI 655064, an Antagonistic Anti-CD40 Antibody, in Patients With Active Lupus Nephritis: A Randomized, Double-Blind, Placebo-Controlled, Phase II Trial. Arthritis Rheumatol. 2023 Nov;75(11):1983-1993. doi: 10.1002/art.42557. Epub 2023 Aug 17.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Related trials for Lupus Nephritis
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
74 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 655064 dose 1, BI 655064 dose 2 and BI 655064 dose 3 in people with Lupus Nephritis, run by Boehringer Ingelheim at 74 sites in 20 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 5 inclusion and 21 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 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Japan, Germany, Poland, Philippines and 15 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 Jul 2021). 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?
Percentage of Patients With Complete Renal Response (CRR) at Week 52 (time frame: At week 52.). 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 NCT02770170, which also lists 1 linked publication.
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 16 Oct 2025.