Lupus NephritisPhase 3NCT06406205
A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis
A Phase 3 study testing Voclosporin（QL1074） in people with Lupus Nephritis, run by Qilu Pharmaceutical Co., Ltd. at 10 sites in China.
Trial summary
The purpose of this study is to assess the efficacy of QL1074 compared with placebo in achieving renal response after 52 weeks of therapy in subjects with Active Lupus Nephritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Voclosporin（QL1074）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 10 sitesChina
- Study dates
- 25 Dec 2023to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent before any study-specific procedures are performed.
- Male or female subjects with a minimum age of 18 (or legal age of consent if >18 years) to 75 years of age, inclusive, at the time of screening (Visit 1).
- Previous diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria (1997)
- Subjects with evidence of active nephritis, According to the 2018 International Society of Nephrology/Society of Nephropathology (ISN/RPS) classification criteria for lupus nephritis, defined as follows:
- Kidney biopsy result within 2 years prior to screening indicating Class III, IV (alone or in combination with Class V), or Class V LN, Biopsy results must be reviewed with the Investigator to confirm eligibility.
- UPCR of a minimum of ≥1.5 mg/mg for Class III/IV or to a minimum of ≥2 mg/mg for Class V at screening.
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- If the subject provides a biopsy report within 2 years but more than 6 months before screening, the UPCR needs to be doubled at least within 6 months before screening.
- According to the Investigators' evaluation, subject requires high-dose corticosteroids and immunosuppressive therapy.
- Subject is willing to take oral MMF for the duration of the study, either by continuing current MMF therapy or by initiating it on or before the Baseline Visit.
- Fertile subjects (both male and female) must agree to use reliable contraception methods with their partners from the time of signing the informed consent form until 3 months after the end of the trial; women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.
Who cannot join
- Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of ≤45 mL/minute/1.73 m2 at screening.
- urrently taking or planning to use drugs or treatments listed in the Prohibited Drugs (Section 5.5) during the trial, including not completing the required washout.
- Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
- A previous kidney transplant or planned transplant within study treatment period.
- Any known hypersensitivity or contraindication to any of the drugs planned to be used (including but not limited to: MMF, Mycophenolate Sodium, Cyclosporine, Voclosporin, Corticosteroids) or any components of these drug products.
- Current or medical history of:
Show all 25Show fewer
- The subject has a history of drug abuse or alcohol abuse within 2 years before the screening period;
- Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed;
- Lymphoproliferative disease or previous total lymphoid irradiation;
- Severe viral infection (e.g., cytomegalovirus, hepatitis B virus, hepatitis C virus) within 3 months of screening; or known HIV infection. Severe viral infection is defined as active disease requiring antiviral therapy;
- Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid;
- Other known clinically significant active medical conditions, such as:
- Severe cardiovascular disease including congestive heart failure, history of cardiac dysrhythmia, congenital long QT syndrome or Hypertension with poor control (systolic blood pressure ≥165mmHg and/or diastolic blood pressure ≥105mmHg after treatment with 2 or more drugs). QT interval duration corrected for heart rate using method of Fridericia exceeding 480 msec in the presence of a normal QRS interval (<110 msec) at time of screening will result in exclusion;
- Liver dysfunction (aspartate aminotransferase, alanine aminotransferase, or bilirubin ≥2.5 times the upper limit of normal) at screening and, if abnormal at screening, then confirmed that the levels have returned to <2.5 times upper limit of normal before randomization;
- Chronic obstructive pulmonary disease or asthma requiring oral steroids;
- Bone marrow insufficiency unrelated to active SLE (according to Investigator judgment) with white blood cell count <2.5×109/L; absolute neutrophil count <1.3×109/L; thrombocytopenia (platelet count <50×109/L);
- According to the evaluation of the investigator, the subject suffered from active bleeding;
- Patients with infections requiring intravenous antibiotic treatment (antibacterial drugs, antiviral drugs, antifungal drugs, or antiparasitic drugs) during screening;
- According to the researchers' assessment, the subjects have other congenital or acquired immune diseases (except for SLE and LN), for which the condition or the treatment of the condition may affect the study assessments or outcomes (e.g., scleroderma with significant pulmonary hypertension; any condition for which additional immunosuppression is indicated). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (e.g.,Sjögren's syndrome) are not excluded.
- No vaccines using live vaccines or attenuated live vaccines are allowed in the 4 weeks before the screening and while taking the study treatment.
- According to the evaluation of the investigators, there have been significant, unstable or poorly controlled physical/mental illnesses or traumas that may affect the progress or results of the trial within the first 6 months of the screening period.
- Women who are pregnant or breastfeeding.
- Participated in another drug or device trial within 4 weeks before the screening period or within 5 half-lives of the drug (whichever is longer).
- The subject has participated in previous clinical trials of Voclosporin, was randomly assigned to a group, and received treatment with the trial drug.
- According to the assessment of the investigators, there may be conditions that affect the results of the trial or that the risks to the subjects outweigh the benefits.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Chincse PLA General Hosptial
Beijing, Beijing Municipality
Guangyan CAI, MD, 010-68130297
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Minghui zhao
- Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui
Yongjun Mei
- Recruiting
The People's Hospital of Bozhou
Bozhou, Anhui
Yuhui zhang
- Recruiting
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi
Pengfei zhang
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Hongli Lin
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Lixin Wei
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui
zhu chen
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Long Qian
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality
Jing Chen
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of QLG1074 With Placebo in Achieving Renal Remission in Subjects With Active Lupus Nephritis
The purpose of this study is to assess the efficacy of QL1074 compared with placebo in achieving renal response after 52 weeks of therapy in subjects with Active Lupus Nephritis.
Read the detailed description
The aim of the current study is to investigate whether QL1074, added to the standard of care treatment in active lupus nephritis (LN), is able to reduce disease activity over a treatment period of 52 weeks. The background therapy will be mycophenolate mofetil (MMF) and initial treatment with IV methylprednisolone, followed by a reducing course of oral corticosteroids. Subjects with active LN will be eligible to enter the study. They are required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis. Efficacy will be assessed by the ability of the drug combination to reduce the level of proteinuria (as measured by Urine Protein Creatinine Ratio (UPCR)) while demonstrating an acceptable safety profile.
- Conditions
- Lupus Nephritis
- Being tested
- Voclosporin（QL1074）, 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.
Voclosporin（QL1074）Drug
QL1074 23.7 mg BlD will be administered as a fixed dose without the use of therapeutic drugmonitoring. The protocol contains provisions for management of dose based on safety concerns, in particular, BP and renal function，can be managed by dose reduction and temporary of QL1074 to interruption.
PlaceboDrug
Placebo softgel capsules, identical to 7.9 mg QL1074, will be provided. The administration plan and dosage management regulations are the same as QL1074.
| Study group | Role | What they receive |
|---|---|---|
| Voclosporin（QL1074） | Experimental | oral, 23.7 mg twice daily (BID)，52 weeks Drug: Voclosporin calcineurin inhibitor Other Names: QL1074 Receives: Drug: Voclosporin（QL1074） |
| Placebo Oral Capsule | Placebo comparator | Voclosporin placebo, oral, 3 capsules twice daily (BID)，52 weeks Drug: Placebo Oral Capsule matching placebo capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Renal Remission at Week 52
The primary efficacy endpoint was the number of subjects showing complete renal response at Week 52. Complete renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria： UPCR of ≤0.5 g/g \& eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%
Measured: Week 52
Secondary outcomes (12)
Time to Urine Protein Creatinine Ratio of ≤0.5 g/g(Number of Days)
Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0.5 g/g or less.
Measured: 52 Weeks
Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 g/g or Less
Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 g/g or Less
Measured: 52 Weeks
Number of Subjects With Partial Renal Response at Week 52
Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 52. Baseline UPCR is the average of 2 pre-randomisation values.
Measured: Week 52
Time to 50% Reduction in UPCR (Number of Days)
Time in days to reduction in Urine Protein Creatinine Ratio to decrease by 50% compared to baseline. Baseline is the average of two pre-randomisation values.
Measured: 52 Weeks
Number of Subjects With Partial Renal Response at Week 24
Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 24. Baseline UPCR is the average of 2 pre-randomisation values.
Measured: Week 24
Number of Subjects With Renal Response With Low Dose Steroids
Programmed Renal Response whilst on low dose steroids (<2.5 mg/day) for the preceding 8 Weeks at Weeks 24 and 52
Measured: Week 24 and Week 52
Change From Baseline in UPCR
Change from baseline by visit in Urine Protein Creatinine Ratio. Baseline is the average of two pre-randomisation values.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.
Proportion of subjects experiencing a confirmed 30% decrease or more fom baseline in eGFR at each timepoint
Number of subjects with a 30% or more decrease in estimated glomerular filtration rate compared to baseline at each visit time point that meets diagnostic criteria.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.
Change from baseline by visit in Serum Creatinine, Urine Protein, and estimated Glomerular Filtration rate.
Change from baseline by visit in Serum Creatinine, Urine Protein, and estimated Glomerular Filtration rate. eGFR is corrected to a maximum value of 90 mL/min/1.73 m2
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.
Change From Screening in Immunology Parameters (Complement 3 (C3), C4, and Anti-Double-Stranded DNA)
Change from baseline by visit in Immunology Parameters (Complement 3 (C3), C4, and Anti-Double-Stranded DNA). The immunological baseline data is the numerical value during the screening period.
Measured: Week 24 and Week 52
Change From Baseline in Patient Reported Outcomes
Health-related quality of life (HRQoL) information was collected using the Short Form Health Survey (SF-36) HRQoL assessment and the LupusPRO (v1.7) assessment.
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. Scoring ranges from 0 to 100 with higher scores reflecting better health.
LupusPro assessment is a patient-reported questionnaire regarding the effect of lupus or its treatment on the patient's health, quality of life, and the medical care received related to lupus. The questionnaire consists of 43 questions within 8 HRQOL domains and 4 Non-HRQoL domains. Scores range from 0 to 100 with higher scores reflecting better quality of life.
Measured: Week 12, Week 24 and Week 52
Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI)
The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.
Measured: Week 24 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start25 Dec 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guangyan Cai, MD, Study chair, Chincse PLA General Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406205
- Sponsor's protocol ID
- QLG1074-301
- Status last verified
- May 2024
- First submitted
- 20 Mar 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of QLG1074 With Placebo in Achieving Renal Remission in Subjects With Active Lupus Nephritis
- ClinicalTrials.gov ID
- NCT06406205
- Acronym / sponsor ID
- QLG1074-301
- Conditions
- Lupus Nephritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy of QL1074 compared with placebo in achieving renal response after 52 weeks of therapy in subjects with Active Lupus Nephritis.
Detailed description
The aim of the current study is to investigate whether QL1074, added to the standard of care treatment in active lupus nephritis (LN), is able to reduce disease activity over a treatment period of 52 weeks. The background therapy will be mycophenolate mofetil (MMF) and initial treatment with IV methylprednisolone, followed by a reducing course of oral corticosteroids. Subjects with active LN will be eligible to enter the study. They are required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis. Efficacy will be assessed by the ability of the drug combination to reduce the level of proteinuria (as measured by Urine Protein Creatinine Ratio (UPCR)) while demonstrating an acceptable safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voclosporin（QL1074） | Experimental | Drug: Voclosporin（QL1074）oral, 23.7 mg twice daily (BID)，52 weeks Drug: Voclosporin calcineurin inhibitor Other Names: QL1074 |
| Placebo Oral Capsule | Placebo comparator | Drug: PlaceboVoclosporin placebo, oral, 3 capsules twice daily (BID)，52 weeks Drug: Placebo Oral Capsule matching placebo capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent before any study-specific procedures are performed.
- Male or female subjects with a minimum age of 18 (or legal age of consent if >18 years) to 75 years of age, inclusive, at the time of screening (Visit 1).
- Previous diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria (1997)
- Subjects with evidence of active nephritis, According to the 2018 International Society of Nephrology/Society of Nephropathology (ISN/RPS) classification criteria for lupus nephritis, defined as follows:
- According to the Investigators' evaluation, subject requires high-dose corticosteroids and immunosuppressive therapy.
Key exclusion criteria (25 listed)
- Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of ≤45 mL/minute/1.73 m2 at screening.
- urrently taking or planning to use drugs or treatments listed in the Prohibited Drugs (Section 5.5) during the trial, including not completing the required washout.
- Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
- A previous kidney transplant or planned transplant within study treatment period.
- Any known hypersensitivity or contraindication to any of the drugs planned to be used (including but not limited to: MMF, Mycophenolate Sodium, Cyclosporine, Voclosporin, Corticosteroids) or any components of these drug products.
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 |
|---|---|---|
| Voclosporin（QL1074）QL1074 23.7 mg BlD will be administered as a fixed dose without the use of therapeutic drugmonitoring. The protocol contains provisions for management of dose based on safety concerns, in particular, BP and renal function，can be managed by dose reduction and temporary of QL1074 to interruption. | Drug | Voclosporin（QL1074） |
| PlaceboPlacebo softgel capsules, identical to 7.9 mg QL1074, will be provided. The administration plan and dosage management regulations are the same as QL1074. | Drug | Placebo Oral Capsule |
Primary outcome
Number of Participants With Complete Renal Remission at Week 52
Time frame: Week 52
The primary efficacy endpoint was the number of subjects showing complete renal response at Week 52. Complete renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria： UPCR of ≤0.5 g/g \& eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%
12 secondary outcomes
Time to Urine Protein Creatinine Ratio of ≤0.5 g/g(Number of Days)
Time frame: 52 Weeks
Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 g/g or Less
Time frame: 52 Weeks
Number of Subjects With Partial Renal Response at Week 52
Time frame: Week 52
Time to 50% Reduction in UPCR (Number of Days)
Time frame: 52 Weeks
Number of Subjects With Partial Renal Response at Week 24
Time frame: Week 24
Number of Subjects With Renal Response With Low Dose Steroids
Time frame: Week 24 and Week 52
Change From Baseline in UPCR
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.
Proportion of subjects experiencing a confirmed 30% decrease or more fom baseline in eGFR at each timepoint
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.
Change from baseline by visit in Serum Creatinine, Urine Protein, and estimated Glomerular Filtration rate.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.
Change From Screening in Immunology Parameters (Complement 3 (C3), C4, and Anti-Double-Stranded DNA)
Time frame: Week 24 and Week 52
Change From Baseline in Patient Reported Outcomes
Time frame: Week 12, Week 24 and Week 52
Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI)
Time frame: Week 24 and Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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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.
Guangyan Cai, MD study chair
Chincse PLA General Hosptial
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Voclosporin（QL1074） in people with Lupus Nephritis, run by Qilu Pharmaceutical Co., Ltd. at 10 sites in China.
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 10 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Guo (0531-55821177, feng11.guo@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Complete Renal Remission at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2024.