Actively Recruiting
A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2024-05-09
270
Participants Needed
10
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent before any study-specific procedures
- Male or female aged 18 to 75 years at screening
- Previous diagnosis of systemic lupus erythematosus (SLE) according to American College of Rheumatology criteria (1997)
- Evidence of active lupus nephritis with biopsy within 2 years showing Class III, IV, or V lupus nephritis
- Urine protein creatinine ratio (UPCR) of at least 1.5 mg/mg for Class III/IV or at least 2 mg/mg for Class V at screening
- If biopsy was done more than 6 months but within 2 years, UPCR must have doubled within 6 months before screening
- Requires high-dose corticosteroids and immunosuppressive therapy based on investigator evaluation
- Willing to take oral mycophenolate mofetil (MMF) during the study
- Fertile subjects must agree to use reliable contraception from consent until 3 months after trial; women of childbearing potential must have negative pregnancy tests at screening and baseline
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73 m2 at screening
- Currently using or planning to use prohibited drugs without required washout
- Currently requiring or expected to require dialysis during the study
- Previous or planned kidney transplant during study period
- Known allergy or contraindication to study drugs including MMF, mycophenolate sodium, cyclosporine, voclosporin, or corticosteroids
- History of drug or alcohol abuse within 2 years before screening
- Malignancy within 5 years except treated basal or squamous cell carcinoma or treated cervical dysplasia with normal follow-up
- Lymphoproliferative disease or previous total lymphoid irradiation
- Severe viral infection within 3 months or known HIV infection
- Active tuberculosis or history of TB without prophylaxis
- Severe cardiovascular disease, poorly controlled hypertension, or prolonged QT interval
- Liver dysfunction exceeding 2.5 times upper limit of normal at screening
- Chronic obstructive pulmonary disease or asthma needing oral steroids
- Bone marrow insufficiency unrelated to SLE
- Active bleeding based on investigator evaluation
- Infections requiring intravenous antibiotics during screening
- Other immune diseases affecting study outcomes except SLE and lupus nephritis
- Live or attenuated vaccines within 4 weeks before screening or during treatment
- Significant unstable physical or mental illness or trauma within 6 months before screening
- Pregnant or breastfeeding women
- Participation in another drug or device trial within 4 weeks or 5 half-lives of prior drug
- Previous participation in voclosporin clinical trials
- Any condition posing risk or affecting study results per investigator assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Actively Recruiting
2
The People's Hospital of Bozhou
Bozhou, Anhui, China
Actively Recruiting
3
Anhui Provincial Hospital
Hefei, Anhui, China
Actively Recruiting
4
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
5
Chincse PLA General Hosptial
Beijing, Beijing Municipality, China
Actively Recruiting
6
Peking University First Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
7
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Actively Recruiting
8
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Actively Recruiting
9
Huashan Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
10
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Actively Recruiting
Research Team
F
Feng Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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