Could biologic drugs offer a better way to treat lupus kidney disease?
NCT ID NCT07340463
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether biologic drugs (belimumab or telitacicept) can improve kidney outcomes in people with active lupus nephritis better than standard therapy. About 50 participants will be randomly assigned to one of three treatment groups for six months. The goal is to see if these targeted drugs can help more patients achieve complete kidney remission with fewer side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Belimumab or Telitacicept (biologic drugs) plus glucocorticoids, with or without mycophenolate mofetil
- What this could lead to
- If successful, this could point toward a more targeted, potentially safer treatment option for lupus nephritis that reduces reliance on standard immunosuppressants.
- What could go wrong
- This is a small, early-phase exploratory trial with only 50 participants, so results may not apply broadly. Biologics can cause serious infections or allergic reactions, and the study does not yet prove long-term safety or effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
Jun 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
14 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1.Signed written informed consent form. 2.Age 14-65 years (inclusive), any gender. 3.Meets the American College of Rheumatology (ACR) SLE diagnostic criteria (1997). 4.All patients have biopsy-confirmed class III/IV ± V LN within the past six months. 5.SLE-DAI score \> 6. 6.Urine protein quantification \> 1.0 g/d. Exclusion Criteria: * 1.Estimated glomerular filtration rate (eGFR) ≥45 ml/min/1.73 m². 2.Patients who have received renal replacement therapy, plasma exchange, immunoadsorption, or high-dose intravenous immunoglobulin (100g) within the past 2 months. 3.Patients with concomitant critical organ damage or lupus crisis (e.g., pulmonary hemorrhage, encephalopathy, heart failure) deemed unsuitable for clinical trial participation by the investigator. 4.Hematological abnormalities: White blood cells \<3000/μL, absolute neutrophil count \<1500/μL, or lymphocytes \<800/μL, platelet count \<50,000/μL (unless due to SLE activity). 5.Liver function abnormalities: ALT, AST, or bilirubin levels exceeding 2 times the upper limit of normal. 6.Known allergy or contraindication to any component of belimumab and/or telitacicept. 7.Active infection or intravenous antibiotic use within 1 month prior to enrollment. 8.Pregnant or breastfeeding women. 9.Current or within the past 3 months: Active hepatitis B, hepatitis C, tuberculosis, cytomegalovirus pneumonia, active fungal infection, syphilis infection, or HIV infection; active peptic ulcer; history of drug abuse or alcoholism; severe malnutrition (BMI \<16 kg/m²). 10.Other conditions: Severe cardiovascular disease potentially life-threatening; chronic obstructive pulmonary disease, or asthma/allergic diseases requiring long-term oral steroid treatment; malignant hypertension; history of malignancy within the past 5 years (except for completely treated basal cell or squamous cell skin cancer or cervical intraepithelial neoplasia). 11.Other situations deemed unsuitable for enrollment by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Lupus nephritis (LN) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Clinical Research Ethics Committee of the General Hospital of Eastern Theater Command of the People's Liberation Army
RECRUITINGNanjing, Jiangsu, 210016, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody aims to wipe out Lupus-Causing immune cells
- Kidney biopsies probed for scarring signal in lupus
- Can a single CAR-T infusion reset the immune system and stop lupus kidney damage?
- Can a single cell therapy calm multiple autoimmune diseases?
- Blood test duo may flag High-Risk lupus kidney patients
- Can remote care and pharmacists improve lupus kidney treatment?