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Tests treatment safety and results for Lupus Nephritis (LN)
Official title Study to Assess Efficacy and Safety of HSK39297 Tablets in Patients With LN
ClinicalTrials.gov ID: NCT07363460
What this study is testing
What is HSK39297 200mgQD?
HSK39297 200mgQD is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for lupus nephritis (ln).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A double-blind,placebo controlled,randomized Phase 2 study to evaluate the safety and tolerability of once-daily, oral administration of 200 or 300 mg HSK39297 tablets versus placebo in Patients With Lupus Nephritis
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Understand and comply with the research requirements, voluntarily participate in the research and sign the informed consent form before starting the...
- Age ≥ 18 and \< 75 years old at screening, gender not limited;
- Positive anti-ANA antibody and/or anti-dsDNA antibody (research center);
- Pathological type of active III or IV lupus nephritis confirmed by renal biopsy within 12 months before screening, with or without type V (adopting...
You likely can't join if
- Evidence of active lupus nephritis exists, and the investigator assesses that it is necessary to receive glucocorticoid combined with MMF treatment...
- First onset or recurrence of lupus nephritis (for people who have received MMF treatment previously and have experienced recurrence, the investigator...
- Female people with reproductive capacity [excluding those who have undergone surgical sterilization (hysterectomy, bilateral tubal ligation...
- The subject has previously failed to respond to treatment with MMF or other mofetil mycophenolate drugs, as assessed by the investigator.
- Allergy to the investigational product or MMF, or contraindications to MMF and glucocorticoids.
- Currently receiving or requiring administration of any drug listed in Section 5.7.2.2 "Prohibited Concomitant Medications" during the study period.
See the full eligibility criteria
- Understand and comply with the research requirements, voluntarily participate in the research and sign the informed consent form before starting the relevant procedures;
- Age ≥ 18 and \< 75 years old at screening, gender not limited;
- Positive anti-ANA antibody and/or anti-dsDNA antibody (research center);
- Pathological type of active III or IV lupus nephritis confirmed by renal biopsy within 12 months before screening, with or without type V (adopting the 2003 International Society of Nephrology/Renal Pathology Working...
- Evidence of active lupus nephritis exists, and the investigator assesses that it is necessary to receive glucocorticoid combined with MMF treatment. Active lupus nephritis must meet the following two criterias: a)...
- First onset or recurrence of lupus nephritis (for people who have received MMF treatment previously and have experienced recurrence, the investigator and the sponsor jointly assess the benefit based on the study's...
- Female people with reproductive capacity [excluding those who have undergone surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral oophorectomy) at least 6 weeks prior to screening or who are...
- The subject has previously failed to respond to treatment with MMF or other mofetil mycophenolate drugs, as assessed by the investigator.
- Allergy to the investigational product or MMF, or contraindications to MMF and glucocorticoids.
- Currently receiving or requiring administration of any drug listed in Section 5.7.2.2 "Prohibited Concomitant Medications" during the study period.
- Receiving systemic glucocorticoid therapy for reasons other than systemic lupus erythematosus or lupus nephritis at screening (dose \> 10 mg/day prednisone or equivalent; dosage conversion details see Appendix 4).
- Received treatment with other investigational drugs within 30 days prior to screening or within 5 half-lives (whichever is longer).
- Presence of rapidly progressive glomerulonephritis at screening (eGFR decline exceeding 50% within 3 months, or less than 50% but with rapid decline risk assessed by the investigator); renal biopsy showing crescents...
- Presence of severe extra-renal manifestations of systemic lupus erythematosus at screening, including but not limited to severe pulmonary hypertension (WHO classification IV or higher), severe pulmonary interstitial...
- Major, unstable, or uncontrolled acute or chronic diseases affecting various systems (e.g., cardiovascular, respiratory, hematological, gastrointestinal, hepatic, renal, neurological systems) within 6 months prior to...
- History of other autoimmune diseases.
- History of any of the following infections: 1) History of encapsulated bacterial infection (e.g., Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae) within 1 year prior to screening; 2) Active...
- Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73m² (calculated by CKD-EPI 2021 formula, see Appendix 5);
- Hematology: neutrophils \< 1 × 10⁹/L; leukocytes \< 2 × 10⁹/L; hemoglobin \< 80 g/L; platelets \< 50 × 10⁹/L;
- Liver function: Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 3 × ULN; Total Bilirubin (TBIL) ≥ 2 × ULN;
- Hepatitis B virus surface antigen (HBsAg) positive, or HBsAg negative but Hepatitis B virus core antibody (HBc-Ab) positive with HBV-DNA detection result higher than the quantitative lower limit; Hepatitis C virus...
- Human Immunodeficiency Virus antibody (HIV-Ab) positive. 17. Pregnant or lactating female people at screening. 18. Other situations deemed unsuitable for participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.