Long-term Follow-up for Evaluating the Safety of CS20AT04 in Subject with Lupus Nephritis

Korábbi kezelés

• patients a history of kidney dialysis or during of the scheduled dialysis clinical trials within 2 weeks prior to the screening.
• Patients who were administered drug of the follow within 6 months prior to the screening.
  • nitrogen mustard, chlorambucil, vin·cris·tine, procarbazine, Abatacept, Rituximab, Belimumab Patients who were administered drug of the follow within 3 months prior to the screening.
  • Anti-TNF therapy(Etanercept, adalimumab, Infliximab, golimumab, Tocilizumab) Interleukin-1 receptor antagonist(anakinra) Intravenous immunoglobulin(IVIG) Plasmapheresis
• If that may affect proteinuria increased capacity or begin taking medication(ACE inhibitors, ARB (Angiotensin Receptor Blocker)) (However, more than four weeks allowed capacity, taking is possible during the trial period without changing capacity).
• Patients who showed myocardial infarction or angina on ECG at screening, or received stent procedure or bypass.
• Patients who were administered another study drug 3 months prior to the study.
• Patients are expected to be administered the combination contraindicated drugs about inevitable or taker within clinical trial.
• Class III due to stable prothrombin time of warfarin therapy
• Patients who previously received stem cell therapy.

Más betegség

• Those who do not kidney disease for SLE.
• Patients with a history of hypersensitivity, such as heavy metal poisoning similar to drug testing and drug ingredients.
• Patients a history Major organs (kidney, liver, lung, heart) transplant or liver hematopoietic cells / transplant or during of scheduled transplantation clinical trial.
• Tested positive for hepatitis B(HBsAg, Anti-HBcAB, HBV-DNA) and hepatitis C(Anti-HCV, HCV-RNA).
• Patients a history of anaphylactic reaction for the parenteral administration of a monoclonal antibody or contrast agent, a mouse protein or human.
• Patients with a history of malignancy within 5 years prior to the screening(basal cell carcinoma of skin, squamous cell carcinoma of skin, or cervical intraepithelial neoplasia are excluded).
• Patients with systemic infection at screening.
• Uncontrolled hypertension or diabetes.
• Patients with severe mental disease(for example, schizophrenia, bipolar disorder etc;).
• Lupus anticoagulant group, and are not associated with liver disease or stable anticoagulation 3 grade partial thromboplastin time

Laborértékek

• Patients whose e-GFR ≤ 30mL/min at screening.
• Except as permitted in the following Case and laboratory test results than moderate adverse events(NCI-CTC (National Cancer Institute-Common Toxicity Criteria) version 4.0) grade 3.
• Lupus due to hepatitis and alcoholic liver disease, are not associated with uncontrolled diabetes or viral hepatitis stable 3 grade gamma glutamyl transferase (GGT) increases. If it appears to be less than ALT and / or AST is above all on the second level.
• Stable grade 3 neutropenia or white blood cell count

Életkor

• Women of childbearing age are not implement adequate contraception during clinical trials. the proper method of contraception, which has Oral contraceptive continued more than four weeks, a surgical procedures including the insertion loop, condom use etc. and Medically it is determined that there is no possibility of pregnant women do not belong to women of childbearing age due to the ovary removal, hysterectomy and menopause, etc.

Egyéb

• A person who do not agree to participate in this follow up observational study among the subjects enrolled in a phase 1 clinical trial using CS20AT04.
  • \*Phase I clinical trial exclusion criteria
• Those who are hypersensitive to antibiotics including penicillin and streptomycin.
• Pregnant women or nursing women.
• Subjects who by the investigator to make them ineligible for participation in this clinical study.

• A Person who enrolled in a phase 1 clinical trial using CS20AT04 (CS20AT04-LN101) and administered CS20AT04 and has been 3 months.
• A person who voluntarily consent to participate in this observational study
  • \*Phase I clinical trial Inclusion Criteria
• Patients with HLA-haplo-matched bone marrow donor is less than 70 years old.
• Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
• Patients had suffered from active renal disease in the past or patients has active renal disease now. Active renal disese should have include below.
  • Spot urine protein/creatinine ratio ≥ 1.0 and ① \>5 RBC/HPF, ② \>5 WBC/HPF, ③ columnar cell.
  • Biopsy confirmed active type III or type IV, or type V lupus nephritis. Patients can be immunosuppressive agent to , steroids, taking, such as anti-Malarials (hydroxychloroquine) in a certain capacity, during the test period, to maintain the same capacity before 4-weeks screening.
  • Patients who consented to participate in the study in writing by themselves or their legal representatives.