Adult-onset frequently relapsing or steroid dependent nephrotic syndrome nephrotic syndrome
Conditions
Interventions
IDEC-C2B8 375 mg/m2/dose or placebo (equivalent to IDEC-C2B8 375 mg/m2/dose) should be administered twice at 1-week intervals. Also, 25 weeks after the first dose of IDEC-C2B8 or placebo, the patient
Sponsors
Isaka Yoshitaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients with a previous diagnosis of frequently relapsing or steroid-dependent nephrotic syndrome and urine protein =1.5 x 10(3)/uL Platelet count >=10.0 x 10(4)/uL Hemoglobin count >=8.0 x g/dL (2) Liver AST (GOT)=< 3.0 x the upper limit of normal in institutions ALT (GPT)=< 3.0 x Institutional normal upper limit Total bilirubin=< 2.0 mg/dL (34 umol/L) (3) Patients who are deemed to have preserved heart and lung function. 6. Patients presumed to be alive and observable for more than 12 months 7. Patients who are able to understand the purpose, content and risks of the trial and who have obtained written consent from the patient to participate in the trial. However, in case the patient is under 20 years old at the time of obtaining consent, the consent of the patient's proxy is required in addition to the consent of the patient. 8. In case the patient can be hospitalized for 1 night and 2 days from the day of the first dose of investigational drug to the day after administration.
Exclusion criteria
Exclusion criteria: 1. patients with secondary nephrotic syndrome (including suspected) Secondary nephrotic syndrome refers to nephrotic syndrome caused by IgA nephropathy, diabetic nephropathy, lupus nephritis, amyloid nephropathy, purpuric nephropathy, etc. 2. patients who have been treated with rituximab 3. Patients with an eGFR of 44 mL/min/1.73 m2 or less 4. Patients suffering from malignancy (1) Patients with an active malignancy or who have had a malignancy will be excluded. However, patients with a malignancy who are not prevalent, have not relapsed or flared up within 5 years prior to enrollment in the study, and have not been treated for malignancy (including land-firming, maintenance and prophylactic therapies) will be eligible for enrollment in the study. (2) Patients who have had intraepithelial cancer and who have been surgically cured, as determined by the attending physician, will be eligible for enrollment in the study. 5. patients with the following infectious diseases (1) Patients with HIV (patients with confirmed positive HIV antibodies) (2) Patients who are positive for one or more of the following antibodies: HBs antigen, HBs antibody, HBc antibody, and HCV antibody. However, patients who meet the following criteria will be allowed to enroll. If the patient is positive for HBs antibody and has a history of hepatitis B vaccination, the HBV-DNA quantification test is negative (less than the detection sensitivity). If there is a possibility of positive hepatitis B antibodies, the HBV-DNA quantitative test should be performed in conjunction with the hepatitis B vaccination history confirmed at the screening test. If the patient is positive for HCV antibodies, the HCV-RNA assay should be negative (less than detection sensitivity). (3) Patients with HTLV-1 (patients with confirmed HTLV-1 antibody-positive status). (4) Patients with serious infections (e.g., pneumonia, pyelonephritis, etc.) that require hospitalization or who have had a history of such infections within 6 months prior to enrollment. (5) Patients with opportunistic infections (e.g., cytomegalovirus infection, systemic fungal infection, pneumocystis infection, non-tuberculous mycobacterial infection, etc.), or who have had a history of such infections within 6 months prior to enrollment. (6) Patients with concomitant or suspected active tuberculosis Patients with complications that are judged by the investigator to affect the efficacy and safety evaluation of the study by the investigator (sub-investigator). 7. patients with central nervous system disorders 8. Patients with autoimmune diseases (Hashimoto's disease [chronic thyroiditis], Crohn's disease, ulcerative colitis, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, etc.) or IgA vasculitis. 9. Patients with alcoholism, drug dependence, or mental disorders or psychiatric symptoms 10. Pregnant women, lactating women, and women with a positive pregnancy test (female patients should have a serum human chorionic gonadotropin test. However, a pregnancy test is not required for women who have undergone fertility surgery, women who have had their uterus or both ovaries removed, or women who have been in menopause for more than 1 year). Patients (male and female) who are unable to use contraception during the period from the acquisition of consent to the end of the clinical trial and from the end of the clinical trial to the period instructed by the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Recurrence-free rate at 25 weeks from the date of study administration 2) Time from the start date of the study to relapse 3) Changes in steroid drug dosage and percentage of cases of steroid drug discontinuation at 25 and 49 weeks from the date of study drug initiation 4) Changes in immunosuppressive drug dosage at 25 weeks and 49 weeks from the start date of the study and the percentage of cases in which immunosuppressive drugs were discontinued 5) Changes in renal function parameters at 25 and 49 weeks from the date of study administration 1 urinary protein 2 Serum albumin 3 Total cholesterol 4 Serum creatinine | — |
Contacts
Public ContactYoshitaka Isaka
Osaka University Hospital
Outcome results
None listed