IDEC-C2B8 clinical phase III trial

JRCT ID: jRCT2051200045

Registered date:11/09/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Adult-onset frequently relapsing or steroid dependent nephrotic syndrome
• Date of first enrollment: 23/09/2020
• Target sample size: 64
• Study type: Interventional
• Intervention(s): 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 should receive another dose of IDEC-C2B8 375 mg/m2/dose or placebo (equivalent to IDEC-C2B8 375 mg/m2/dose).

Outcome(s)

• Primary Outcome: Recurrence-free period

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. patients with a previous diagnosis of frequently relapsing or steroid-dependent nephrotic syndrome and urine protein <0.3 g/gCr in two or more urine protein quantitative measurements after starting steroid therapy for the most recent relapse
(1)Time of confirmation of urine protein <0.3 g/gCr
1) frequently relapsing nephrotic syndrome
If a urine protein test of <0.3 g/gCr is found on 2 or more consecutive occasions with more than 1 day's clearance
2) Steroid-dependent nephrotic syndrome
If <0.3 g/gCr is found in the second urine protein test conducted more than 4 weeks after the first urine protein test and <0.3 g/gCr is found in the second urine protein test
(2)Definition of nephrotic syndrome, etc.
1)Nephrotic syndrome
Proteinuria
Urine protein to urine creatinine ratio of 3.5 g/gCr or higher in urine at any time.
Hypoalbuminemia
Serum albumin level below 3.0 g/dL. Serum total protein below 6.0 g/dL is also helpful.
Edema
Dyslipidemia (high LDL cholesterol)
2) Steroid-dependent nephrotic syndrome
Failure to discontinue steroids because of two or more relapses after reduction or discontinuation of steroid medication.
3) Frequently relapsing nephrotic syndrome
two or more recurrences during 6 - month period.
2.Patients who are at least 18 years of age at the time of initial diagnosis of nephrotic syndrome.
3.Patients who were 18 years of age or older at the time of obtaining consent.
4.Patients with more than 5 CD20-positive cells/ uL in the peripheral blood.
5.Patients with preserved function of major organs other than the kidneys
(1) Blood
Neutrophil count >=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.

Exclude 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 investigator (assigned).
Patients who have had an organ transplant (except for cornea and hair transplants)
13. patients participating in clinical trials or clinical research involving interventions within 30 days prior to obtaining consent for this trial
14.Patients whom the investigator considers inappropriate to participate in the trial

Related Information

• Primary Sponsor: Isaka Yoshitaka
• Source(s) of Monetary Support: Zenyaku Kogyo Co., Ltd.