A multicenter, open-label study investigating efficacy and safety of GB-0998 for antibody-mediated rejection after renal transplant

JRCT ID: jRCT2031200175

Registered date:28/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: AMR after renal transplant
• Date of first enrollment: 28/10/2020
• Target sample size: 20
• Study type: Interventional

Intervention(s)

From the time of providing informed consent to the time of completing blood sampling after initiating the second dose of IVIG
Medications for treatment of AMR,which are listed as follows (including drugs of off-label use) Rabbit anti-human thymocyte globulin, rituximab, basiliximab, bortezomib, and eculizumab

Outcome(s)

• Primary Outcome: Renal graft survival rate 6 months after the initiation of study treatment

Secondary Outcome

1.changes in renal function from baseline (serum creatinine, eGFR, and urinary protein)
2.Percentage of the patients whose antibody titer decreased as compared with that at baseline

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Male and female patients aged 16 years or older at the time of providing informed consent
2.Patients who receive explanation using the informed consent form and patient information sheet approved by an institutional review board and provide the signed informed consent form before conducting procedures specified in the study (If the patient is a minor, both patient himself/herself and legally acceptable representative* must sign the informed consent form.)
3.Patients who meet the following criteria and are judged by the investigator or subinvestigator to develop AMR after renal transplant:
1)AMR due to anti-HLA antibody, anti-non-HLA antibody, anti-A antibody, and/or anti-B antibody judged by the investigator or subinvestigator based on the antibody test results in the screening period
2)Active/chronic active AMR of the Banff classification (2017); note that electron microscopy and genetic marker testing specified in the Banff classification are not essential
3)For chronic active AMR, the serum creatinine level determined by the pre-enrollment laboratory test does not exceed 2.5 mg/dL

Exclude criteria

Patients who fall under any of the following items are excluded from the study

1.Patients who received prohibited concomitant medications, which are specified separately, in the period between providing informed consent and initiation of study treatment
2.Patients who are receiving a dialysis treatment or who are judged by the investigator or subinvestigator to require that
3.Patients with T cell-mediated rejection (TCMR) however,patients with a diagnosis of mixed rejection of AMR and TCMR are to be included in the study
4.Patients who have a concurrent severe hepatic/cardiovascular disease that requires hospitalization and are judged by the investigator or subinvestigator to be inappropriate as subjects of the study.
5.Patients receiving treatment for malignant tumor
6.Patients who concurrently have thromboembolism or who are judged by the investigator or subinvestigator to be at high risk for the onset of that, for example, patients with a history of thromboembolism
7.Patients with a serum IgA level of <5 mg/dL, as a result of the laboratory test in the screening period.If a serum IgA level has been confirmed by the previous laboratory test, this measurement is unnecessary.
8.Patients who need a constant treatment with IVIG at the time of providing informed consent (e.g., chronic inflammatory demyelinating polyradiculoneuropathy)
9.Pregnant, pregnancy test-positive, parturient, or lactating women or patients with pregnancy intentions during the study period. A pregnancy test is conducted by measurement of serum chorionic gonadotropin. However, women who meet the following conditions can skip the pregnancy test by recording which condition is met.
History of bilateral salpingo-oophorectomy or hysterectomy
Premature ovarian failure confirmed by a specialist physician
Postmenopause (amenorrhea for continuous 12 months without other medical causes)
10.Patients who received other study drugs within 90 days before providing informed consent or who are participating in other clinical studies at the time of providing informed consent
11.Patients with a history of hypersensitivity against the ingredient of the study drug
12.Patients who are judged by the investigator or subinvestigator to be inappropriate as subjects of the study

Related Information

• Primary Sponsor: Nakagawa Ken