Phase III study for evaluating efficacy and safety of a combination treatment of IDEC-C2B8 with steroid pulse therapy and plasmapheresis for antibody-mediated rejection after kidney transplant.

JRCT ID: jRCT2080224105

Registered date:23/10/2018

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Antibody-mediated rejection (ABMR) after living or cadaveric kidney transplant.
• Date of first enrollment: 28/01/2019
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : IDEC-C2B8
INN of investigational material : rituximab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : One dose (375 mg/m2) of IDEC-C2B8 will be given intravenously (IV) at day 1. If the therapeutic effect is insufficient or additional dosing is necessary, a second dose can be given at day 8.

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

efficacy
Improvement of serum creatinine
Improvement of serum creatinine at 1 month (day 29) after first IDEC-C2B8 administration (day 1).

Secondary Outcome

safety
safety

Key inclusion & exclusion criteria

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

Include criteria

1.Patients who develop or suspect ABMR requiring treatment with IDEC-C2B8.
2.Patients who are 16 years and over at giving written informed consent.
3.Patients or Patient's representative who are able to understand the study protocol and provide the written informed consent.

• Exclude criteria: 1.Patients who have a history of hypersensitivity or severe allergic to murine products.

Related Information

• Primary Sponsor: ZENYAKU KOGYO CO., LTD.
• Secondary Sponsor: -
• Source(s) of Monetary Support: ZENYAKU KOGYO CO., LTD.
• Secondary ID(s): JapicCTI-184166