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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224105

Enrollment

Registered

2018-10-23

Start date

2019-01-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibody-mediated rejection (ABMR) after living or cadaveric kidney transplant.

Interventions

investigational material(s) Generic name etc : IDEC-C2B8 INN of investigational material : rituximab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigationa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
safety safety	—

Countries

Japan

Contacts

Public ContactIzumi Okugaito

ZENYAKU KOGYO CO., LTD.

Izumi_Okugaito@mail.zenyaku.co.jp+81-3-3946-1113

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026