Phase III study for evaluating efficacy and safety of desensitization based on IDEC-C2B8 in living donor kidney transplantation recipients with pre-formed anti-HLA antibody and/or donor-specific antibody. Phase III study for evaluating efficacy, safety and pharmacokinetics of pre-transplant administration of FK506 or FK506E(MR4) for 7 to 28 days in living donor kidney transplantation recipients.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224107

Enrollment

Registered

2018-10-23

Start date

2019-05-21

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

Living donor kidney transplantation recipients with pre-formed anti-HLA antibody and/or donor-specific antibody.

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: [Recipients] 1.Japanese recipients who are scheduling the living kidney transplantation. 2.Recipients with pre-formed anti-HLA antibody and/or donor-specific antibody. 3.Recipients who are 16 - 75 years of age at giving written informed consent. 4.Recipients or Recipient's representative who are able to understand the study protocol and provide the written informed consent. [Donors] 1.Donors who are selected by the Inclusion criteria and the Exclusion criteria defined by the each medical institution according to the Consensus Statement of the Amsterdam Forum (2004), the guideline of living donor kidney transplantation (the Japan Society for Transplantation), donor guideline of living donor kidney transplantation (the Japan Society for Transplantation and the Japan Society for Clinical Renal Transplantation) and the ethical guideline of the Japan Society for Transplantation.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
efficacy IDEC-C2B8: Graft survival rate Graft survival rate at 24 weeks post-transplant (day 168) presumed from the previous report will be updated with the graft survival rate at 24 weeks (6 months) after transplantation of this trial. safety pharmacokinetics FK506/FK506E(MR4): Transplant execution rate, Safety, Pharmacokinetics Transplant execution rate after completion of the desensitization protocol. Safety and pharmacokinetics during the desensitization protocol.	—

Measure

Time frame

efficacy IDEC-C2B8: Graft survival rate Graft survival rate at 24 weeks post-transplant (day 168) presumed from the previous report will be updated with the graft survival rate at 24 weeks (6 months) after transplantation of this trial. safety pharmacokinetics FK506/FK506E(MR4): Transplant execution rate, Safety, Pharmacokinetics Transplant execution rate after completion of the desensitization protocol. Safety and pharmacokinetics during the desensitization protocol.

—

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