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.

Phase 3

Completed

• Conditions: iving donor kidney transplantation recipients with pre-formed anti-HLA antibody and/or donor-specific antibody.

• Registration Number: JPRN-jRCT2080224107
• Lead Sponsor: ZENYAKU KOGYO CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 23

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>IDEC-C2B8: Graft survival rate<br>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.<br>safety<br>pharmacokinetics<br>FK506/FK506E(MR4): Transplant execution rate, Safety, Pharmacokinetics<br>Transplant execution rate after completion of the desensitization protocol. Safety and pharmacokinetics during the desensitization protocol.

Secondary Outcome Measures

Name	Time	Method
safety<br>safety