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.

JRCT ID: jRCT2080224107

Registered date:23/10/2018

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Living donor kidney transplantation recipients with pre-formed anti-HLA antibody and/or donor-specific antibody.
• Date of first enrollment: 21/05/2019
• Target sample size: 23
• 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 : Two doses (375 mg/m2) of IDEC-C2B8 will be given intravenously (IV) at day -14 and day -1 prior to the transplantation. A second dose can be omitted according to recipient's condition.
Generic name etc : FK506
INN of investigational material : tacrolimus
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : FK506 will be given orally twice daily. The first administration of FK506 should be initiated between day -28 and day -7 prior to the transplantation, and continue until the previous day (day -1) of the transplantation. In principle, the recipients will receive initial tacrolimus dose of 0.15 mg/kg. The subsequent doses will be adjusted in accordance with the immunosuppression protocol in each institution.
Generic name etc : FK506E(MR4)
INN of investigational material : tacrolimus
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : FK506E(MR4) will be given orally once daily. The first administration of FK506E(MR4) should be initiated between day -28 and day -7 prior to the transplantation, and continue until the previous day (day -1) of the transplantation. In principle, the recipients will receive initial tacrolimus dose of 0.15 - 0.20 mg/kg. The subsequent doses will be adjusted in accordance with the immunosuppression protocol in each institution.

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

Outcome(s)

Primary Outcome

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 Outcome

safety
safety

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 74age old
• Gender: Both

Include 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.

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

Related Information

• Primary Sponsor: ZENYAKU KOGYO CO., LTD.
• Secondary Sponsor: Astellas Pharma Inc.
• Source(s) of Monetary Support: ZENYAKU KOGYO CO., LTD.,Astellas Pharma Inc.
• Secondary ID(s): JapicCTI-184168