JPRN-jRCT2080224107
Completed
Phase 3
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.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- iving donor kidney transplantation recipients with pre-formed anti-HLA antibody and/or donor-specific antibody.
- Sponsor
- ZENYAKU KOGYO CO., LTD.
- Enrollment
- 23
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
- •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.
Outcomes
Primary Outcomes
Not specified
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