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.
Phase 3
Completed
- Conditions
- Antibody-mediated rejection (ABMR) after living or cadaveric kidney transplant.
- Registration Number
- JPRN-jRCT2080224105
- Lead Sponsor
- ZENYAKU KOGYO CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 20
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
1.Patients 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>Improvement of serum creatinine<br>Improvement of serum creatinine at 1 month (day 29) after first IDEC-C2B8 administration (day 1).
- Secondary Outcome Measures
Name Time Method safety<br>safety