A Randomized Controlled Trial of Anti-CD20 Together with Anti-CD25 And Anti-CD25 Alone in Induction Phase of Kidney Transplant Recipient with Low to Moderate Immunologic Risk
Phase 3
- Conditions
- Kidney transplant recipientsKidney transplant,induction,rituximab,basiliximab,DSA,rejection
- Registration Number
- TCTR20200717003
- Lead Sponsor
- Ratchadaphiseksomphot Endowment Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- nknown
- Sex
- All
- Target Recruitment
- 124
Inclusion Criteria
1.Age ≥ 20 year olds
2.Living or deceased donor kidney transplantation without preformed DSA
3.Low to moderate risk for kidney transplantation
Exclusion Criteria
- CDC-AHG crossmatching positive
- DSA by Luminex bead positive
- PRA (pre-KT) ≥ 80%
1.ABOi kidney transplantation
2.Second kidney transplantation
3.Hepatitis B or C infection
4.Donor HBV or HCV infection
5.Cardiac arrhythmia or uncorrectable coronary heart disease
6.Severe obstructive lung disease
7.Peptic ulcer perforation
8.Rituximab allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite outcome: De novo DSA, Acute rejection, Graft loss, eGFR < 60 mL/min/1.73 m2 after complete study DSA, allograft biopsy, serum creatinine levels
- Secondary Outcome Measures
Name Time Method Incidence of BK virus and CMV infection Pre-emptive approach or prophylaxis approach Serum BK viral load, Serum CMV DNA