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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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200717003
Enrollment
124
Registered
2020-07-17
Start date
2020-07-17
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplant recipients Kidney transplant&#44

Interventions

Rituximab (Truxima) 200 mg + NSS 200 ml IV drip (follow protocol) and Basiliximab (Simulect) 20 mg + NSS 100 ml IV drip in 1&#45
hour ,Basiliximab (Simulect) 20 mg + NSS 100 ml IV drip in 1&#45
hour วัน
Experimental Drug,Experimental Drug
Rituximab/Basiliximab,Basiliximab

Sponsors

Ratchadaphiseksomphot Endowment Fund
Lead Sponsor
Ratchadaphiseksomphot Endowment Fund
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Composite outcome: De novo DSA&#44; Acute rejection&#44; Graft loss&#44; eGFR < 60 mL/min/1.73 m2 after complete study DSA&#44; allograft biopsy&#44; serum creatinine levels—

Secondary

MeasureTime frame
Incidence of BK virus and CMV infection Pre&#45;emptive approach or prophylaxis approach Serum BK viral load&#44; Serum CMV DNA—

Countries

Thailand

Contacts

Public ContactNatavudh Townamchai

King Chulalongkorn Memorial Hospital and Chulalongkorn University

ntownamchai@gmail.com0894904222

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026