Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients (INTAC)

Astellas

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: basiliximab; Drug: alemtuzumab; Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: steroids; Drug: rabbit anti-thymocyte globulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00113269

20-04-003

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.

Full description

A 2 arm (1 Active, 1 Active Control) study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, MMF and a rapid steroid withdrawal.

Enrollment: 501 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).

Exclusion criteria

• Patient has previously received an organ transplant other than a kidney
• Patient receiving chronic steroid therapy at time of transplant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

501 participants in 4 patient groups

Alemtuzumab High-Risk Patients

Experimental group

Description:

Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American

Treatment:

Drug: steroids

Drug: mycophenolate mofetil

Drug: alemtuzumab

Drug: tacrolimus

Conventional High-Risk Patients

Active Comparator group

Description:

Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American

Treatment:

Drug: steroids

Drug: rabbit anti-thymocyte globulin

Drug: mycophenolate mofetil

Drug: tacrolimus

Alemtuzumab Low- Risk Patients

Experimental group

Description:

Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American

Treatment:

Drug: steroids

Drug: mycophenolate mofetil

Drug: alemtuzumab

Drug: tacrolimus

Conventional Low-Risk Patients

Active Comparator group

Description:

Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American

Treatment:

Drug: steroids

Drug: mycophenolate mofetil

Drug: tacrolimus

Drug: basiliximab