Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil in Living Donor Kidney Transplantation

University of Khartoum

Status and phase: Unknown; Phase 4

Conditions: Kidney Transplant Rejection

Treatments: Drug: Interleukin 2 Receptor Antagonist; Drug: Antithymocyte Immunoglobulin (Rabbit)

Study type: Interventional

Funder types: Other

Identifiers

NCT03789006

033546

Details and patient eligibility

About

Kidney transplantation is the best available treatment option for patients with end stage renal disease. However, kidney transplantation requires life-long use of immunosuppressive medication. Because of the high cost of these medications we need to carefully evaluate the cost-effectiveness of each drug regimen, especially in low-middle income countries. The objective of this clinical trial is to compare the efficiency and cost of two immunosuppressive protocols after living donor kidney transplantation: (1) antithymocyte globulin, tacrolimus, azathioprine and prednisolone versus (2) basiliximab, tacrolimus, mycophenolate mofetil and prednisolone.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult end-stage renal disease patients
• First living donor kidney transplant.
• Moderate immunological risk.

Exclusion criteria

• Low immunological risk (HLA mismatches 000/100/010/110 with negative PRA).

• High immunological risk (child to mother or husband to wife transplant, 2 DR mismatches).

  • Known hypersensitivity to any of the study medication.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

ATG

Active Comparator group

Description:

Induction with antithymocyte immunoglobulin (Rabbit) (Grafalon) and maintenance with tacrolimus, azathioprine and prednisolone

Treatment:

Drug: Antithymocyte Immunoglobulin (Rabbit)

BAS

Active Comparator group

Description:

Induction with interleukin 2 receptor antagonist (basiliximab) and maintenance with tacrolimus, mycophenolate mofetil and prednisolone

Treatment:

Drug: Interleukin 2 Receptor Antagonist