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

Phase 4

• Conditions: Kidney Transplant Rejection
• Interventions: Drug: Antithymocyte Immunoglobulin (Rabbit); Drug: Interleukin 2 Receptor Antagonist

• Registration Number: NCT03789006
• Lead Sponsor: University of Khartoum

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-21
• Status Verified: 2018-12
• Study First Submitted: 2018-12-25
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-28
• Last Update Submitted: 2018-12-31
• Last Update Posted: 2019-01-03
• Primary Completion: 2022-03-21
• Study Completion: 2024-03-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATG	Antithymocyte Immunoglobulin (Rabbit)	Induction with antithymocyte immunoglobulin (Rabbit) (Grafalon) and maintenance with tacrolimus, azathioprine and prednisolone
BAS	Interleukin 2 Receptor Antagonist	Induction with interleukin 2 receptor antagonist (basiliximab) and maintenance with tacrolimus, mycophenolate mofetil and prednisolone

Primary Outcome Measures

Name	Time	Method
Incidence of acute rejection	6 months post kidney transplant	The incidence of acute rejection will include clinically diagnosed and biopsy proven acute rejection. Clinically diagnosed rejection includes at least 30% acute rise in serum creatinine level. Biopsy proven rejection will include both cellular and antibody mediated rejection according to Banff 2017 criteria
One year graft survival	1 year post kidney transplant	One year kidney allograft survival, uncensored for patient death

Secondary Outcome Measures

Name	Time	Method
Cost of immunosuppressive medication	1 year post kidney transplant+	Overall cost of immunosuppressive medication during first year post kidney transplant

Trial Locations

Locations (1)

Doctor Salma Center for Kidney Diseases; 🇸🇩 Khartoum, Sudan