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

Study Overview
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Brief Summary
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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.

Official Title
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Efficiency of Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil When Used in Combination With Tacrolimus and Prednisolone in Living Donor Kidney Transplantation

Conditions
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Kidney Transplant Rejection

Intervention / Treatment
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* Drug: Antithymocyte Immunoglobulin (Rabbit)
* Drug: Interleukin 2 Receptor Antagonist


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ATG<br>Induction with antithymocyte immunoglobulin (Rabbit) (Grafalon) and maintenance with tacrolimus, azathioprine and prednisolone | Drug: Antithymocyte Immunoglobulin (Rabbit)<br>* Induction agent for living donor kidney transplantation<br>* Other names: grafalon;|
| Active Comparator: BAS<br>Induction with interleukin 2 receptor antagonist (basiliximab) and maintenance with tacrolimus, mycophenolate mofetil and prednisolone | Drug: Interleukin 2 Receptor Antagonist<br>* Induction agent for living donor kidney transplantation<br>* Other names: Basiliximab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute rejection | 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 | 6 months post kidney transplant | 
| One year graft survival | One year kidney allograft survival, uncensored for patient death | 1 year post kidney transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of immunosuppressive medication | Overall cost of immunosuppressive medication during first year post kidney transplant | 1 year post kidney transplant+ |