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| Name | Class |
|---|---|
| National Center for Kidney Diseases and Surgery | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG | Active Comparator | Induction with antithymocyte immunoglobulin (Rabbit) (Grafalon) and maintenance with tacrolimus, azathioprine and prednisolone |
|
| BAS | Active Comparator | Induction with interleukin 2 receptor antagonist (basiliximab) and maintenance with tacrolimus, mycophenolate mofetil and prednisolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antithymocyte Immunoglobulin (Rabbit) | Drug | Induction agent for living donor kidney transplantation |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of immunosuppressive medication | Overall cost of immunosuppressive medication during first year post kidney transplant | 1 year post kidney transplant+ |
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Inclusion Criteria:
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarra Elamin, MD | Contact | (+249)912474666 | sarraelamin@hotmail.com | |
| Nazar Zulfo, MD | Contact | (+249)900948820 | nazarzuflo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sarra Elamin, MD | Consultant Nephrologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doctor Salma Center for Kidney Diseases | Recruiting | Khartoum | 11111 | Sudan |
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Randomized clinical trial
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| Interleukin 2 Receptor Antagonist | Drug | Induction agent for living donor kidney transplantation |
|
|
| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D000077552 | Basiliximab |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
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