A Phase 4 interventional study of Antithymocyte Immunoglobulin (Rabbit) and Interleukin 2 Receptor Antagonist in Kidney Transplant Rejection, sponsored by University of Khartoum. Status unknown at 1 site in Sudan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-03.
Sponsored by University of Khartoum · Phase 4, Interventional, and Prevention
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.
University of Khartoum is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Exclusion Criteria:
High immunological risk (child to mother or husband to wife transplant, 2 DR mismatches).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Induction with antithymocyte immunoglobulin (Rabbit) (Grafalon) and maintenance with tacrolimus, azathioprine and prednisolone
Drug: Antithymocyte Immunoglobulin (Rabbit)
Induction with interleukin 2 receptor antagonist (basiliximab) and maintenance with tacrolimus, mycophenolate mofetil and prednisolone
Drug: Interleukin 2 Receptor Antagonist
Induction agent for living donor kidney transplantation
Also known as: grafalon
Induction agent for living donor kidney transplantation
Also known as: Basiliximab
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
Time frame: 6 months post kidney transplant
One year graft survival
One year kidney allograft survival, uncensored for patient death
Time frame: 1 year post kidney transplant
Cost of immunosuppressive medication
Overall cost of immunosuppressive medication during first year post kidney transplant
Time frame: 1 year post kidney transplant+
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Thymoglobulin · Basiliximab
University of Khartoum