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

Kidney Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03789006
• Other study ID #: 033546
• Status: Recruiting
• Phase: Phase 4
• Start date: March 21, 2018
• Est. completion date: March 21, 2024

Study information

• Verified date: December 2018
• Source: University of Khartoum
• Contact: Sarra Elamin, MD
• Phone: (+249)912474666
• Email: sarraelamin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 21, 2024
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Intervention

Drug:
• Antithymocyte Immunoglobulin (Rabbit)
Induction agent for living donor kidney transplantation
• Interleukin 2 Receptor Antagonist
Induction agent for living donor kidney transplantation

Locations

Country	Name	City	State
Sudan	Doctor Salma Center for Kidney Diseases	Khartoum

Sponsors (2)

Lead Sponsor	Collaborator
University of Khartoum	National Center for Kidney Diseases and Surgery

Country where clinical trial is conducted

Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	One year graft survival	One year kidney allograft survival, uncensored for patient death	1 year post kidney transplant
Secondary	Cost of immunosuppressive medication	Overall cost of immunosuppressive medication during first year post kidney transplant	1 year post kidney transplant+