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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03789006

Enrollment

300

Registered

2018-12-28

Start date

2018-03-21

Completion date

2024-03-21

Last updated

2019-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Rejection

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.

Interventions

DRUGAntithymocyte Immunoglobulin (Rabbit)

Induction agent for living donor kidney transplantation

DRUGInterleukin 2 Receptor Antagonist

Induction agent for living donor kidney transplantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Cost of immunosuppressive medication	1 year post kidney transplant+	Overall cost of immunosuppressive medication during first year post kidney transplant

Countries

Sudan

Contacts

Primary ContactSarra Elamin, MD

sarraelamin@hotmail.com(+249)912474666

Backup ContactNazar Zulfo, MD

nazarzuflo@gmail.com(+249)900948820

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026