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

NCT ID: NCT03789006

Last Updated: 2019-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-21

Study Completion Date

2024-03-21

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.

Detailed Description

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Conditions

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Kidney Transplant Rejection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ATG

Induction with antithymocyte immunoglobulin (Rabbit) (Grafalon) and maintenance with tacrolimus, azathioprine and prednisolone

Group Type ACTIVE_COMPARATOR

Antithymocyte Immunoglobulin (Rabbit)

Intervention Type DRUG

Induction agent for living donor kidney transplantation

BAS

Induction with interleukin 2 receptor antagonist (basiliximab) and maintenance with tacrolimus, mycophenolate mofetil and prednisolone

Group Type ACTIVE_COMPARATOR

Interleukin 2 Receptor Antagonist

Intervention Type DRUG

Induction agent for living donor kidney transplantation

Interventions

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Antithymocyte Immunoglobulin (Rabbit)

Induction agent for living donor kidney transplantation

Intervention Type DRUG

Interleukin 2 Receptor Antagonist

Induction agent for living donor kidney transplantation

Intervention Type DRUG

Other Intervention Names

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grafalon Basiliximab

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Kidney Diseases and Surgery

UNKNOWN

Sponsor Role collaborator

University of Khartoum

OTHER

Sponsor Role lead

Responsible Party

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Sarra Elamin

Consultant Physician and Nephrologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarra Elamin, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant Nephrologist

Locations

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Doctor Salma Center for Kidney Diseases

Khartoum, , Sudan

Site Status RECRUITING

Countries

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Sudan

Central Contacts

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Sarra Elamin, MD

Role: CONTACT

(+249)912474666

Nazar Zulfo, MD

Role: CONTACT

(+249)900948820

Facility Contacts

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Sarra Elamin, MD

Role: primary

(+249)912474666

Nazar Zulfo, MD

Role: backup

(+249)900948820

Other Identifiers

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033546

Identifier Type: -

Identifier Source: org_study_id

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