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

NCT03789006 | Unknown Phase 4 DMC

• 1 other identifier: 033546
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Cost of immunosuppressive medication

  1 year post kidney transplant+

Study Arms (2)

ATG

ACTIVE COMPARATOR

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

Drug: Antithymocyte Immunoglobulin (Rabbit)

BAS

ACTIVE COMPARATOR

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

Drug: Interleukin 2 Receptor Antagonist

Interventions

Antithymocyte Immunoglobulin (Rabbit) DRUG

Induction agent for living donor kidney transplantation

Also known as: grafalon

ATG

Interleukin 2 Receptor Antagonist DRUG

Induction agent for living donor kidney transplantation

Also known as: Basiliximab

BAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult end-stage renal disease patients
• First living donor kidney transplant.
• Moderate immunological risk.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Khartoum: lead
• National Center for Kidney Diseases and Surgery: collaborator

Study Sites (1)

Doctor Salma Center for Kidney Diseases

Khartoum, 11111, Sudan

RECRUITING

MeSH Terms

Interventions

Antilymphocyte Serum; Basiliximab

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal

Study Officials

• Sarra Elamin, MD

  Consultant Nephrologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarra Elamin, MD

CONTACT

(+249)912474666; sarraelamin@hotmail.com

Nazar Zulfo, MD

CONTACT

(+249)900948820; nazarzuflo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician and Nephrologist

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: December 25, 2018
• First Posted: December 28, 2018
• Study Start: March 21, 2018
• Primary Completion: March 21, 2022
• Study Completion: March 21, 2024
• Last Updated: January 3, 2019

Record last verified: 2018-12

Locations

SU (1)