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

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ClinicalTrials.gov Identifier: NCT03789006
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
National Center for Kidney Diseases and Surgery
Information provided by (Responsible Party):
Sarra Elamin, University of Khartoum

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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Rejection Drug: Antithymocyte Immunoglobulin (Rabbit) Drug: Interleukin 2 Receptor Antagonist Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : March 21, 2022
Estimated Study Completion Date : March 21, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ATG
Induction with antithymocyte immunoglobulin (Rabbit) (Grafalon) and maintenance with tacrolimus, azathioprine and prednisolone
Drug: Antithymocyte Immunoglobulin (Rabbit)
Induction agent for living donor kidney transplantation
Other Name: grafalon

Active Comparator: BAS
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
Other Name: Basiliximab




Primary Outcome Measures :
  1. Incidence of acute rejection [ Time Frame: 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

  2. One year graft survival [ Time Frame: 1 year post kidney transplant ]
    One year kidney allograft survival, uncensored for patient death


Secondary Outcome Measures :
  1. Cost of immunosuppressive medication [ Time Frame: 1 year post kidney transplant+ ]
    Overall cost of immunosuppressive medication during first year post kidney transplant



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789006


Contacts
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Contact: Sarra Elamin, MD (+249)912474666 sarraelamin@hotmail.com
Contact: Nazar Zulfo, MD (+249)900948820 nazarzuflo@gmail.com

Locations
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Sudan
Doctor Salma Center for Kidney Diseases Recruiting
Khartoum, Sudan, 11111
Contact: Sarra Elamin, MD    (+249)912474666    sarraelamin@hotmail.com   
Contact: Nazar Zulfo, MD    (+249)900948820    nazarzuflo@gmail.com   
Sponsors and Collaborators
University of Khartoum
National Center for Kidney Diseases and Surgery
Investigators
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Principal Investigator: Sarra Elamin, MD Consultant Nephrologist

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Responsible Party: Sarra Elamin, Consultant Physician and Nephrologist, University of Khartoum
ClinicalTrials.gov Identifier: NCT03789006     History of Changes
Other Study ID Numbers: 033546
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycophenolic Acid
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Interleukin-2
Azathioprine
Tacrolimus
Basiliximab
Antilymphocyte Serum
Thymoglobulin
Immunoglobulins
Antibodies
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Glucocorticoids