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Trial record 1 of 1 for:    NCT01265537
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A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf (Astellas)

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ClinicalTrials.gov Identifier: NCT01265537
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Jagbir Gill, University of British Columbia

Brief Summary:
While the incidence of acute rejection and early graft loss have improved dramatically with the advent of newer immunosuppressant medications, improvements in long-term patient and allograft survival after kidney transplantation have not been achieved. The specific drug combination that provides the best outcomes with the least amount of side effects is not known. Each kidney transplant center uses the combination of drugs that they believe is optimal. This study is about identifying whether drugs that are currently approved for use in kidney transplantation can be used in a new combination safely and with potentially fewer side effects than the drug combinations that are currently used at St. Paul's Hospital and other transplant centres.

Condition or disease Intervention/treatment Phase
Acute Graft Rejection Diabetes Drug: Tacrolimus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open Label, Pilot Study Comparing the Use of Low-target Advagraf With Rabbit Antithymocyte Globulin Induction Versus Conventional Target Advagraf With Basiliximab Induction in a Steroid-avoidance Immunosuppressive Protocol for de Novo Renal Transplant Recipients
Actual Study Start Date : June 24, 2011
Actual Primary Completion Date : February 21, 2019
Actual Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Low target tacrolimus (Advagraf)
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Drug: Tacrolimus

Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx:

0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4

Other Name: Advagraf

Active Comparator: Standard target tacrolimus (Advagraf)
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Drug: Tacrolimus

Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1

Table 1

Months post tx

0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.

Other Name: Advagraf




Primary Outcome Measures :
  1. Number of Participants With New Onset Diabetes After Transplant (NODAT) or Acute Rejection [ Time Frame: 6 months post transplant ]
    Composite endpoint of biopsy proven acute rejection and NODAT at 6 months post transplantation. NODAT will be defined as either FPG >7.0mmol/L OR symptoms of hyperglycemia and a random plasma glucose of >11.1 OR 2-h plasma glucose >11.1 during an oral glucose tolerance test(OGTT).


Secondary Outcome Measures :
  1. Number of Participant Deaths [ Time Frame: 6 months post transplant ]
    Death of any participant by end of study.

  2. Number of Participants With Graft Failure [ Time Frame: 6 months post transplant ]
    Any graft failure by the end of the study.

  3. Number of Participants With Dialysis Events [ Time Frame: 6 months post transplant ]
    Any dialysis required by end of study.

  4. Number of Participants With Infection Events [ Time Frame: 6 months post transplant ]
    Any infection (CMV, opportunistic infections including urinary tract infections requiring treatment, pneumonia) by end of study.

  5. Number of Participants With Hospitalization Events [ Time Frame: 6 months post transplant ]
    Any hospitalization by end of study.

  6. Number of Participants With Malignancy Events [ Time Frame: 6 months post transplant ]
    Any malignancy (including post-transplant lymphoproliferative disease) by end of study.

  7. Number of Participants With Cardiovascular Event [ Time Frame: 6 months post transplant ]
    Any cardiovascular events by end of study.

  8. Number of Any Leukopenia Events [ Time Frame: 6 months post transplant ]
    Any leukopenia by end of study.

  9. Number of Leukopenia Events on ≥2 Occasions [ Time Frame: 6 months post transplant ]
    Any leukopenia on ≥2 occasions by end of study.

  10. Change From Baseline in Weight [ Time Frame: baseline to 6 months post transplant ]
    Any changes in weight by end of study.

  11. eGFR at 6 Months [ Time Frame: 6 months post transplant ]
    Participant eGFR value by end of study.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients over 18 years of age who receive a deceased, living unrelated or living related donor renal transplant
  2. No history of pre-existing diabetes mellitus
  3. Not using diabetic medications (insulin, hypoglycemic agents) at the time of transplantation
  4. Random plasma glucose level <11.1 at the time of transplantation
  5. Peak PRA (panel reactive antibody) <30%
  6. Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication
  7. The patient has given written informed consent to participate in the study

Exclusion Criteria:

  1. Patients with primary non-function
  2. Peak PRA>=30%
  3. Multiple organ transplants
  4. HLA (human leukocyte antigen) identical living donor transplant recipients
  5. Cold ischemia time over 36 hours
  6. Nonheart beating donor kidney recipients
  7. Pediatric donor kidney recipients
  8. Donor age>=65 years
  9. Patients who are known to have a positive hepatitis C serology, who are human immunodeficiency virus (HIV) or Hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to study entry are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C will be excluded.
  10. Patients who are Epstein-Barr virus (EBV) negative and are receiving a transplant from an EBV-positive donor (mismatch).
  11. Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or hypersensitivity to drugs similar to those used in the study
  12. Patients with systemic infections
  13. Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator, preclude enrollment in this trial
  14. Inability to cooperate or communicate with the investigator

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): NCT01265537


Locations
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Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
University of British Columbia
Astellas Pharma Canada, Inc.
Investigators
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Principal Investigator: Jagbir Gill, MD UBC / Dept of Medicine / Nephrology
  Study Documents (Full-Text)

Documents provided by Jagbir Gill, University of British Columbia:

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Responsible Party: Jagbir Gill, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT01265537    
Other Study ID Numbers: H10-03047
First Posted: December 23, 2010    Key Record Dates
Results First Posted: February 11, 2020
Last Update Posted: February 11, 2020
Last Verified: February 2020
Keywords provided by Jagbir Gill, University of British Columbia:
Transplant
Tacrolimus
Diabetes after transplant
Acute rejection prevention
New onset diabetes after transplant
Additional relevant MeSH terms:
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Tacrolimus
Basiliximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action