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OpenTrials
Completed

NCT Number: NCT00113269

Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients

The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Birmingham, Alabama, United States

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About this study

A 2 arm (1 Active, 1 Active Control) study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, MMF and a rapid steroid withdrawal.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).

Exclusion criteria

  • Patient has previously received an organ transplant other than a kidney
  • Patient receiving chronic steroid therapy at time of transplant

Treatment and study plan

Basiliximab

Drug

IV

Other names: simulect

rabbit anti-thymocyte globulin

Drug

IV

Other names: Thymoglobulin

Tacrolimus

Drug

oral

Other names: Prograf, FK506

Alemtuzumab

Drug

Intravenous (IV)

Other names: campath

Mycophenolate mofetil

Drug

oral

Other names: MMF, CellCept

Steroids

Drug

IV and/or oral

Primary outcomes

  1. Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months

    Time frame: 6 months

    A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3).

    Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st.

Secondary outcomes

  1. Overall Patient Incidence of BCAR

    Time frame: End of Study (36 months)

    Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A & 1B) to Moderate (2A & 2B) to Severe (3).

    End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.

  2. Efficacy Failure

    Time frame: End of Study (36 months)

    Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure.

    End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.

  3. Clinically Treated Acute Rejection

    Time frame: End of Study (36 months)

    Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection.

    End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.

  4. Time to First BCAR

    Time frame: End of Study (36 months)

    Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR.

    End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.

  5. Graft Survival at 12 Months

    Time frame: 12 months

    Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure.

    Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.

  6. Overall Graft Survival

    Time frame: End of Study (36 months)

    Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival.

    End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.

  7. Patient Survival at 12 Months

    Time frame: 12 months

    Patient survival is defined as not dead within 12 months after skin closure.

    Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.

  8. Overall Patient Survival

    Time frame: End of Study (36 months)

    Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival.

    End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.

  9. Renal Function Abnormalities Based on Creatinine Clearance

    Time frame: 1 month and End of Study (36 months)

    Increases in creatinine clearance usually indicates an improvement.

    Change in creatinine clearance from month 1 was calculated.

    Change from 1 month is calculated by month 36 - month 1.

  10. Renal Function Abnormalities Based on Serum Creatinine

    Time frame: 1 month and End of Study (36 months)

    Decrease in serum creatinine usually indicates an improvement.

    Change in creatinine clearance from month 1 was calculated.

    Change from 1 month is calculated by month 36 - month 1.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Phase 4, Randomized, Open-label, Comparative, Multicenter Study to Assess the Safety and Efficacy of Induction Agents, Alemtuzumab, Basiliximab or Rabbit Anti-thymocyte Globulin in Combination With Tacrolimus, MMF, and a Rapid Steroid Withdrawal in Renal Transplant Recipients

Acronym: INTAC

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jun 8, 2005
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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