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

Kidney Transplantation Clinical Trial

— INTAC  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00113269
• Other study ID #: 20-04-003
• Status: Completed
• Phase: Phase 4
• First received: June 7, 2005
• Last updated: August 9, 2011
• Start date: May 2005
• Est. completion date: March 2009

Study information

• Verified date: August 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• basiliximab
IV
• rabbit anti-thymocyte globulin
IV
• tacrolimus
oral
• alemtuzumab
Intravenous (IV)
• mycophenolate mofetil
oral
• steroids
IV and/or oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hanaway MJ, Woodle ES, Mulgaonkar S, Peddi VR, Kaufman DB, First MR, Croy R, Holman J; INTAC Study Group. Alemtuzumab induction in renal transplantation. N Engl J Med. 2011 May 19;364(20):1909-19. doi: 10.1056/NEJMoa1009546. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 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.	6 months	No
Secondary	Overall Patient Incidence of BCAR	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.	End of Study (36 months)	No
Secondary	Efficacy Failure	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.	End of Study (36 months)	No
Secondary	Clinically Treated Acute Rejection	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.	End of Study (36 months)	No
Secondary	Time to First BCAR	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.	End of Study (36 months)	No
Secondary	Graft Survival at 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.	12 months	No
Secondary	Overall Graft Survival	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.	End of Study (36 months)	No
Secondary	Patient Survival at 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.	12 months	No
Secondary	Overall Patient Survival	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.	End of Study (36 months)	No
Secondary	Renal Function Abnormalities Based on Creatinine Clearance	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.	1 month and End of Study (36 months)	No
Secondary	Renal Function Abnormalities Based on Serum Creatinine	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.	1 month and End of Study (36 months)	No

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