Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients (INTAC)
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| ClinicalTrials.gov Identifier: NCT00113269 |
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Recruitment Status :
Completed
First Posted : June 8, 2005
Results First Posted : July 8, 2011
Last Update Posted : August 11, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Transplantation | Drug: basiliximab Drug: rabbit anti-thymocyte globulin Drug: tacrolimus Drug: alemtuzumab Drug: mycophenolate mofetil Drug: steroids | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 501 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | May 2005 |
| Actual Primary Completion Date : | March 2009 |
| Actual Study Completion Date : | March 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Alemtuzumab High-Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
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Drug: tacrolimus
oral
Other Name: Prograf, FK506 Drug: alemtuzumab Intravenous (IV)
Other Name: campath Drug: mycophenolate mofetil oral
Other Names:
Drug: steroids IV and/or oral |
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Active Comparator: Conventional High-Risk Patients
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
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Drug: rabbit anti-thymocyte globulin
IV
Other Name: Thymoglobulin Drug: tacrolimus oral
Other Name: Prograf, FK506 Drug: mycophenolate mofetil oral
Other Names:
Drug: steroids IV and/or oral |
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Experimental: Alemtuzumab Low- Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
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Drug: tacrolimus
oral
Other Name: Prograf, FK506 Drug: alemtuzumab Intravenous (IV)
Other Name: campath Drug: mycophenolate mofetil oral
Other Names:
Drug: steroids IV and/or oral |
|
Active Comparator: Conventional Low-Risk Patients
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
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Drug: basiliximab
IV
Other Name: simulect Drug: tacrolimus oral
Other Name: Prograf, FK506 Drug: mycophenolate mofetil oral
Other Names:
Drug: steroids IV and/or oral |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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): NCT00113269
| United States, Alabama | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Los Angeles, California, United States, 90057 | |
| Palo Alto, California, United States, 94304 | |
| San Diego, California, United States, 92123 | |
| San Francisco, California, United States, 94115 | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20007 | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Miami, Florida, United States, 33136 | |
| Tampa, Florida, United States, 33066 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60611 | |
| Chicago, Illinois, United States, 60612 | |
| United States, New Jersey | |
| Livingston, New Jersey, United States, 07039 | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| Hawthorne, New York, United States, 10532 | |
| New York, New York, United States, 10029 | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Danville, Pennsylvania, United States, 17822 | |
| Harrisburg, Pennsylvania, United States, 17105 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Director: | Central Contact | Astellas Pharma Global Development |
Publications:
| Responsible Party: | Clinical Trial Registries, Astellas Pharma Global Development |
| ClinicalTrials.gov Identifier: | NCT00113269 |
| Other Study ID Numbers: |
20-04-003 |
| First Posted: | June 8, 2005 Key Record Dates |
| Results First Posted: | July 8, 2011 |
| Last Update Posted: | August 11, 2011 |
| Last Verified: | August 2011 |
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Treatment Effectiveness Treatment Efficacy Anti-rejection therapy Immunosuppression Therapy, antirejection |
Renal Transplantation Transplantation, Kidney Transplantation, Renal Grafting, Kidney |
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Mycophenolic Acid Alemtuzumab Tacrolimus Thymoglobulin Antilymphocyte Serum Basiliximab 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 Antineoplastic Agents, Immunological |