Kidney TransplantationPhase 4INTACNCT00113269
Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
A Phase 4 study testing basiliximab, rabbit anti-thymocyte globulin and tacrolimus in people with Kidney Transplantation, run by Astellas Pharma Inc at 29 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- basiliximab, rabbit anti-thymocyte globulin and tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 29 sitesUnited States
- Study dates
- May 2005to Mar 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Patient has previously received an organ transplant other than a kidney
- Patient receiving chronic steroid therapy at time of transplant
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Study site
Birmingham, Alabama, 35294
Study site
Chapel Hill, North Carolina, 27599
Study site
Charleston, South Carolina, 29425
Study site
Chicago, Illinois, 60611
Study site
Chicago, Illinois, 60612
Study site
Cincinnati, Ohio, 45267
Study site
Danville, Pennsylvania, 17822
Study site
Denver, Colorado, 80262
Study site
Durham, North Carolina, 27710
Study site
Harrisburg, Pennsylvania, 17105
Study site
Hawthorne, New York, 10532
Study site
Livingston, New Jersey, 07039
Study site
Los Angeles, California, 90057
Study site
Madison, Wisconsin, 53792
Study site
Miami, Florida, 33136
Study site
Milwaukee, Wisconsin, 53226
Study site
New Brunswick, New Jersey, 08901
Study site
New York, New York, 10029
Study site
New York, New York, 10032
Study site
Palo Alto, California, 94304
Study site
Portland, Oregon, 97239
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92123
Study site
San Francisco, California, 94115
Study site
San Francisco, California, 94143
Study site
Tampa, Florida, 33066
Study site
Washington D.C., District of Columbia, 20007
Study site
Washington D.C., District of Columbia, 20010
About this study
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
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.
Read the detailed 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.
- Conditions
- Kidney Transplantation
- Being tested
- basiliximab, rabbit anti-thymocyte globulin, tacrolimus, alemtuzumab, mycophenolate mofetil
- Keywords
- Treatment Effectiveness, Treatment Efficacy, Anti-rejection therapy, Immunosuppression, Therapy, antirejection, Renal Transplantation, Transplantation, Kidney, Transplantation, Renal, Grafting, Kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
basiliximabDrug
Also called simulect
IV
rabbit anti-thymocyte globulinDrug
Also called Thymoglobulin
IV
tacrolimusDrug
Also called Prograf, FK506
oral
alemtuzumabDrug
Also called campath
Intravenous (IV)
Also called MMF, CellCept
oral
steroidsDrug
IV and/or oral
| Study group | Role | What they receive |
|---|---|---|
| Alemtuzumab High-Risk Patients | Experimental | Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American Receives: Drug: tacrolimus; Drug: alemtuzumab; Drug: mycophenolate mofetil; Drug: steroids |
| Conventional High-Risk Patients | Active comparator | Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American Receives: Drug: rabbit anti-thymocyte globulin; Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: steroids |
| Alemtuzumab Low- Risk Patients | Experimental | Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American Receives: Drug: tacrolimus; Drug: alemtuzumab; Drug: mycophenolate mofetil; Drug: steroids |
| Conventional Low-Risk Patients | Active comparator | Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American Receives: Drug: basiliximab; Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (10)
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.
Measured: End of Study (36 months)
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.
Measured: End of Study (36 months)
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.
Measured: End of Study (36 months)
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.
Measured: End of Study (36 months)
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.
Measured: 12 months
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.
Measured: End of Study (36 months)
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.
Measured: 12 months
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.
Measured: End of Study (36 months)
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.
Measured: 1 month and End of Study (36 months)
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.
Measured: 1 month and End of Study (36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2005 (estimated)
- Study startMay 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Central Contact, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113269
- Sponsor's protocol ID
- 20-04-003
- Acronym
- INTAC
- Status last verified
- Aug 2011
- First submitted
- 7 Jun 2005
- Last updated
- 11 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21591943
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00113269
- Acronym / sponsor ID
- INTAC / 20-04-003
- Conditions
- Kidney Transplantation
- Keywords
- Treatment Effectiveness, Treatment Efficacy, Anti-rejection therapy, Immunosuppression, Therapy, antirejection, Renal Transplantation, Transplantation, Kidney, Transplantation, Renal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 Jun 2005 (estimated)
- Results
- Posted 8 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alemtuzumab High-Risk Patients | Experimental | Drug: tacrolimus, Drug: alemtuzumab, Drug: mycophenolate mofetil, Drug: steroidsAlemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American |
| Conventional High-Risk Patients | Active comparator | Drug: rabbit anti-thymocyte globulin, Drug: tacrolimus, Drug: mycophenolate mofetil, Drug: steroidsRabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American |
| Alemtuzumab Low- Risk Patients | Experimental | Drug: tacrolimus, Drug: alemtuzumab, Drug: mycophenolate mofetil, Drug: steroidsAlemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American |
| Conventional Low-Risk Patients | Active comparator | Drug: basiliximab, Drug: tacrolimus, Drug: mycophenolate mofetil, Drug: steroidsBasiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- Patient has previously received an organ transplant other than a kidney
- Patient receiving chronic steroid therapy at time of transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| basiliximabAlso: simulectIV | Drug | Conventional Low-Risk Patients |
| rabbit anti-thymocyte globulinAlso: ThymoglobulinIV | Drug | Conventional High-Risk Patients |
| tacrolimusAlso: Prograf, FK506oral | Drug | Alemtuzumab High-Risk Patients, Alemtuzumab Low- Risk Patients, Conventional High-Risk Patients, Conventional Low-Risk Patients |
| alemtuzumabAlso: campathIntravenous (IV) | Drug | Alemtuzumab High-Risk Patients, Alemtuzumab Low- Risk Patients |
| mycophenolate mofetilAlso: MMF, CellCeptoral | Drug | Alemtuzumab High-Risk Patients, Alemtuzumab Low- Risk Patients, Conventional High-Risk Patients, Conventional Low-Risk Patients |
| steroidsIV and/or oral | Drug | Alemtuzumab High-Risk Patients, Alemtuzumab Low- Risk Patients, Conventional High-Risk Patients, Conventional Low-Risk Patients |
Primary outcome
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.
10 secondary outcomes
Overall Patient Incidence of BCAR
Time frame: End of Study (36 months)
Efficacy Failure
Time frame: End of Study (36 months)
Clinically Treated Acute Rejection
Time frame: End of Study (36 months)
Time to First BCAR
Time frame: End of Study (36 months)
Graft Survival at 12 Months
Time frame: 12 months
Overall Graft Survival
Time frame: End of Study (36 months)
Patient Survival at 12 Months
Time frame: 12 months
Overall Patient Survival
Time frame: End of Study (36 months)
Renal Function Abnormalities Based on Creatinine Clearance
Time frame: 1 month and End of Study (36 months)
Renal Function Abnormalities Based on Serum Creatinine
Time frame: 1 month and End of Study (36 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21591943Hanaway 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.
- Link to Prescribing InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Central Contact study director
Astellas Pharma Global Development
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing basiliximab, rabbit anti-thymocyte globulin and tacrolimus in people with Kidney Transplantation, run by Astellas Pharma Inc at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00113269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.