Kidney TransplantationPhase 2NCT00543569
A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients
A Phase 2 study testing Alefacept, tacrolimus and basiliximab in people with Kidney Transplantation, run by Astellas Pharma Inc at 38 sites in United States.
Trial summary
A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients. 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?
- Alefacept, tacrolimus and basiliximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 38 sitesUnited States
- Study dates
- Feb 2008to Feb 2011
- Phase
- Phase 2
- 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
- Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure
- Subject is a recipient of a de novo kidney transplant
- Subject is a recipient of a kidney from a non-human leukocyte antigen (HLA) identical related living donor, a non-related living donor, or a deceased donor
Who cannot join
- Subject has a screening (pre-operative)estimated cluster of differentiation (CD) 4+ T-cell count of < 250 cells/µL
- Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30 hours
- Recipient has a positive T or B-cell cross match by investigational site's standard method of determination
- Subject will receive a kidney from a 50-65 year old deceased donor with one of the following:
- History of hypertension and a terminal serum creatinine > 1.5 mg/dL
- Cerebrovascular accident as cause of death and a terminal serum creatinine > 1.5 mg/dL
- History of hypertension and cerebrovascular accident as cause of death and a terminal serum creatinine > 1.5 mg/dL
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
University of Michigan
Ann Arbor, Michigan, 48109
Medical College of Georgia, Augusta
Augusta, Georgia, 30921
University of Colorado Health Science Center
Aurora, Colorado, 80045
University of Maryland Center
Baltimore, Maryland, 21201
Tufts Medical Center
Boston, Massachusetts, 02111
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Buffalo General Hospital
Buffalo, New York, 14203
University of North Carolina
Chapel Hill, North Carolina, 27599
Rush - Presbyterian - St. Lukes Medical Center
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
University Hospital of Cleveland
Cleveland, Ohio, 44106
Baylor University Medical Center
Dallas, Texas, 75246
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida, Shands Hospital, Gainesville
Gainesville, Florida, 32610
Pinnacle Health at Harrisburg
Harrisburg, Pennsylvania, 17101
Methodist Hospital Research Institute of Houston
Houston, Texas, 77030
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
University of Kentucky
Lexington, Kentucky, 40536
St. Barnabas Medical Center
Livingston, New Jersey, 07039
Loma Linda University Medical Center
Loma Linda, California, 92354
University of Southern California - University Hospital
Los Angeles, California, 90033
St. Vincent/National Institute of Transplantation
Los Angeles, California, 90057
University of Wisconsin Hospital
Madison, Wisconsin, 53792
Methodist University Hospital - Memphis
Memphis, Tennessee, 38104
Mt. Sinai School of Medicine
New York, New York, 10029
New York Presbyterian Hospital - Cornell
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Legacy Transplant Services
Portland, Oregon, 97210
Oregon Health & Science University
Portland, Oregon, 97239
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298
UC Davis Medical Center
Sacramento, California, 95817
University of Utah Medical Center
Salt Lake City, Utah, 84132
UCSD
San Diego, California, 92103
California Institute of Renal Research/Sharp Memorial Hospital
San Diego, California, 92123
University of California - San Francisco
San Francisco, California, 94143
University of Washington Medical Center
Seattle, Washington, 98195
Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients
A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.
Read the detailed description
This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de novo kidney transplant recipients.
- Conditions
- Kidney Transplantation
- Being tested
- Alefacept, tacrolimus, basiliximab, mycophenolate mofetil, Corticosteroids
- Keywords
- kidney transplant, alefacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlefaceptDrug
Also called Amevive, ASP0485
Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks.
tacrolimusDrug
Also called Prograf, FK506
The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.
basiliximabDrug
Also called Simulect
Administered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3.
Also called CellCept, MMF
Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms.
CorticosteroidsDrug
Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus/MMF/Basiliximab | Active comparator | Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months. Receives: Drug: tacrolimus; Drug: basiliximab; Drug: mycophenolate mofetil; Drug: Corticosteroids |
| Alefacept QW/Tacrolimus/MMF | Experimental | Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months. Receives: Drug: Alefacept; Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: Corticosteroids |
| Alefacept QW/Tacrolimus | Experimental | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. Receives: Drug: Alefacept; Drug: tacrolimus; Drug: Corticosteroids |
| Alefacept QOW/Tacrolimus/MMF | Experimental | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. Receives: Drug: Alefacept; Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.
The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit.
Measured: 6 months
Secondary outcomes (23)
Patient Survival at Month 6 and Month 12
Patient survival is any participant who is known to be alive 6 months and 12 months after the skin closure date.
The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Measured: 6 months and 12 months
Graft Survival at Month 6 and Month 12
Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months and 12 months after the skin closure date. Graft loss was defined as patient death, retransplant, permanent return to dialysis (dialysis greater than 30 days) or transplant nephrectomy.
The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Measured: 6 months and 12 months
Percentage of Participants With BCAR at Month 12 Assessed by Local Review
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.
The Kaplan-Meier estimates at Day 365 was used for the analyses at 12 months. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Measured: 12 months
Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review
Rejection episodes were confirmed by biopsy by a central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.
The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Measured: 6 months and 12 months
Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.
The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Measured: 6 months and 12 months
Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review
Rejection episodes were confirmed by biopsy by the central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.
The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Measured: 6 months and 12 months
Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12
The glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) method.
Measured: Week 4, Month 6 and Month 12
Change From Week 4 in GFR by Iothalamate Clearance at Month 6
The glomerular filtration rate was measured directly using iothalamate clearance.
Measured: Week 4 and Month 6
Change From Week 4 in Serum Creatinine at Month 6 and 12
Measured: Week 4 and Month 6 and 12
Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review
Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to local review, or lost to follow-up.
Measured: 6 months and 12 months
Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review
Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to central review, or lost to follow-up.
Measured: 6 months and 12 months
Time to First BCAR Assessed by Local Review
The time to first BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.
Measured: 12 months
Time to First BCAR Assessed by Central Review
The time to first BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.
Measured: 12 months
Time to First T-cell Mediated BCAR Assessed by Local Review
The time to first T-cell mediated BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1.
Measured: 12 months
Time to First T-cell Mediated BCAR Assessed by Central Review
The time to first T-cell mediated BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a T-cell mediated BCAR are included in the analysis.
Measured: 12 months
Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.
Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.
Measured: 6 months and 12 months
Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.
Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.
Measured: 6 months and 12 months
Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12
Patients who received immunosuppressive medications for the treatment of suspected or BCAR were considered to have a clinically-treated acute rejection.
Measured: 6 months and 12 months
Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12
Participants with histologically proved Banff Grade II or III rejection could receive anti-rejection therapy with anti-lymphocyte antibodies per institutional protocol.
The use of anti-lymphocyte antibody therapy at any time during a suspected or proven rejection episode for the treatment of acute rejection was considered an event.
Measured: 6 months and 12 months
Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12
All participants were evaluated for the incidence of multiple rejection episodes (clinically treated and/or BCAR as assessed by the local reviewer) through 6 months and 12 months.
Measured: 6 months and 12 months
Percentage of Participants With Treatment Failure at Month 6 and 12
Treatment failure was defined as death, graft loss, BCAR (local review), lost to follow-up or early discontinuation of treatment regimen. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Measured: 6 months and 12 months
Gastrointestinal Quality of Life Index Score Over Time
The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) symptom severity score. The GIQLI is a 36-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past 2 weeks on a scale from 0 (all of the time) to 4 (never). Possible overall scores ranged from 0 to 4, with higher scores indicating a better quality of life according to the different symptomatic criteria.
Measured: Months 1, 3, 6, and 12
Gastrointestinal Symptom Rating Scale Scores Over Time
The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Symptom Rating Scale Scores (GSRS). The GSRS a 15-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms.
Measured: Months 1, 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startFeb 2008
- Primary completionFeb 2011
- Study completionFeb 2011
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global DevelopmentPrincipal Investigator, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543569
- Sponsor's protocol ID
- 0485-CL-U201
- Status last verified
- Nov 2015
- First submitted
- 11 Oct 2007
- Last updated
- 11 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT00543569
- Acronym / sponsor ID
- 0485-CL-U201
- Conditions
- Kidney Transplantation
- Keywords
- kidney transplant, alefacept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Oct 2007 (estimated)
- Results
- Posted 11 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.
Detailed description
This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de novo kidney transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus/MMF/Basiliximab | Active comparator | Drug: tacrolimus, Drug: basiliximab, Drug: mycophenolate mofetil, Drug: CorticosteroidsParticipants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months. |
| Alefacept QW/Tacrolimus/MMF | Experimental | Drug: Alefacept, Drug: tacrolimus, Drug: mycophenolate mofetil, Drug: CorticosteroidsParticipants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months. |
| Alefacept QW/Tacrolimus | Experimental | Drug: Alefacept, Drug: tacrolimus, Drug: CorticosteroidsParticipants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| Alefacept QOW/Tacrolimus/MMF | Experimental | Drug: Alefacept, Drug: tacrolimus, Drug: mycophenolate mofetil, Drug: CorticosteroidsParticipants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure
- Subject is a recipient of a de novo kidney transplant
- Subject is a recipient of a kidney from a non-human leukocyte antigen (HLA) identical related living donor, a non-related living donor, or a deceased donor
Key exclusion criteria (7 listed)
- Subject has a screening (pre-operative)estimated cluster of differentiation (CD) 4+ T-cell count of < 250 cells/µL
- Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30 hours
- Recipient has a positive T or B-cell cross match by investigational site's standard method of determination
- Subject will receive a kidney from a 50-65 year old deceased donor with one of the following:
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 |
|---|---|---|
| AlefaceptAlso: Amevive, ASP0485Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks. | Drug | Alefacept QOW/Tacrolimus/MMF, Alefacept QW/Tacrolimus, Alefacept QW/Tacrolimus/MMF |
| tacrolimusAlso: Prograf, FK506The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations. | Drug | Alefacept QOW/Tacrolimus/MMF, Alefacept QW/Tacrolimus, Alefacept QW/Tacrolimus/MMF, Tacrolimus/MMF/Basiliximab |
| basiliximabAlso: SimulectAdministered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3. | Drug | Tacrolimus/MMF/Basiliximab |
| mycophenolate mofetilAlso: CellCept, MMFAdministered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms. | Drug | Alefacept QOW/Tacrolimus/MMF, Alefacept QW/Tacrolimus/MMF, Tacrolimus/MMF/Basiliximab |
| CorticosteroidsCorticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol. | Drug | Alefacept QOW/Tacrolimus/MMF, Alefacept QW/Tacrolimus, Alefacept QW/Tacrolimus/MMF, Tacrolimus/MMF/Basiliximab |
Primary outcome
Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review
Time frame: 6 months
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit.
23 secondary outcomes
Patient Survival at Month 6 and Month 12
Time frame: 6 months and 12 months
Graft Survival at Month 6 and Month 12
Time frame: 6 months and 12 months
Percentage of Participants With BCAR at Month 12 Assessed by Local Review
Time frame: 12 months
Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review
Time frame: 6 months and 12 months
Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review
Time frame: 6 months and 12 months
Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review
Time frame: 6 months and 12 months
Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12
Time frame: Week 4, Month 6 and Month 12
Change From Week 4 in GFR by Iothalamate Clearance at Month 6
Time frame: Week 4 and Month 6
Change From Week 4 in Serum Creatinine at Month 6 and 12
Time frame: Week 4 and Month 6 and 12
Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review
Time frame: 6 months and 12 months
Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review
Time frame: 6 months and 12 months
Time to First BCAR Assessed by Local Review
Time frame: 12 months
Time to First BCAR Assessed by Central Review
Time frame: 12 months
Time to First T-cell Mediated BCAR Assessed by Local Review
Time frame: 12 months
Time to First T-cell Mediated BCAR Assessed by Central Review
Time frame: 12 months
Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
Time frame: 6 months and 12 months
Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
Time frame: 6 months and 12 months
Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12
Time frame: 6 months and 12 months
Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12
Time frame: 6 months and 12 months
Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12
Time frame: 6 months and 12 months
Percentage of Participants With Treatment Failure at Month 6 and 12
Time frame: 6 months and 12 months
Gastrointestinal Quality of Life Index Score Over Time
Time frame: Months 1, 3, 6, and 12
Gastrointestinal Symptom Rating Scale Scores Over Time
Time frame: Months 1, 3, 6, and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Senior Medical Director study director
Astellas Pharma Global Development
Principal Investigator principal investigator
University of Michigan
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alefacept, tacrolimus and basiliximab in people with Kidney Transplantation, run by Astellas Pharma Inc at 38 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 3 inclusion and 7 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 11 Dec 2015). 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?
Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2015.