De Novo Kidney TransplantationPhase 2NCT00617604
A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients
A Phase 2 study testing Alefacept, Tacrolimus and Mycophenolate Mofetil in people with De Novo Kidney Transplantation, run by Astellas Pharma Inc at 33 sites in 12 countries.
Trial summary
The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- De Novo Kidney Transplantation
- What is being tested?
- Alefacept, Tacrolimus and Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 33 sitesin 12 countries
- Study dates
- Dec 2007to Sep 2009
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject with end stage kidney disease who is a suitable candidate for primary kidney transplantation or retransplantation
- Male or female subject at least 18 years of age and younger than 65 years
- Subject receiving a kidney transplant from a non-human leucocyte antigen (HLA) identical living donor or deceased HLA identical/non-HLA identical donor between 5 and 59 years of age with compatible ABO blood type (Blood group system A, B, AB and 0)
Who cannot join
- Subject has a panel reactivity antibody grade > 20% in the previous 6 months and/or had had a previous graft survival shorter than 1 year due to immunological reasons
- Subject received a kidney transplant from a non-heart beating donor
- Subject has received a kidney transplant from a 50 - 59 year old donor with two of the following three factors: history of hypertension, cerebrovascular accident as cause of death, final pre-procurement serum creatinine > 1.5 mg/dL (united network for organ sharing [UNOS] expanded criteria donor)
- Cold ischemia time of the donor kidney is ≥ 30 hours
Trial locations and contacts
33 sites in 12 countries.
33 sites in 12 countries
France7 sites
Study site
Créteil, 94010
Study site
Le Kremlin-Bicêtre, 94275
Study site
Montpellier, 34295
Study site
Nantes, 44093
Study site
Nice, 6002
Study site
Paris, 75475
Study site
Toulouse, 31054
Belgium5 sites
Study site
Brussels, 1070
Study site
Brussels, 1200
Study site
Ghent, 9000
Study site
Leuven, 3000
Study site
Liège, 4000
Spain5 sites
Study site
Barcelona, 8036
Study site
Llobregat, 8907
Study site
Madrid, 28041
Study site
Málaga, 29010
Study site
Santander, 39008
Italy4 sites
Study site
Bologna, 40138
Study site
Padova, 35128
Study site
Rome, 00168
Study site
Siena, 53100
Poland3 sites
Study site
Bydgoszcz, 85-094
Study site
Poznan, 60-479
Study site
Szczecin, 70-111
About this study
Official title: Efficacy and Safety of Alefacept in Combination With Tacrolimus, Mycophenolate Mofetil and Steroids in de Novo Kidney Transplantation - a Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study
The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.
- Conditions
- De Novo Kidney Transplantation
- Being tested
- Alefacept, placebo, Tacrolimus, Mycophenolate Mofetil, Steroids
- 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
IV and subcutaneous injection
placeboDrug
IV and subcutaneous injection
TacrolimusDrug
The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery.
Mycophenolic mofetil was administered as 750 mg twice per day orally
SteroidsDrug
Methylprednisolone or equivalent:
Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus
Prednisone or equivalent:
Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment. Receives: Drug: placebo; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: Steroids |
| Alefacept | Experimental | Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment. Receives: Drug: Alefacept; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: Steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review
Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:
- Grade IA: significant interstitial infiltration (>25% parenchyma affected) and foci of moderate tubulitis;
- Grade IB: significant interstitial infiltration (>25% parenchyma affected) and foci of severe tubulitis;
- Grade IIA: mild to moderate intimal arteritis;
- Grade IIB: severe intimal arteritis comprising >25% of the luminal area;
- Grade III: "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.
A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.
The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Measured: 6 months
Secondary outcomes (19)
Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6
Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:
Acute antibody-mediated rejection - documented anti-donor antibody ('suspicious for' if antibody not demonstrated):
- Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation;
- Grade II: capillary-margination and/or thromboses, C4d+
- Grade III: arterial - v3, C4d+.
A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.
The Kaplan-Meier estimate of biopsy-confirmed antibody-mediated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Measured: 6 months
Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6
Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.
The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated or antibody-mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Measured: 6 months
Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6
Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.
The Kaplan-Meier estimate of biopsy-confirmed acute mixed T-cell mediated and antibody-mediated rejections within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Measured: 6 months
Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6
Acute rejection diagnosed by signs and symptoms, including biopsy-confirmed or suspected (not confirmed by biopsy - i.e. no biopsy was performed or biopsy did not confirm an acute T-cell mediated rejection). The Kaplan-Meier estimate of acute rejection diagnosed by signs and symptoms within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Measured: 6 months
Percentage of Participants With Clinically Treated Acute Rejection at Month 6
Patients who received immunosuppressive medications for the treatment of suspected or biopsy-confirmed acute rejections were considered to have a clinically-treated acute rejection. The Kaplan-Meier estimate of clinically treated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.
Measured: 6 months
Percentage of Participants With Steroid-resistant Acute Rejection at Month 6
A steroid-resistant acute rejection is defined as a rejection episode which did not resolve following treatment with corticosteroids. In the case that a rejection episode was not treated with corticosteroids first but only with antibodies, it was included in this category.
The Kaplan-Meier estimate of steroid-resistant acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Measured: 6 months
Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6
Biopsies were graded by the central reviewer according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.
The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Measured: 6 months
Patient Survival
Patient survival is any participant known to be alive at Month 6. The Kaplan-Meier estimate of patient survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.
Measured: 6 months
Graft Survival
Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at discontinuation of the participant unless superseded by follow-up information.
The Kaplan-Meier estimate of graft survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.
Measured: 6 months
Maximum Histological Grade of All Biopsies After Local Review
The grade of acute rejection was classified according to Banff 97/05 updated version. If a patient had more than 1 rejection episode, the episode with the most severe grade was used.
Acute T-cell mediated rejection:
- Grade IA: significant interstitial infiltration (>25% parenchyma affected) and foci of moderate tubulitis;
- Grade IB: significant interstitial infiltration (>25% parenchyma affected) and foci of severe tubulitis;
- Grade IIA: mild to moderate intimal arteritis;
- Grade IIB: severe intimal arteritis comprising >25% of the luminal area;
- Grade III: "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.
Acute antibody-mediated rejection:
- Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation;
- Grade II: capillary-margination and/or thromboses, C4d+
- Grade III: arterial - v3, C4d+.
Measured: 6 months
Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6
The Kaplan-Meier estimate of anti-lymphocyte antibody therapy for acute rejection (clinically-treated or biopsy-confirmed) within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.
Measured: 6 months
Change From Month 1 in Serum Creatinine
Measured: Month 1, 3, and 6
Change From Month 1 in Glomerular Filtration Rate (GFR)
The GFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
Measured: Month 1, 3, and 6
Change From Month 1 in Creatinine Clearance
The creatinine clearance was calculated according to the Cockcroft-Gault formula.
Measured: Month 1, 3, and 6
GFR Measured by Iothalamate Clearance at Month 6
GFR measured using the iothalamate clearance method and determined by a central laboratory.
Measured: Month 6
Percentage of Participants With Efficacy Failure at Month 6
Efficacy failure is defined as death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading or lost to follow-up.
The Kaplan-Meier estimate of efficacy failure within the first 6 months following transplantation is reported.
Measured: 6 months
Percentage of Participants With Delayed Graft Function
Delayed graft function was defined as the requirement for dialysis within the first week post-transplant.
Measured: 1 week
Percentage of Participants With Treatment Failure at Month 6
Treatment failure is defined as efficacy failure (death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading, lost to follow-up) or early discontinuation of alefacept/placebo at any time (during the 12-week administration period) for any reason. The Kaplan-Meier estimate of treatment failure within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.
Measured: 6 months
Number of Participants With Adverse Events
Causally related was defined as adverse events (AEs) assessed by the Investigator as possibly or probably related to study drug or records where the relationship was missing.
A serious adverse event (SAE) was any untoward medical occurrence that, at any dose:
- Resulted in death.
- Was life-threatening.
- Resulted in persistent or significant disability/incapacity.
- Resulted in congenital anomaly or birth defect.
- Required patient hospitalization or led to prolongation of hospitalization
- Was considered a medically important event.
All rejections and any BK virus, Epstein Barr virus and/or cytomegalovirus infection had to be reported as an SAE
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionSep 2009
- Study completionSep 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.
- Other trials for De Novo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617604
- Sponsor's protocol ID
- 0485-CL-E201
- Other IDs
- 2007-002092-14
- Status last verified
- Jan 2016
- First submitted
- 6 Feb 2008
- Last updated
- 4 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Alefacept in Combination With Tacrolimus, Mycophenolate Mofetil and Steroids in de Novo Kidney Transplantation - a Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study
- ClinicalTrials.gov ID
- NCT00617604
- Acronym / sponsor ID
- 0485-CL-E201
- Conditions
- De Novo Kidney Transplantation
- Keywords
- kidney transplant, alefacept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Posted 4 Feb 2016
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 determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placebo, Drug: Tacrolimus, Drug: Mycophenolate Mofetil, Drug: SteroidsParticipants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment. |
| Alefacept | Experimental | Drug: Alefacept, Drug: Tacrolimus, Drug: Mycophenolate Mofetil, Drug: SteroidsParticipants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject with end stage kidney disease who is a suitable candidate for primary kidney transplantation or retransplantation
- Male or female subject at least 18 years of age and younger than 65 years
- Subject receiving a kidney transplant from a non-human leucocyte antigen (HLA) identical living donor or deceased HLA identical/non-HLA identical donor between 5 and 59 years of age with compatible ABO blood type (Blood group system A, B, AB and 0)
Key exclusion criteria (4 listed)
- Subject has a panel reactivity antibody grade > 20% in the previous 6 months and/or had had a previous graft survival shorter than 1 year due to immunological reasons
- Subject received a kidney transplant from a non-heart beating donor
- Subject has received a kidney transplant from a 50 - 59 year old donor with two of the following three factors: history of hypertension, cerebrovascular accident as cause of death, final pre-procurement serum creatinine > 1.5 mg/dL (united network for organ sharing [UNOS] expanded criteria donor)
- Cold ischemia time of the donor kidney is ≥ 30 hours
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: AmeviveIV and subcutaneous injection | Drug | Alefacept |
| placeboIV and subcutaneous injection | Drug | Placebo |
| TacrolimusThe initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery. | Drug | Alefacept, Placebo |
| Mycophenolate MofetilMycophenolic mofetil was administered as 750 mg twice per day orally | Drug | Alefacept, Placebo |
| SteroidsMethylprednisolone or equivalent: Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus Prednisone or equivalent: Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally | Drug | Alefacept, Placebo |
Primary outcome
Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review
Time frame: 6 months
Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification: * Grade IA: significant interstitial infiltration (>25% parenchyma affected) and foci of moderate tubulitis; * Grade IB: significant interstitial infiltration (>25% parenchyma affected) and foci of severe tubulitis; * Grade IIA: mild to moderate intimal arteritis; * Grade IIB: severe intimal arteritis comprising >25% of the luminal area; * Grade III: "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
19 secondary outcomes
Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6
Time frame: 6 months
Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6
Time frame: 6 months
Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6
Time frame: 6 months
Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6
Time frame: 6 months
Percentage of Participants With Clinically Treated Acute Rejection at Month 6
Time frame: 6 months
Percentage of Participants With Steroid-resistant Acute Rejection at Month 6
Time frame: 6 months
Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6
Time frame: 6 months
Patient Survival
Time frame: 6 months
Graft Survival
Time frame: 6 months
Maximum Histological Grade of All Biopsies After Local Review
Time frame: 6 months
Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6
Time frame: 6 months
Change From Month 1 in Serum Creatinine
Time frame: Month 1, 3, and 6
Change From Month 1 in Glomerular Filtration Rate (GFR)
Time frame: Month 1, 3, and 6
Change From Month 1 in Creatinine Clearance
Time frame: Month 1, 3, and 6
GFR Measured by Iothalamate Clearance at Month 6
Time frame: Month 6
Percentage of Participants With Efficacy Failure at Month 6
Time frame: 6 months
Percentage of Participants With Delayed Graft Function
Time frame: 1 week
Percentage of Participants With Treatment Failure at Month 6
Time frame: 6 months
Number of Participants With Adverse Events
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- 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.
Central Contact study chair
Astellas Pharma Europe B.V.
33 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alefacept, Tacrolimus and Mycophenolate Mofetil in people with De Novo Kidney Transplantation, run by Astellas Pharma Inc at 33 sites in 12 countries.
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 4 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France, Belgium, Spain, Italy, Poland and 7 more countries. 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. Some participants in this study may receive a placebo. 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 4 Feb 2016). 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 T-cell Mediated Rejection 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 4 Feb 2016.