Kidney TransplantationPhase 3NCT00064701
Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients
A Phase 3 study testing Tacrolimus Modified Release (MR), Tacrolimus and cyclosporine microemulsion in people with Kidney Transplantation, run by Astellas Pharma Inc at 57 sites in 3 countries.
Trial summary
The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Tacrolimus Modified Release (MR), Tacrolimus and cyclosporine microemulsion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- 57 sitesin 3 countries
- Study dates
- Jun 2003to Mar 2009
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Recipient of a primary or retransplanted non-human leukocyte antigen (HLA)-identical living or non-HLA-identical cadaveric kidney transplant
- Age greater or equal to 12 years
Who cannot join
- Recipient or donor is known seropositive for human immunodeficiency virus (HIV)
- Has current malignancy or history of malignancy
- Has significant liver disease
- Has uncontrolled concomitant infection or any other unstable medical condition
- Is receiving everolimus or enteric coated mycophenolic acid at any time during the study
- Received kidney with a cold ischemia time of equal or more than 36 hours
- Received kidney transplant from a cadaveric donor equal or more than 60 years of age
- Received intravenous immunoglobulin (IVIG) therapy prior to randomization
Trial locations and contacts
57 sites in 3 countries.
57 sites in 3 countries
United States48 sites
Study site
Albany, New York, 12208
Study site
Ann Arbor, Michigan, 48109-0364
Study site
Augusta, Georgia, 30912
Study site
Birmingham, Alabama, 35294
Study site
Boston, Massachusetts, 02214
Study site
Buffalo, New York, 14203
Study site
Chapel Hill, North Carolina, 27599-7211
Study site
Chicago, Illinois, 60612
Study site
Chicago, Illinois, 60637
Study site
Cincinnati, Ohio, 45267
Study site
Dallas, Texas, 75235
Study site
Dallas, Texas, 75246
Study site
Denver, Colorado, 80262
Study site
Detroit, Michigan, 48202
Study site
Durham, North Carolina, 27710
Study site
Fairfax, Virginia, 22031
Study site
Gainesville, Florida, 32610-0224
Study site
Harrisburg, Pennsylvania, 17104
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46202
Study site
Jacksonville, Florida, 32216
Study site
Lexington, Kentucky, 40536
Study site
Livingston, New Jersey, 07039
Study site
Loma Linda, California, 92354
Study site
Los Angeles, California, 90033
Study site
Los Angeles, California, 90057
Study site
Los Angeles, California, 90058
Study site
Los Angeles, California, 90095-7306
Study site
Madison, Wisconsin, 53792-7375
Study site
Milwaukee, Wisconsin, 53226
Study site
Mobile, Alabama, 36617
Study site
Nashville, Tennessee, 37212-4750
Study site
New Brunswick, New Jersey, 08901
Study site
New Orleans, Louisiana, 70112
Study site
New Orleans, Louisiana, 70121
Study site
New York, New York, 10029
Study site
Palo Alto, California, 94304
Study site
Philadelphia, Pennsylvania, 19104
Study site
Philadelphia, Pennsylvania, 19107
Study site
Portland, Oregon, 97210
Study site
Portland, Oregon, 97239-2940
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78229-3900
Study site
San Diego, California, 92103
Study site
San Diego, California, 92123
Study site
San Francisco, California, 94115
Study site
Valhalla, New York, 10595
Study site
Washington D.C., District of Columbia, 20010
Brazil5 sites
Study site
Porto Alegre, 90240-520
Study site
Rio de Janeiro, 21041-003
Study site
São Paulo, 04013-043
Study site
São Paulo, 04038-002
Study site
São Paulo, 05465-040
Canada4 sites
Study site
Edmonton, Alberta
Study site
Montreal, Quebec
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
About this study
Official title: A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF, Modified Release (MR) Tacrolimus/MMF and Neoral (Cyclosporine)/MMF in de Novo Kidney Transplant Recipients
The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients.
Read the detailed description
This was a 3 arm randomized, open-label, comparative, multi-center study in de novo kidney transplant recipients at 60 centers in the U.S., Canada and Brazil.
The study consisted of a 1-year post-transplant efficacy and safety study with a clinical continuation phase of a minimum of 2 years or until commercial availability of tacrolimus modified release, unless the Data Safety Monitoring Board or sponsor specified otherwise.
- Conditions
- Kidney Transplantation
- Being tested
- Tacrolimus Modified Release (MR), Tacrolimus, cyclosporine microemulsion, mycophenolate mofetil
- Keywords
- De Novo Kidney Transplant, cyclosporine, Prograf®, mycophenolate mofetil, tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus Modified Release (MR)Drug
Also called Advagraf, FK506, FKMR, MR4, Astagraf XL
The target range for whole blood tacrolimus trough concentrations was 7 to 16 ng/mL for days 0 through 90, and 5 to 15 ng/mL thereafter.
TacrolimusDrug
Also called Prograf, FK506
The target range for whole blood tacrolimus trough concentrations was the recommended trough concentration range for Prograf: 7 to 16 ng/mL for days 0 through 90 and 5 to 15 ng/mL thereafter.
cyclosporine microemulsionDrug
Also called Neoral, CsA
The target range for whole blood cyclosporine trough concentrations was 125 to 400 ng/mL for days 0 through 90, and 100 to 300 ng/mL thereafter.
Also called CellCept, MMF
Oral
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus | Experimental | Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study. Receives: Drug: Tacrolimus; Drug: mycophenolate mofetil |
| Tacrolimus Modified Release | Active comparator | Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study. Receives: Drug: Tacrolimus Modified Release (MR); Drug: mycophenolate mofetil |
| Cyclosporine | Active comparator | Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study. Receives: Drug: cyclosporine microemulsion; Drug: mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Efficacy Failure
Efficacy failure is defined as any participant who died, experienced a graft failure (permanent return to dialysis [> 30 days] or retransplant), had a biopsy-confirmed (Banff Grade ≥ I) acute rejection (BCAR), or was lost to follow-up.
Biopsies were graded according to the 1997 Banff criteria:
Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.
Measured: one year
Secondary outcomes (14)
Patient Survival at One Year
Patient survival is defined as any participant who is known to be alive one year after the skin closure date. Participants who died or whose outcome was unknown at one year were considered to be non-survivors.
Measured: One year
Graft Survival at One Year
Graft survival defined as any participant who did not meet the criteria for graft loss, where graft loss is defined as any re-transplant, permanent return to dialysis (> 30 days), patient death, or participant whose outcome at one year was unknown.
Participants were only counted once regardless of how many criteria were met.
Measured: One year
Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria:
Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.
Acute rejection is defined as a grade ≥ I.
Measured: Six months and 12 months
Time to First Biopsy-confirmed Acute Rejection Episode
Time to first biopsy-confirmed acute rejection episode defined as the number of days from skin closure (Day 0) to the date of biopsy. Rejection episodes were confirmed by biopsy by the clinical site pathologist and graded according to the 1997 Banff criteria:
Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.
Acute rejection is defined as a grade ≥ I.
Measured: one year
Number of Participants Requiring Anti-lymphocyte Antibody Therapy for Treatment of Rejection
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Participants with histologically-proven Banff Grade II or III rejection or participants with steroid-resistant rejection were treated with anti-lymphocyte antibody treatment according to institutional practice.
Biopsies were graded according to the 1997 Banff criteria:
Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.
Measured: one year
Severity of Acute Rejection
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria:
Borderline: No intimal arteritis present but foci of mild tubulitis; Grade IA: Significant interstitial infiltration and foci of moderate tubulitis; Grade IB: Significant interstitial infiltration and foci of severe tubulitis; Grade IIA: Mild to moderate intimal arteritis in at least 1 arterial cross section Grade IIB: Severe intimal arteritis comprising >25% of the luminal area lost in at least 1 arterial cross section; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.
Measured: one year
Number of Participants Experiencing Multiple Rejection Episodes
This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.
Measured: one year
Number of Participants With Clinically Treated Acute Rejection Episodes
A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.
Measured: one year
Number of Participants With Treatment Failure
Treatment failure was defined as the discontinuation of randomized study drug for any reason. Participants who met the definition of treatment failure were to be followed throughout the 12-month treatment period.
Measured: one year
Number of Participants Who Crossed Over Due to Treatment Failure
Participants were allowed to cross over to an alternative primary immunosuppressive regimen (either to the tacrolimus or cyclosporine treatment arms) to address an adverse event which led to randomized study drug discontinuation or in the case of severe or refractory rejection. Crossover to the modified release tacrolimus treatment arm was not permitted.
Measured: one year
Change From Month 1 in Serum Creatinine at Month 6 and Month 12
Renal function was assessed by the change from Month 1 in serum creatinine six months and 12 months after transplant.
Measured: Month 1, Month 6, and Month 12
Change From Month 1 in Creatinine Clearance at Month 6 and Month 12
Renal function was assessed by creatinine clearance, calculated using the Cockcroft-Gault formula.
Measured: Month 1, Month 6, and Month 12
Kaplan-Meier Estimate of Patient Survival at the End of the Study
Patient survival was defined as any participant who was alive at the end of the study. Patient survival was censored at the time of last follow-up contact.
Measured: End of study (maximum time on study was 1,941 days).
Kaplan-Meier Estimate of Graft Survival at the End of the Study
Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was any retransplant or the permanent return to dialysis (more than 30 days) or patient death.
Graft survival was censored at the time of last follow-up contact.
Measured: End of study (maximum time on study was 1,941 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2003 (estimated)
- Study startJun 2003
- Primary completionMar 2005
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 668 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064701
- Sponsor's protocol ID
- 02-0-158
- Status last verified
- Nov 2013
- First submitted
- 10 Jul 2003
- Last updated
- 5 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Silva HT Jr, Yang HC, Abouljoud M, Kuo PC, Wisemandle K, Bhattacharya P, Dhadda S, Holman J, Fitzsimmons W, First MR. One-year results with extended-release tacrolimus/MMF, tacrolimus/MMF and cyclosporine/MMF in de novo kidney transplant recipients. Am J Transplant. 2007 Mar;7(3):595-608. doi: 10.1111/j.1600-6143.2007.01661.x. Epub 2007 Jan 11.
PubMed 17217442
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF, Modified Release (MR) Tacrolimus/MMF and Neoral (Cyclosporine)/MMF in de Novo Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT00064701
- Acronym / sponsor ID
- 02-0-158
- Conditions
- Kidney Transplantation
- Keywords
- De Novo Kidney Transplant, cyclosporine, Prograf®, mycophenolate mofetil, tacrolimus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Jul 2003 (estimated)
- Results
- Posted 26 Sep 2013
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 tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients.
Detailed description
This was a 3 arm randomized, open-label, comparative, multi-center study in de novo kidney transplant recipients at 60 centers in the U.S., Canada and Brazil.
The study consisted of a 1-year post-transplant efficacy and safety study with a clinical continuation phase of a minimum of 2 years or until commercial availability of tacrolimus modified release, unless the Data Safety Monitoring Board or sponsor specified otherwise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus | Experimental | Drug: Tacrolimus, Drug: mycophenolate mofetilParticipants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study. |
| Tacrolimus Modified Release | Active comparator | Drug: Tacrolimus Modified Release (MR), Drug: mycophenolate mofetilParticipants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study. |
| Cyclosporine | Active comparator | Drug: cyclosporine microemulsion, Drug: mycophenolate mofetilParticipants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Recipient of a primary or retransplanted non-human leukocyte antigen (HLA)-identical living or non-HLA-identical cadaveric kidney transplant
- Age greater or equal to 12 years
Key exclusion criteria (8 listed)
- Recipient or donor is known seropositive for human immunodeficiency virus (HIV)
- Has current malignancy or history of malignancy
- Has significant liver disease
- Has uncontrolled concomitant infection or any other unstable medical condition
- Is receiving everolimus or enteric coated mycophenolic acid at any time during the study
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 |
|---|---|---|
| Tacrolimus Modified Release (MR)Also: Advagraf, FK506, FKMR, MR4, Astagraf XLThe target range for whole blood tacrolimus trough concentrations was 7 to 16 ng/mL for days 0 through 90, and 5 to 15 ng/mL thereafter. | Drug | Tacrolimus Modified Release |
| TacrolimusAlso: Prograf, FK506The target range for whole blood tacrolimus trough concentrations was the recommended trough concentration range for Prograf: 7 to 16 ng/mL for days 0 through 90 and 5 to 15 ng/mL thereafter. | Drug | Tacrolimus |
| cyclosporine microemulsionAlso: Neoral, CsAThe target range for whole blood cyclosporine trough concentrations was 125 to 400 ng/mL for days 0 through 90, and 100 to 300 ng/mL thereafter. | Drug | Cyclosporine |
| mycophenolate mofetilAlso: CellCept, MMFOral | Drug | Cyclosporine, Tacrolimus, Tacrolimus Modified Release |
Primary outcome
Percentage of Participants With Efficacy Failure
Time frame: one year
Efficacy failure is defined as any participant who died, experienced a graft failure (permanent return to dialysis [> 30 days] or retransplant), had a biopsy-confirmed (Banff Grade ≥ I) acute rejection (BCAR), or was lost to follow-up. Biopsies were graded according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.
14 secondary outcomes
Patient Survival at One Year
Time frame: One year
Graft Survival at One Year
Time frame: One year
Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months
Time frame: Six months and 12 months
Time to First Biopsy-confirmed Acute Rejection Episode
Time frame: one year
Number of Participants Requiring Anti-lymphocyte Antibody Therapy for Treatment of Rejection
Time frame: one year
Severity of Acute Rejection
Time frame: one year
Number of Participants Experiencing Multiple Rejection Episodes
Time frame: one year
Number of Participants With Clinically Treated Acute Rejection Episodes
Time frame: one year
Number of Participants With Treatment Failure
Time frame: one year
Number of Participants Who Crossed Over Due to Treatment Failure
Time frame: one year
Change From Month 1 in Serum Creatinine at Month 6 and Month 12
Time frame: Month 1, Month 6, and Month 12
Change From Month 1 in Creatinine Clearance at Month 6 and Month 12
Time frame: Month 1, Month 6, and Month 12
Kaplan-Meier Estimate of Patient Survival at the End of the Study
Time frame: End of study (maximum time on study was 1,941 days).
Kaplan-Meier Estimate of Graft Survival at the End of the Study
Time frame: End of study (maximum time on study was 1,941 days).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17217442Silva HT Jr, Yang HC, Abouljoud M, Kuo PC, Wisemandle K, Bhattacharya P, Dhadda S, Holman J, Fitzsimmons W, First MR. One-year results with extended-release tacrolimus/MMF, tacrolimus/MMF and cyclosporine/MMF in de novo kidney transplant recipients. Am J Transplant. 2007 Mar;7(3):595-608. doi: 10.1111/j.1600-6143.2007.01661.x. Epub 2007 Jan 11.
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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.
Use Central Contact study director
Astellas Pharma Global Development
57 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacrolimus Modified Release (MR), Tacrolimus and cyclosporine microemulsion in people with Kidney Transplantation, run by Astellas Pharma Inc at 57 sites in 3 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 2 inclusion and 8 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 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Brazil, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 26 Sep 2013). 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 Efficacy Failure (time frame: one year). 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 NCT00064701, 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 5 Dec 2013.