Graft RejectionPhase 2NCT00035555
Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney
A Phase 2 study testing Belatacept, Cyclosporine and Mycophenolate mofetil (MMF) in people with Graft Rejection and Kidney Transplantation, run by Bristol-Myers Squibb at 12 sites in United States.
Trial summary
The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is as efficacious as treatment with cyclosporine at preventing acute rejection and with a superior safety/tolerability profile (better kidney function and blood pressure, fewer lipid problems, less diabetes mellitus). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Rejection, Kidney Transplantation, Renal Transplantation
- What is being tested?
- Belatacept, Cyclosporine and Mycophenolate mofetil (MMF)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2001to Jul 2012
- 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
- Recipients of first kidney transplant
Who cannot join
- Those at high risk for acute allograft rejection, including those who receive a second or more renal transplant, those with a history of panel reactive antibody levels >20%, and those considered by investigators to be at relatively higher risk for acute rejection
- Human leukocyte antigen-identical donor-recipient pairs
- Cold ischemia time >36 hours (donor kidney)
- Participants who are positive for hepatitis C antibody, on polymerase chain reaction, for hepatitis B surface antigen, and for human immunodeficiency virus
- A positive purified protein derivative tuberculosis test (test performed within 1 year of enrollment), unless previously vaccinated with Bacille-Calmette-Guérin or those who had a history of adequate chemoprophylaxis
- Any active infection that would normally exclude transplantation
Show all 19Show fewer
- Recipients of multiple organ transplants
- Donor age >60 or <6 years or donors whose hearts were not beating
- Recipients with underlying renal disease of (due to risk of rapid disease recurrence in the allograft): focal segmental glomerulosclerosis, Type I or II membranoproliferative glomerulonephritis, or hemolytic uremic syndrome/ thrombotic thrombocytopenic purpura
- A positive T-cell lymphocytoxic crossmatch using donor lymphocytes and recipient serum
- A history of true allergy to intravenous iodinated roentgenographic contrast agents
- Participants with life expectancy severely limited by disease state or other underlying medical condition
- A history of cancer (other than nonmelanoma skin cell cancers cured by local resection) within the last 5 years
- Mammogram film with any clinically significant abnormality requiring further investigation or biopsies
- History of substance abuse (drug or alcohol) or psychotic disorders that were not compatible with adequate study follow-up
- A currently functioning, nonrenal transplant
- Previous treatment with basiliximab for any reason
- Active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption
- Those who had used any investigational drug within 30 days before the Day 1 visit.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Emory Univ. School of Medicine
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical Univ. of South Carolina
Charleston, South Carolina, 29425
Baylor Univ. Medical Center
Dallas, Texas, 75246
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Univ. of Wisconsin
Madison, Wisconsin, 53792-7375
Mount Sinai Medical Center
New York, New York, 10029-6574
Univ. of Nebraska Medical Center
Omaha, Nebraska, 68198-1002
Univ. of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Univ. of Calif. - San Francisco
San Francisco, California, 94143-0001
About this study
Official title: Phase II/III, Open-Label, Randomized, Controlled, Multiple-Dose Study of Efficacy and Safety of BMS-224818 (Belatacept) as Part of a Quadruple Drug Regimen in First Renal Transplant Recipients
The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is as efficacious as treatment with cyclosporine at preventing acute rejection and with a superior safety/tolerability profile (better kidney function and blood pressure, fewer lipid problems, less diabetes mellitus).
- Being tested
- Belatacept, Cyclosporine, Mycophenolate mofetil (MMF), Corticosteroids
- Keywords
- kidney, transplant, rejection
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelataceptDrug
Also called LEA29Y, BMS-224818
Solution, intravenous
CyclosporineDrug
Also called The cyclosporine used in this study will be in the modified formulation with enhanced bioavailability.
Oral, capsule
Mycophenolate mofetil (MMF)Drug
Oral, capsule
CorticosteroidsDrug
Corticosteroids given daily, orally or intravenously (IV). Day of transplant (Day 1): methylprednisolone, 500 mg, given IV on arrival in operating room; Day 2: methylprednisolone, 250 mg, given IV once daily; Day 3: prednisone, 100 mg, given orally once daily; Day 4: prednisone, 50 mg, given orally once daily; Days 5 through 30: prednisone, 25 mg, given orally once daily; Days 31-44: prednisone, 22.5 mg, given orally once daily; Days 45-58: prednisone, 20 mg, given orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Belatacept: More intensive (MI) regimen | Experimental | The MI regimen was designed to achieve projected serum trough concentrations of belatacept of approximately 20 μg/mL through Day 99, and approximately 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141, and 169). After Day 169, patients were reallocated and dosed to achieve projected trough serum concentrations of approximately 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Those patients who received belatacept every 8 weeks received placebo infusions on scheduled treatment dates between infusions of active drug to maintain the blind between treatment regimens. Patients initially received mycophenolate mofetil (MMF), 2 g/d orally, unless the investigator chose to administer ≥1 doses intravenously The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the patient was able to tolerate medications by mouth. Corticosteroids given daily. Receives: Drug: Belatacept; Drug: Mycophenolate mofetil (MMF); Drug: Corticosteroids |
| Belatacept: Less intensive (LI) regimen | Experimental | The LI regimen was designed to achieve projected trough serum concentrations of belatacept of approximately 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either approximately 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally, unless the investigator chose to administer ≥1 doses intravenously The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. Corticosteroids given daily. Receives: Drug: Belatacept; Drug: Mycophenolate mofetil (MMF); Drug: Corticosteroids |
| Cyclosporine regimen | Experimental | The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally, unless the investigator chose to administer ≥1 doses intravenously The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. Corticosteroids given daily. Receives: Drug: Cyclosporine; Drug: Mycophenolate mofetil (MMF); Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR)
No participant was to receive treatment for acute rejection without a biopsy to confirm the diagnosis. CSPAR=Clinically-suspected rejection, defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function, and biopsy-proven rejection, which includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed.
Measured: By Month 6 posttransplant (From Day 1 to Month 6)
Secondary outcomes (9)
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12
BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed.
Measured: Through Months 6 and 12 posttransplant (From Day 1 to Months 6 and 12)
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection
BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed. A participant was reported as having had an episode of treated acute rejection if he or she received antirejection therapy during an episode of rejection (clinically-suspected or biopsy-proven rejection).
Measured: By Months 3, 6, and 12 posttransplant (Day 1 to Months 3, 6, and 12)
Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR)
Throughout this study, acute rejection=clinically-suspected and biopsy-proven acute rejection (BPAR). Clinically-suspected rejection is defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function. BPAR includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed. PAR is defined as an elevation in SCr ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function that led the investigator to suspect that the participant had experienced acute rejection, and in whom either the biopsy did not confirm acute rejection and the participant received treatment for acute rejection or the participant received treatment for acute rejection without a biopsy to confirm the diagnosis.
Measured: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Percentage of Participants Who Had Chronic Allograft Nephropathy
Based on postbaseline biopsies
Measured: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Mean Iohexol Clearance
Iohexol, a true glomerular filtration marker, is used to measure glomerular filtration rate.
Measured: By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)
Percentage of Participants Who Used Antihypertensive Medication
Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg
Measured: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Number of Participants With Hypertension
Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg or, the use of any antihypertensive medication.
Measured: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels
LDL=low-density lipoprotein; HDL=high-density lipoprotein. Total cholesterol=LDL + HDL + very low-density (VLDL) cholesterol. VLDL=triglycerides divided by 5. Non-HDL cholesterol=Total cholesterol minus HDL cholesterol.
Measured: By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)
Number of Participants With Posttransplant Diabetes Mellitus
Posttransplant diabetes mellitus is defined as the need for treatment of hyperglycemia with either an oral agent or insulin for a total of >4 weeks or hemoglobin A1c (HbA1c) >7% in a participant not known to be diabetic prior to transplantation
Measured: By Months 1, 3, 6, 9, and 12 posttransplant (Day 1 to Months 1, 3, 6, 9, and 12 )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study startMar 2001
- Primary completionJan 2004
- Study completionJul 2012
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 Graft RejectionStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035555
- Sponsor's protocol ID
- IM103-100
- Status last verified
- Nov 2013
- First submitted
- 3 May 2002
- Last updated
- 13 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III, Open-Label, Randomized, Controlled, Multiple-Dose Study of Efficacy and Safety of BMS-224818 (Belatacept) as Part of a Quadruple Drug Regimen in First Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00035555
- Acronym / sponsor ID
- IM103-100
- Keywords
- kidney, transplant, rejection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 6 May 2002 (estimated)
- Results
- Posted 13 Jan 2014
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 treatment with Belatacept (BMS-224818) is as efficacious as treatment with cyclosporine at preventing acute rejection and with a superior safety/tolerability profile (better kidney function and blood pressure, fewer lipid problems, less diabetes mellitus).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Belatacept: More intensive (MI) regimen | Experimental | Drug: Belatacept, Drug: Mycophenolate mofetil (MMF), Drug: CorticosteroidsThe MI regimen was designed to achieve projected serum trough concentrations of belatacept of approximately 20 μg/mL through Day 99, and approximately 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141, and 169). After Day 169, patients were reallocated and dosed to achieve projected trough serum concentrations of approximately 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Those patients who received belatacept every 8 weeks received placebo infusions on scheduled treatment dates between infusions of active drug to maintain the blind between treatment regimens. Patients initially received mycophenolate mofetil (MMF), 2 g/d orally, unless the investigator chose to administer ≥1 doses intravenously The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the patient was able to tolerate medications by mouth. Corticosteroids given daily. |
| Belatacept: Less intensive (LI) regimen | Experimental | Drug: Belatacept, Drug: Mycophenolate mofetil (MMF), Drug: CorticosteroidsThe LI regimen was designed to achieve projected trough serum concentrations of belatacept of approximately 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either approximately 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally, unless the investigator chose to administer ≥1 doses intravenously The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. Corticosteroids given daily. |
| Cyclosporine regimen | Experimental | Drug: Cyclosporine, Drug: Mycophenolate mofetil (MMF), Drug: CorticosteroidsThe initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally, unless the investigator chose to administer ≥1 doses intravenously The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. Corticosteroids given daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recipients of first kidney transplant
Key exclusion criteria (19 listed)
- Those at high risk for acute allograft rejection, including those who receive a second or more renal transplant, those with a history of panel reactive antibody levels >20%, and those considered by investigators to be at relatively higher risk for acute rejection
- Human leukocyte antigen-identical donor-recipient pairs
- Cold ischemia time >36 hours (donor kidney)
- Participants who are positive for hepatitis C antibody, on polymerase chain reaction, for hepatitis B surface antigen, and for human immunodeficiency virus
- A positive purified protein derivative tuberculosis test (test performed within 1 year of enrollment), unless previously vaccinated with Bacille-Calmette-Guérin or those who had a history of adequate chemoprophylaxis
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 |
|---|---|---|
| BelataceptAlso: LEA29Y, BMS-224818Solution, intravenous | Drug | Belatacept: Less intensive (LI) regimen, Belatacept: More intensive (MI) regimen |
| CyclosporineAlso: The cyclosporine used in this study will be in the modified formulation with enhanced bioavailability.Oral, capsule | Drug | Cyclosporine regimen |
| Mycophenolate mofetil (MMF)Oral, capsule | Drug | Belatacept: Less intensive (LI) regimen, Belatacept: More intensive (MI) regimen, Cyclosporine regimen |
| CorticosteroidsCorticosteroids given daily, orally or intravenously (IV). Day of transplant (Day 1): methylprednisolone, 500 mg, given IV on arrival in operating room; Day 2: methylprednisolone, 250 mg, given IV once daily; Day 3: prednisone, 100 mg, given orally once daily; Day 4: prednisone, 50 mg, given orally once daily; Days 5 through 30: prednisone, 25 mg, given orally once daily; Days 31-44: prednisone, 22.5 mg, given orally once daily; Days 45-58: prednisone, 20 mg, given orally once daily | Drug | Belatacept: Less intensive (LI) regimen, Belatacept: More intensive (MI) regimen, Cyclosporine regimen |
Primary outcome
Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR)
Time frame: By Month 6 posttransplant (From Day 1 to Month 6)
No participant was to receive treatment for acute rejection without a biopsy to confirm the diagnosis. CSPAR=Clinically-suspected rejection, defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function, and biopsy-proven rejection, which includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed.
9 secondary outcomes
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12
Time frame: Through Months 6 and 12 posttransplant (From Day 1 to Months 6 and 12)
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection
Time frame: By Months 3, 6, and 12 posttransplant (Day 1 to Months 3, 6, and 12)
Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR)
Time frame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Percentage of Participants Who Had Chronic Allograft Nephropathy
Time frame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Mean Iohexol Clearance
Time frame: By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)
Percentage of Participants Who Used Antihypertensive Medication
Time frame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Number of Participants With Hypertension
Time frame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels
Time frame: By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)
Number of Participants With Posttransplant Diabetes Mellitus
Time frame: By Months 1, 3, 6, 9, and 12 posttransplant (Day 1 to Months 1, 3, 6, 9, and 12 )
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
12 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 Belatacept, Cyclosporine and Mycophenolate mofetil (MMF) in people with Graft Rejection and Kidney Transplantation, run by Bristol-Myers Squibb at 12 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 19 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 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 13 Jan 2014). 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?
Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR) (time frame: By Month 6 posttransplant (From Day 1 to Month 6)). 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 13 Jan 2014.