Graft RejectionPhase 2NCT00771875
Randomized Trial for Mixed Acute Rejection
A Phase 2 study testing Rabbit Antithymocyte Globulin (RATG), Rituximab and Bortezomib in people with Graft Rejection, run by University of Cincinnati at 2 sites in United States.
Trial summary
This study is being conducted to determine how safe and effective using an immune cell (b cell) depleting therapy and/or Thymoglobulin is in patients with a kidney transplant who are experiencing certain types of rejection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graft Rejection
- What is being tested?
- Rabbit Antithymocyte Globulin (RATG), Rituximab and Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Mar 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each subject must meet all of the following inclusion criteria to be enrolled in the study:
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal or surgically sterilized or willing to use two acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
- Subject is between 18 and 65 years of age, inclusive.
- Subject has a transplant dysfunction indicated by an increase in creatinine of 0.3 mg/dL or 15% (lipase >3 X ULN for kidney/pancreas recipients) over baseline necessitating an allograft biopsy to assess for allograft rejection.
Show all 11Show fewer
- Presence of light microscopic histologic changes consistent with acute cellular rejection of a Banff 97 (2005 update) grade IA or greater and at least one of the following:
- Donor-specific antibody (DSA) positive via Luminex
- Presence of C4d in the peritubular capillaries or glomeruli
- Subject must have no known contraindications to treatment with bortezomib, boron or mannitol, thymoglobulin, or rituximab.
- Recipients of kidney or simultaneous kidney pancreas organ transplant.
Who cannot join
- Subjects meeting any of the following exclusion criteria are not to be enrolled in the study.
- Subject has a platelet count < 100,000/mm3 within 7 days before enrollment.
- Subject has an absolute neutrophil count of < 1,000/mm3 within 7 days before enrollment.
- Subject has Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Subject has received other investigational drugs with 14 days before enrollment
Show all 20Show fewer
- Serious medical (other than renal disease) or psychiatric illness likely to interfere with participation in this clinical study.
- Subjects that have previously received an organ transplant other than kidney or simultaneous kidney pancreas.
- Subjects who are recipients of A-B-O incompatible transplants, all cytotoxicity (CDC) crossmatch positive transplants
- Recipients of a simultaneous kidney pancreas transplant that only have pancreas rejection.
- Subjects unable to tolerate a dose of mycophenolate mofetil 1-3g/day (or equivalent mycophenolic acid dose).
- Subjects who are anti-HIV-positive, or HBsAg-positive. Anti-Hepatitis C Virus (HCV) positive patients are excluded, except patients with negative pathologic complete remission-result.
- Recipients of a kidney from a donor who tests positive for HIV, HBsAg or anti-HCV
- History of malignancy within the past 5 years that is not considered to be cured, with the exception of localized basal cell carcinoma of the skin (excised ≥ 2 years prior to randomization)
- Subjects with current or recent severe systemic infections within the 2 weeks prior to randomization.
- Receipt of a live vaccine within 4 weeks prior to study entry
- Evidence of severe liver disease with abnormal liver profile (aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin > 3 times upper limit of normal (ULN)) at screening.
- Pregnant or nursing (lactating) women.
- EBV sero-mismatch (EBV + donor organ transplanted to EBV - recipient)
- CMV sero-mismatch (CMV + donor organ transplanted to CMV - recipient)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Christ Hospital
Cincinnati, Ohio, 45202
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
About this study
Official title: B-Cell Targeted Therapy for Acute Renal Allograft Rejection With an Antibody Mediated Component: A Prospective, Randomized, Open-Label Study
This study is being conducted to determine how safe and effective using an immune cell (b cell) depleting therapy and/or Thymoglobulin is in patients with a kidney transplant who are experiencing certain types of rejection.
Read the detailed description
The purpose of the study is to determine safety and efficacy of treatment if mixed (cellular and antibody) mediated acute rejection with addition of B-cell depleting therapy to Thymoglobulin in kidney and simultaneous kidney pancreas allograft recipients.
- Conditions
- Graft Rejection
- Being tested
- Rabbit Antithymocyte Globulin (RATG), Rituximab, Bortezomib, Acetaminophen, Antihistamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabbit Antithymocyte Globulin (RATG)Drug
Also called thymoglobulin
All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
RituximabDrug
Also called rituxan
Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
BortezomibDrug
Also called Velcade
Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
AcetaminophenDrug
Also called Tylenol
Patients will be premedicated with acetaminophen prior to dosing per institution standard of care.
AntihistamineDrug
Also called diphenhydramine
Patients will be premedicated with an antihistamine prior to dosing per institution standard of care.
Also called Medrol
Methylprednisolone 250 mg with 1st dose of Thymoglobulin. Methylprednisolone 125 mg on treatment day 2 subsequent corticosteroids per institution standard of care; following treatment, corticosteroid therapy will resume at the pre-rejection dose.
| Study group | Role | What they receive |
|---|---|---|
| Rabbit Antithymocyte Globulin (RATG) | Active comparator | Rabbit Antithymocyte Globulin (RATG) All patients will receive RATG (Thymoglobulin) dosed based on CD3 count. Patients will be redosed when the cluster of differentiation 3 (CD3) count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily. 1.5mg/kg/day over 6 hrs with 1st dose (D1) and over 4 hours for each dose thereafter. (day 1 then when CD3 levels > 25 cells/mm3); Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care. Methylprednisolone 250 mg with 1st dose of Thymoglobulin. Methylprednisolone 125 mg on treatment day 2 subsequent corticosteroids per institution standard of care; following treatment, corticosteroid therapy will resume at the pre-rejection dose. Receives: Drug: Rabbit Antithymocyte Globulin (RATG); Drug: Rituximab; Drug: Bortezomib; Drug: Acetaminophen; Drug: Antihistamine; Drug: Methylprednisolone |
| RATG/Rituximab | Experimental | Rabbit Antithymocyte Globulin (RATG) + Rituximab Subjects will be given 1.5mg/kg/day of RATG over 6 hrs with 1st dose (D1) and over 4 hours for each dose thereafter. (day 1 then when CD3 levels > 25 cells/mm3); Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care. Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care. Methylprednisolone 250 mg with 1st dose of Thymoglobulin. Methylprednisolone 125 mg on treatment day 2 subsequent corticosteroids per institution standard of care; following treatment, corticosteroid therapy will resume at the pre-rejection dose. Receives: Drug: Rituximab; Drug: Acetaminophen; Drug: Antihistamine; Drug: Methylprednisolone |
| RATG/Bortezomib | Experimental | Rabbit Antithymocyte Globulin (RATG) + Bortezomib -Subjects will be given 1.5mg/kg/day of RATG over 6 hrs with 1st dose (D1) and over 4 hours for each dose thereafter. (day 1 then when CD3 levels > 25 cells/mm3). Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care. Bortezomib will be given at a dose of 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Methylprednisolone will be administered prior to each bortezomib dose. On days 2 and 5, administer methylprednisolone 100 mg intravenous push (IVP). On days 9 and 12, administer methylprednisolone 50 mg intravenous push (IVP). If thymoglobulin is administered the same day as bortezomib, the order of administration is- methylprednisolone, then bortezomib, then thymoglobulin. Receives: Drug: Bortezomib; Drug: Acetaminophen; Drug: Antihistamine; Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection
Rejection Reversal is a return of serum creatinine to within 115% of the baseline value, or histologic reversal occurring within 14 days of initiation of treatment.
Recurrent Rejection is histologic evidence of rejection noted on a biopsy specimen obtained up to 3 months after documented rejection reversal.
Measured: 1 year
Secondary outcomes (6)
Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy
Measured: Day 1
Renal Allograft Survival
Measured: 1 year after rejection treatment
Mean Serum Creatinine
Renal allograft function as determined by change (∆) in Calculated creatinine clearance by Cockcroft-Gault at 7, 14, 28, 60, and 90 days and 1 year post therapy initiation
Measured: 7, 14, 28, 60, 90 days and 1 year post therapy initiation
Incidence of Death
Measured: 90 days
Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy
Measured: 90 days
Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2012
- Study completionMar 2013
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.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E. Steve Woodle, University of Cincinnati
- Investigators
- E. Steve Woodle, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771875
- Sponsor's protocol ID
- X05273
- Status last verified
- Dec 2015
- First submitted
- 14 Oct 2008
- Last updated
- 27 Jan 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 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-Cell Targeted Therapy for Acute Renal Allograft Rejection With an Antibody Mediated Component: A Prospective, Randomized, Open-Label Study
- ClinicalTrials.gov ID
- NCT00771875
- Acronym / sponsor ID
- X05273
- Conditions
- Graft Rejection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Posted 27 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to determine how safe and effective using an immune cell (b cell) depleting therapy and/or Thymoglobulin is in patients with a kidney transplant who are experiencing certain types of rejection.
Detailed description
The purpose of the study is to determine safety and efficacy of treatment if mixed (cellular and antibody) mediated acute rejection with addition of B-cell depleting therapy to Thymoglobulin in kidney and simultaneous kidney pancreas allograft recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rabbit Antithymocyte Globulin (RATG) | Active comparator | Drug: Rabbit Antithymocyte Globulin (RATG), Drug: Rituximab, Drug: Bortezomib, Drug: Acetaminophen, Drug: Antihistamine, Drug: MethylprednisoloneRabbit Antithymocyte Globulin (RATG) All patients will receive RATG (Thymoglobulin) dosed based on CD3 count. Patients will be redosed when the cluster of differentiation 3 (CD3) count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily. 1.5mg/kg/day over 6 hrs with 1st dose (D1) and over 4 hours for each dose thereafter. (day 1 then when CD3 levels > 25 cells/mm3); Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care. Methylprednisolone 250 mg with 1st dose of Thymoglobulin. Methylprednisolone 125 mg on treatment day 2 subsequent corticosteroids per institution standard of care; following treatment, corticosteroid therapy will resume at the pre-rejection dose. |
| RATG/Rituximab | Experimental | Drug: Rituximab, Drug: Acetaminophen, Drug: Antihistamine, Drug: MethylprednisoloneRabbit Antithymocyte Globulin (RATG) + Rituximab Subjects will be given 1.5mg/kg/day of RATG over 6 hrs with 1st dose (D1) and over 4 hours for each dose thereafter. (day 1 then when CD3 levels > 25 cells/mm3); Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care. Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care. Methylprednisolone 250 mg with 1st dose of Thymoglobulin. Methylprednisolone 125 mg on treatment day 2 subsequent corticosteroids per institution standard of care; following treatment, corticosteroid therapy will resume at the pre-rejection dose. |
| RATG/Bortezomib | Experimental | Drug: Bortezomib, Drug: Acetaminophen, Drug: Antihistamine, Drug: MethylprednisoloneRabbit Antithymocyte Globulin (RATG) + Bortezomib -Subjects will be given 1.5mg/kg/day of RATG over 6 hrs with 1st dose (D1) and over 4 hours for each dose thereafter. (day 1 then when CD3 levels > 25 cells/mm3). Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care. Bortezomib will be given at a dose of 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Methylprednisolone will be administered prior to each bortezomib dose. On days 2 and 5, administer methylprednisolone 100 mg intravenous push (IVP). On days 9 and 12, administer methylprednisolone 50 mg intravenous push (IVP). If thymoglobulin is administered the same day as bortezomib, the order of administration is- methylprednisolone, then bortezomib, then thymoglobulin. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Each subject must meet all of the following inclusion criteria to be enrolled in the study:
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal or surgically sterilized or willing to use two acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
- Subject is between 18 and 65 years of age, inclusive.
Key exclusion criteria (20 listed)
- Subjects meeting any of the following exclusion criteria are not to be enrolled in the study.
- Subject has a platelet count < 100,000/mm3 within 7 days before enrollment.
- Subject has an absolute neutrophil count of < 1,000/mm3 within 7 days before enrollment.
- Subject has Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
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 |
|---|---|---|
| Rabbit Antithymocyte Globulin (RATG)Also: thymoglobulinAll patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily. | Drug | Rabbit Antithymocyte Globulin (RATG) |
| RituximabAlso: rituxanRituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care. | Drug | RATG/Rituximab, Rabbit Antithymocyte Globulin (RATG) |
| BortezomibAlso: VelcadePatient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10. | Drug | RATG/Bortezomib, Rabbit Antithymocyte Globulin (RATG) |
| AcetaminophenAlso: TylenolPatients will be premedicated with acetaminophen prior to dosing per institution standard of care. | Drug | RATG/Bortezomib, RATG/Rituximab, Rabbit Antithymocyte Globulin (RATG) |
| AntihistamineAlso: diphenhydraminePatients will be premedicated with an antihistamine prior to dosing per institution standard of care. | Drug | RATG/Bortezomib, RATG/Rituximab, Rabbit Antithymocyte Globulin (RATG) |
| MethylprednisoloneAlso: MedrolMethylprednisolone 250 mg with 1st dose of Thymoglobulin. Methylprednisolone 125 mg on treatment day 2 subsequent corticosteroids per institution standard of care; following treatment, corticosteroid therapy will resume at the pre-rejection dose. | Drug | RATG/Bortezomib, RATG/Rituximab, Rabbit Antithymocyte Globulin (RATG) |
Primary outcome
Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection
Time frame: 1 year
Rejection Reversal is a return of serum creatinine to within 115% of the baseline value, or histologic reversal occurring within 14 days of initiation of treatment. Recurrent Rejection is histologic evidence of rejection noted on a biopsy specimen obtained up to 3 months after documented rejection reversal.
6 secondary outcomes
Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy
Time frame: Day 1
Renal Allograft Survival
Time frame: 1 year after rejection treatment
Mean Serum Creatinine
Time frame: 7, 14, 28, 60, 90 days and 1 year post therapy initiation
Incidence of Death
Time frame: 90 days
Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy
Time frame: 90 days
Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Graft Rejection
RecruitingPhase 1
Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
Kidney Transplant Rejection
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Recruiting
Efficiency of Everolimus for the Treatment of Kidney Transplanted Patients Presenting a Missing Self-induced NK-mediated Rejection
Kidney Transplant Failure and Rejection
RecruitingObservational study
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Heart Failure, Liver Fibrosis
Active, not recruitingObservational study
Australian Genomics Of Chronic Allograft Dysfunction Study
Kidney Transplant Rejection, Kidney Transplant; Complications
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.
E. Steve Woodle, MD principal investigator
University of Cincinnati
2 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 Rabbit Antithymocyte Globulin (RATG), Rituximab and Bortezomib in people with Graft Rejection, run by University of Cincinnati at 2 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 11 inclusion and 20 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 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 27 Jan 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?
Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection (time frame: 1 year). 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 27 Jan 2016.