Diabetes MellitusPhase 1NCT00708604
Islet After Kidney Transplantation (IAK) in Patients With Type 1 Diabetes
A Phase 1 study testing Islet Transplantation and Islet cell transplantation in people with Diabetes Mellitus, run by City of Hope Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety of islet transplantation in patients with type 1 diabetes who have had a successful kidney transplant and have been maintained for at least three months on anti-rejection medications consisting of any combination of sirolimus, tacrolimus, MMF or prednisone (5 mg/day… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Islet Transplantation and Islet cell transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2008to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Type 1 diabetes mellitus. Documentation of negative basal and stimulated C-peptide (a basal level of </= 0.2 ng/ml before IV administration of 1 mg of glucagon, and a glucagon stimulated C-peptide </= 0.8 ng/ml) and diagnosis of diabetes for at least 5 years.
- Recipient of renal transplant with good function (serum creatinine </= 1.6 mg/dl, creatinine clearance >/=60 ml/min and albumin excretion </= 300 mg/24 hr) for >3 months.
- Stable immunosuppression consisting of any combination of sirolimus, tacrolimus, MMF or </= 5 mg/day of corticosteroids for at least 3 months, without major complications.
- No history of acute rejection episodes related to renal graft in last 12 months and low risk for developing acute rejection (first renal transplant, PRA <25%, negative kidney crossmatch by B, T, flow cytometry)
- Under the continuing care of a renal transplant nephrologist/surgeon.
- No evidence of liver disease (liver enzymes < twice the upper limit of normal for each of ALT and AST, bilirubin < 2 mg/dl, albumin > 3.5 g/dl, and PT and PTT </= 1.1 x the upper limit of normal).
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- Ability to comply with post-transplant regimen, including immunosuppression, insulin pump therapy and metabolic testing. Patients will be required to perform self-monitoring of blood glucose a minimum of four times daily, and provide complete records of blood glucose levels and insulin doses.
- Ability to give informed consent.
- Age greater than or equal to 18 years or less than or equal to 65 years.
- Subjects that have always been managed on a sirolimus/tacrolimus/MMF/low-dose corticosteroid (</=5mg) immunosuppressive regimen and never required conversion must provide a signed letter from their transplant nephrologist /surgeon documenting this.
- Subjects converted to a sirolimus/tacrolimus/MMF/low-dose corticosteroid immunosuppressive regimen, must provide proof of informed consent regarding immunosuppressive conversion in one of the following formats.
- Subjects that converted to sirolimus/tacrolimus/MMF/low-dose corticosteroids (</=5mg) due to best patient care (not to qualify for islet transplantation) must provide a signed letter from their transplant nephrologists/surgeon indicating the medical reason(s) for immunosuppression conversion (with the date indicated).
- Subjects that converted to a sirolimus/tacrolimus/MMF/low-dose corticosteroid (</=5mg) immunosuppressive regimen for the purpose of qualifying for islet transplantation must provide a signed immunosuppression conversion consent form.
Who cannot join
- Poor renal allograft function (serum creatinine > 1.6 mg/dl, creatinine clearance < 60ml/min, albumin excretion >300 mg/24hr)
- History of acute rejection related to renal graft in last 12 months or "high risk" for acute rejection (more than one previous renal transplant, PRA >25%, positive kidney crossmatch by B, T, flow cytometry)
- Current immunosuppression therapy with corticosteroids >5mg/day.
- Significant liver disease (including elevation of liver enzymes > twice the upper limit of normal for each of ALT and AST, bilirubin > 2 mg/dl, albumin < 3.5 g/dl, liver masses including portal vein thrombosis, evidence of portal hypertension, or significant, untreated gallbladder disease (i.e., gallstones).
- Significant cardiovascular disease, including non-correctable coronary artery disease with ejection fraction < 50% and/or recent myocardial infarction (within last 12 months); extensive peripheral vascular disease not correctable by surgery or untreated proliferative retinopathy.
- Recent unresolved acute infection, or chronic infection, including tuberculosis, HIV, HBV, HCV, CMV or positive skin test for TB.
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- Any history of malignancy, except squamous or basal skin cancer or in situ cancer of the cervix.
- Recent history of non-compliance, or inability to demonstrate capacity to comply with strict blood glycemic control and insulin pump therapy.
- Psychiatric illness that is untreated, or likely to interfere significantly with transplantation despite treatment.
- Presence of preformed antibodies on panel reactive antibody screening > 25%.
- Body mass index (BMI) greater than 30.
- Age less than 18 years or greater than 65 years.
- Presence of a chronic disease that must be chronically treated with one or more of the following medications: glucocorticoids, diazoxide, bumetanide, haloperidol, chlorpromazine, desipramine, doxepin, imipramine, levodopa, morphine, L-asparaginase, cyclophosphamide, isoniazid, heparin, nalidixic acid, or any other agents that may adversely influence glycemic control and which may confound the interpretation of Graft Success post-transplant.
- Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures for the duration of immunosuppressive therapy, and women presently breast feeding are ineligible due to the unknown effects of these drugs on the fetus and nursing infant.
- Active alcohol or substance abuse, including cigarette smoking (must be abstinent for > 3 months).
- Hyperlipidemia (total cholesterol > 260 mg/dl, LDL > 130 mg/dl, and/or triglycerides > 300 mg/dl) despite appropriate treatment.
- Anemia (Hgb < 12 g/dl) or other hematologic disorders that require medical attention.
- Increased risk of bleeding (platelet count < 80,000; INR > 1.5), other chronic hemostasis disorders, or treatment with chronic anticoagulant therapy (i.e., heparin or warfarin).
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Islet After Kidney Transplantation (IAK) in Patients With Type 1 Diabetes Using a Sirolimus/Tacrolimus/MMF-Based Immunosuppressive Regimen
The purpose of this study is to determine the safety of islet transplantation in patients with type 1 diabetes who have had a successful kidney transplant and have been maintained for at least three months on anti-rejection medications consisting of any combination of sirolimus, tacrolimus, MMF or prednisone (5 mg/day or less). Another purpose is to determine the effectiveness of an islet transplant in inducing insulin independence and whether or not an islet transplant improves quality of life for kidney transplants patients with type 1 diabetes.
Read the detailed description
Insulin is a hormone that helps the body use sugar and keeps blood sugar levels normal. Special cells in the human body, called beta cells, make insulin. Beta cells are found inside small groups of cells called "islets." Islets are found scattered in the pancreas gland. Type 1 diabetes is caused by damage to these insulin-making cells. Type 1 diabetic patients need insulin shots because their body does not make enough insulin. Even with insulin shots, many diabetic patients develop damage to the heart, blood vessels, nerves, eyes and kidneys. Research studies suggest that these problems are caused by blood sugar levels being too high.
Another way to treat diabetes is by giving the patient a pancreas transplant. The pancreas transplant gives the patient new insulin-making cells. If the pancreas transplant works, the patient does not need insulin shots. Pancreas transplantation is considered major surgery, and things can go wrong after surgery. Transplantation of just the islets, and not the rest of the pancreas, can be done without a major surgery. Research doctors have been studying islet transplantation to determine whether subjects who undergo the procedure can get off insulin shots, without the dangers of a major surgery.
In 2000, a group of research doctors in Edmonton, Canada reported that 3 out of 4 research subjects given islet transplants from brain-dead donors did not need insulin shots for approximately 2 years after transplantation. The research doctors from Edmonton have also reported that most islet transplant recipients in their study start to need insulin shots again with longer follow-up. So far, only about 1 out of 10 of the research subjects in the original Edmonton trial remain off of insulin 5 years after their transplant. The reasons that islet transplants stop working well enough and the recipients need to start insulin again are not known at this time. As with any type of transplant, all of the research subjects receiving islets from donors needed medicine to stop their bodies from rejecting the transplants. This study uses a few additional medications/vitamins that were not included in the Edmonton study that may improve the long-term outcome of islet transplantation. Some research studies suggest that for subjects with type 1 diabetes, an islet transplant may also help the kidney transplant work better and last longer.
This study is being performed to confirm that islet after kidney transplantation (IAK) is a safe and effective procedure for kidney transplant patients with type 1 diabetes who are on any combination of sirolimus, tacrolimus, MMF or prednisone (5 mg per day or less) anti-rejection medications for the care of their kidney transplant. Subjects will be followed closely for two years after islet transplant to monitor blood sugar control, the health of the kidney transplant, and changes in quality of life.
- Conditions
- Diabetes Mellitus
- Being tested
- Islet Transplantation, Islet cell transplantation
- Keywords
- Diabetes Mellitus, Kidney Transplantation, Islet Transplantation, Sirolimus/Tacrolimus/MMF-based Immunosuppressive Regimen
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Islet TransplantationProcedure or surgery
Islet Transplantation
Islet cell transplantationBiological
Islet cell transplantation will occur through the portal vein.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Islet transplantation Receives: Procedure: Islet Transplantation; Biological: Islet cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects who have achieved insulin sufficiency post transplant.
Measured: 3, 6, 12, and 24 months
Secondary outcomes (4)
Stimulated C-peptide response >0.6 ng/ml
Measured: 3, 6, 12, and 24 months
Insulin use </= 0.2 units/kg/day
Measured: 3, 6, 12, and 24 months
Reduction/elimination of hypoglycemic episodes
Measured: 3, 6, 12, and 24 months
HgAlc</= 6.5%
Measured: 3, 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study start18 Oct 2008
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fouad Kandeel, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708604
- Sponsor's protocol ID
- 04033
- Other IDs
- DK56952
- Status last verified
- Jul 2014
- First submitted
- 30 Jun 2008
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shapiro AM, Lakey JR, Ryan EA, Korbutt GS, Toth E, Warnock GL, Kneteman NM, Rajotte RV. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med. 2000 Jul 27;343(4):230-8. doi: 10.1056/NEJM200007273430401.
PubMed 10911004Ryan EA, Paty BW, Senior PA, Bigam D, Alfadhli E, Kneteman NM, Lakey JR, Shapiro AM. Five-year follow-up after clinical islet transplantation. Diabetes. 2005 Jul;54(7):2060-9. doi: 10.2337/diabetes.54.7.2060.
PubMed 15983207Fiorina P, Folli F, Maffi P, Placidi C, Venturini M, Finzi G, Bertuzzi F, Davalli A, D'Angelo A, Socci C, Gremizzi C, Orsenigo E, La Rosa S, Ponzoni M, Cardillo M, Scalamogna M, Del Maschio A, Capella C, Di Carlo V, Secchi A. Islet transplantation improves vascular diabetic complications in patients with diabetes who underwent kidney transplantation: a comparison between kidney-pancreas and kidney-alone transplantation. Transplantation. 2003 Apr 27;75(8):1296-301. doi: 10.1097/01.TP.0000061788.32639.D9.
PubMed 12717219Fiorina P, Folli F, Zerbini G, Maffi P, Gremizzi C, Di Carlo V, Socci C, Bertuzzi F, Kashgarian M, Secchi A. Islet transplantation is associated with improvement of renal function among uremic patients with type I diabetes mellitus and kidney transplants. J Am Soc Nephrol. 2003 Aug;14(8):2150-8. doi: 10.1097/01.asn.0000077339.20759.a3.
PubMed 12874470
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Islet After Kidney Transplantation (IAK) in Patients With Type 1 Diabetes Using a Sirolimus/Tacrolimus/MMF-Based Immunosuppressive Regimen
- ClinicalTrials.gov ID
- NCT00708604
- Acronym / sponsor ID
- 04033
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Kidney Transplantation, Islet Transplantation, Sirolimus/Tacrolimus/MMF-based Immunosuppressive Regimen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Oct 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Jul 2008 (estimated)
- Results
- Not posted in the source record
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 the safety of islet transplantation in patients with type 1 diabetes who have had a successful kidney transplant and have been maintained for at least three months on anti-rejection medications consisting of any combination of sirolimus, tacrolimus, MMF or prednisone (5 mg/day or less). Another purpose is to determine the effectiveness of an islet transplant in inducing insulin independence and whether or not an islet transplant improves quality of life for kidney transplants patients with type 1 diabetes.
Detailed description
Insulin is a hormone that helps the body use sugar and keeps blood sugar levels normal. Special cells in the human body, called beta cells, make insulin. Beta cells are found inside small groups of cells called "islets." Islets are found scattered in the pancreas gland. Type 1 diabetes is caused by damage to these insulin-making cells. Type 1 diabetic patients need insulin shots because their body does not make enough insulin. Even with insulin shots, many diabetic patients develop damage to the heart, blood vessels, nerves, eyes and kidneys. Research studies suggest that these problems are caused by blood sugar levels being too high.
Another way to treat diabetes is by giving the patient a pancreas transplant. The pancreas transplant gives the patient new insulin-making cells. If the pancreas transplant works, the patient does not need insulin shots. Pancreas transplantation is considered major surgery, and things can go wrong after surgery. Transplantation of just the islets, and not the rest of the pancreas, can be done without a major surgery. Research doctors have been studying islet transplantation to determine whether subjects who undergo the procedure can get off insulin shots, without the dangers of a major surgery.
In 2000, a group of research doctors in Edmonton, Canada reported that 3 out of 4 research subjects given islet transplants from brain-dead donors did not need insulin shots for approximately 2 years after transplantation. The research doctors from Edmonton have also reported that most islet transplant recipients in their study start to need insulin shots again with longer follow-up. So far, only about 1 out of 10 of the research subjects in the original Edmonton trial remain off of insulin 5 years after their transplant. The reasons that islet transplants stop working well enough and the recipients need to start insulin again are not known at this time. As with any type of transplant, all of the research subjects receiving islets from donors needed medicine to stop their bodies from rejecting the transplants. This study uses a few additional medications/vitamins that were not included in the Edmonton study that may improve the long-term outcome of islet transplantation. Some research studies suggest that for subjects with type 1 diabetes, an islet transplant may also help the kidney transplant work better and last longer.
This study is being performed to confirm that islet after kidney transplantation (IAK) is a safe and effective procedure for kidney transplant patients with type 1 diabetes who are on any combination of sirolimus, tacrolimus, MMF or prednisone (5 mg per day or less) anti-rejection medications for the care of their kidney transplant. Subjects will be followed closely for two years after islet transplant to monitor blood sugar control, the health of the kidney transplant, and changes in quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Islet Transplantation, Biological: Islet cell transplantationIslet transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Type 1 diabetes mellitus. Documentation of negative basal and stimulated C-peptide (a basal level of </= 0.2 ng/ml before IV administration of 1 mg of glucagon, and a glucagon stimulated C-peptide </= 0.8 ng/ml) and diagnosis of diabetes for at least 5 years.
- Recipient of renal transplant with good function (serum creatinine </= 1.6 mg/dl, creatinine clearance >/=60 ml/min and albumin excretion </= 300 mg/24 hr) for >3 months.
- Stable immunosuppression consisting of any combination of sirolimus, tacrolimus, MMF or </= 5 mg/day of corticosteroids for at least 3 months, without major complications.
- No history of acute rejection episodes related to renal graft in last 12 months and low risk for developing acute rejection (first renal transplant, PRA <25%, negative kidney crossmatch by B, T, flow cytometry)
- Under the continuing care of a renal transplant nephrologist/surgeon.
Key exclusion criteria (18 listed)
- Poor renal allograft function (serum creatinine > 1.6 mg/dl, creatinine clearance < 60ml/min, albumin excretion >300 mg/24hr)
- History of acute rejection related to renal graft in last 12 months or "high risk" for acute rejection (more than one previous renal transplant, PRA >25%, positive kidney crossmatch by B, T, flow cytometry)
- Current immunosuppression therapy with corticosteroids >5mg/day.
- Significant liver disease (including elevation of liver enzymes > twice the upper limit of normal for each of ALT and AST, bilirubin > 2 mg/dl, albumin < 3.5 g/dl, liver masses including portal vein thrombosis, evidence of portal hypertension, or significant, untreated gallbladder disease (i.e., gallstones).
- Significant cardiovascular disease, including non-correctable coronary artery disease with ejection fraction < 50% and/or recent myocardial infarction (within last 12 months); extensive peripheral vascular disease not correctable by surgery or untreated proliferative retinopathy.
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 |
|---|---|---|
| Islet TransplantationIslet Transplantation | Procedure or surgery | 1 |
| Islet cell transplantationIslet cell transplantation will occur through the portal vein. | Biological | 1 |
Primary outcome
Percent of subjects who have achieved insulin sufficiency post transplant.
Time frame: 3, 6, 12, and 24 months
4 secondary outcomes
Stimulated C-peptide response >0.6 ng/ml
Time frame: 3, 6, 12, and 24 months
Insulin use </= 0.2 units/kg/day
Time frame: 3, 6, 12, and 24 months
Reduction/elimination of hypoglycemic episodes
Time frame: 3, 6, 12, and 24 months
HgAlc</= 6.5%
Time frame: 3, 6, 12, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 10911004Shapiro AM, Lakey JR, Ryan EA, Korbutt GS, Toth E, Warnock GL, Kneteman NM, Rajotte RV. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med. 2000 Jul 27;343(4):230-8. doi: 10.1056/NEJM200007273430401.
- Background: PubMed 15983207Ryan EA, Paty BW, Senior PA, Bigam D, Alfadhli E, Kneteman NM, Lakey JR, Shapiro AM. Five-year follow-up after clinical islet transplantation. Diabetes. 2005 Jul;54(7):2060-9. doi: 10.2337/diabetes.54.7.2060.
- Background: PubMed 12717219Fiorina P, Folli F, Maffi P, Placidi C, Venturini M, Finzi G, Bertuzzi F, Davalli A, D'Angelo A, Socci C, Gremizzi C, Orsenigo E, La Rosa S, Ponzoni M, Cardillo M, Scalamogna M, Del Maschio A, Capella C, Di Carlo V, Secchi A. Islet transplantation improves vascular diabetic complications in patients with diabetes who underwent kidney transplantation: a comparison between kidney-pancreas and kidney-alone transplantation. Transplantation. 2003 Apr 27;75(8):1296-301. doi: 10.1097/01.TP.0000061788.32639.D9.
- Background: PubMed 12874470Fiorina P, Folli F, Zerbini G, Maffi P, Gremizzi C, Di Carlo V, Socci C, Bertuzzi F, Kashgarian M, Secchi A. Islet transplantation is associated with improvement of renal function among uremic patients with type I diabetes mellitus and kidney transplants. J Am Soc Nephrol. 2003 Aug;14(8):2150-8. doi: 10.1097/01.asn.0000077339.20759.a3.
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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.
Fouad Kandeel, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Islet Transplantation and Islet cell transplantation in people with Diabetes Mellitus, run by City of Hope Medical Center at 1 site 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 13 inclusion and 18 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 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of subjects who have achieved insulin sufficiency post transplant. (time frame: 3, 6, 12, and 24 months). 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 NCT00708604, which also lists 4 linked publications.
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 Apr 2026.