Your session is about to expire
← Back to Search
Immunosuppressant
Low-Dose ATG for Type 1 Diabetes (TN28 Trial)
Phase 2
Recruiting
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants are required to receive non-live influenza vaccination at least 2 weeks prior to randomization when vaccine for the current or upcoming flu season is available
Be up to date on all recommended vaccinations based on age of subject* With the exception of stage 2 T1D, subjects must be healthy, as defined by absence of any other untreated diagnoses that the protocol committee deems to be a potential confounder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
TN28 Trial Summary
This trialtests if a drug can help prevent Type 1 diabetes from getting worse in people at risk.
Who is the study for?
This trial is for people aged 12-35 with a high risk of developing stage 3 Type 1 Diabetes, as indicated by specific blood markers. They must be healthy, not pregnant, willing to avoid live vaccines and comply with COVID-19 safety measures. Participants cannot have certain infections or immune conditions.Check my eligibility
What is being tested?
The study tests if low-dose Antithymocyte Globulin (ATG) can prevent progression to stage 3 Type 1 Diabetes compared to a placebo. It's double-blind and participants are randomly assigned in a ratio of two ATG recipients for every one placebo recipient.See study design
What are the potential side effects?
Potential side effects include allergic reactions to the medication, which is derived from rabbits. There may also be risks associated with immunosuppression such as increased susceptibility to infections.
TN28 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received or will receive the flu shot at least 2 weeks before joining the study.
Select...
I am up to date on vaccinations and have no untreated health issues.
Select...
I am between 12 and 34 years old.
Select...
I meet the criteria for early-stage diabetes and have high-risk markers.
Select...
I have diabetes with two or more specific autoantibodies present.
Select...
I meet the criteria for early-stage diabetes and have high-risk markers.
Select...
It has been over 4 weeks since my last live vaccine.
Select...
I am an adult fully vaccinated or a child on track with vaccinations per AAP guidelines.
Select...
I agree not to get any vaccines, except for the flu shot, for 3 months after the study drug treatment.
Select...
My BMI is within the healthy range for my age.
Select...
I am fully vaccinated against COVID-19, including boosters, and tested negative recently.
Select...
My blood pressure is below 130/80 mmHg if I'm 18 or older, or below the 95th percentile for my age, sex, and height if I'm younger.
Select...
I have tested negative for CMV and EBV in the last 30 days and haven't had symptoms of these viruses for more than 7 days.
Select...
I am willing to give my consent, or my guardian will if I'm under 18.
Select...
I live or can stay close to the treatment center and a hospital for 3 days during my treatment.
Select...
My weight is above the 5th percentile for my age and sex.
TN28 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression to Stage 3 T1D
Side effects data
From 2016 Phase 2 trial • 52 Patients • NCT0038578892%
Nausea
75%
Bilirubin
67%
Transaminitis
67%
Mucositis
50%
Pulmonary
50%
Neurologic Pain
42%
Cardiac
33%
Creatinine
33%
Diarrhea
25%
Fever
25%
Acute Renal Failure
25%
Fatigue
17%
Acute Respiratory Failure
17%
Skin Rash
17%
BK Cystitis
8%
Cardiac Dysfunction
8%
Gastrointestional (GI) Bleed
8%
Seizure/Encephalopathy
8%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fludarabine + Melphalan
Gemcitabine + Fludarabine + Melphalan
TN28 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Antithymocyte globulin (ATG)Experimental Treatment1 Intervention
Antithymocyte globulin (ATG) will be intravenously administered over two days, with a total of 2 infusion periods. The first infusion is given at baseline visit (day 1), the second is given the next day at baseline visit (day 2). Body weight at baseline (Day 0- admission for the ATG/placebo infusion) will be used in calculating the doses for all infusions. The first dose (0.5mg/kg) will be infused over a minimum of 4 hours, and the second dose (2mg/kg) over a minimum of 4 hours with a maximum infusion time for each infusion of 10 hours. The second dose should be given no less than 12 and no more than 30 hours from the start of the first infusion. The final prepared product is to be labeled to protect the blind. Infusions may be administered either in a hospital or outpatient setting at the investigator's or institutions discretion.
Group II: PlaceboPlacebo Group1 Intervention
0.9% Sodium Chloride Injection USP ("Normal" saline) is to be dispensed as the placebo for this study. The placebo is to be prepared dispensing an infusion bag of 0.9% Sodium Chloride Injection USP ("Normal" saline) with no additives (no ATG, no premedications) and label the product to protect the blind. The placebo will also be administered over a minimum of 4 hours for the first and second doses with a maximum infusion time of 10 hours. The second dose of the placebo arm should be given no less than 12 and no more than 30 hours from the start of the first infusion. Infusions may be administered either in a hospital or outpatient setting at the investigator's or institutions discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antithymocyte Globulin
2000
Completed Phase 3
~180
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,358 Previous Clinical Trials
4,315,127 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hemoglobin levels are below the normal range for my age and gender.I have received or will receive the flu shot at least 2 weeks before joining the study.I am up to date on vaccinations and have no untreated health issues.You have had tuberculosis in the past or currently have tuberculosis.I am between 12 and 34 years old.I meet the criteria for early-stage diabetes and have high-risk markers.My autoimmune thyroid or celiac disease has been under control for the last 6 months.I have diabetes with two or more specific autoantibodies present.You have HIV, Hepatitis B, or Hepatitis C infection now or in the past.I have had cancer other than skin cancer in the past.I am using non-insulin diabetes medication.I meet the criteria for early-stage diabetes and have high-risk markers.It has been over 4 weeks since my last live vaccine.I am an adult fully vaccinated or a child on track with vaccinations per AAP guidelines.I agree not to get any vaccines, except for the flu shot, for 3 months after the study drug treatment.I am currently using immunosuppressive drugs or steroids regularly.My kidney function is not normal, as shown by my creatinine levels.My BMI is within the healthy range for my age.I have not received a live virus vaccine in the last 4 weeks.I am fully vaccinated against COVID-19, including boosters, and tested negative recently.My blood pressure is below 130/80 mmHg if I'm 18 or older, or below the 95th percentile for my age, sex, and height if I'm younger.Your bilirubin levels are higher than normal, unless you have been diagnosed with Gilbert's Disease.Your liver function tests show abnormal levels of AST or ALT.I do not have symptoms of an active infection, including COVID-19.I have a weak immune system or low blood cell counts.I have tested negative for CMV and EBV in the last 30 days and haven't had symptoms of these viruses for more than 7 days.I do not have heart, lung, blood, or neurological conditions that could affect the study.I have previously been treated with Teplizumab.I was diagnosed with Stage 3 Type 1 Diabetes.I am willing to give my consent, or my guardian will if I'm under 18.I was in a diabetes prevention trial and got the treatment less than 3 months ago.I have been treated with ATG or am allergic to rabbit products.You have had bad reactions to heparin before.I live or can stay close to the treatment center and a hospital for 3 days during my treatment.You are allergic to ATG.My weight is above the 5th percentile for my age and sex.
Research Study Groups:
This trial has the following groups:- Group 1: Antithymocyte globulin (ATG)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Antithymocyte globulin (ATG) as a viable medical treatment?
"Patient safety is a top priority for our team at Power, and after carefully assessing the clinical data available, we rated Antithymocyte globulin (ATG) with a score of 2. This was due to Phase 2 trial findings which suggested some safety but no efficacy."
Answered by AI
What maladies does Antithymocyte globulin (ATG) typically address?
"Antithymocyte globulin (ATG) can aid in the treatment of acute renal rejection, myelodysplastic syndrome, and immunosuppressive therapy."
Answered by AI
Does this research accommodate participants younger than 20 years old?
"As stated in the inclusion criteria, participants between 12 and 34 years old are eligible for this trial. For those younger than twelve or older than 65, there are 178 studies and 197 trials respectively that may be suitable."
Answered by AI
Are there any other studies that have investigated the effects of Antithymocyte globulin (ATG)?
"Currently, 54 medical studies are underway for the drug Antithymocyte globulin (ATG), with 7 trials in Phase 3. The vast majority of these clinical investigations are occurring at a research centre located in Gainesville, Florida; yet there is additional activity across 347 different sites nationwide."
Answered by AI
Are there vacant slots available to participate in this experiment?
"That is accurate. According to clinicaltrials.gov, this medical trial was initially listed on January 1st 2023 and recently revised on May 1st of the same year. The study requires 114 people over a single location in order to move forward."
Answered by AI
How many participants are currently enlisted in this trial?
"Affirmative, clinicaltrials.gov confirms that this medical research is currently enrolling participants. The trial was first published on January 1st 2023 and has been updated as recently as May 1st of the same year. To date, 114 individuals have been recruited from a single site to participate in the study."
Answered by AI
Am I eligible to take part in this investigative work?
"This trial seeks to enrol 114 individuals between 12 and 34 with type 1 diabetes. Candidates need to satisfy specific requirements, such as having 2 or more applicable autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A), a body mass index within the 5th percentile for their age group (if under 18) or <30 if an adult (<18 years old), HbA1c ≥5.7 yet <6.5%, DPTRS ≥ 7.4; dysglycemia must be present in some form, being 4 weeks away from receiving any live"
Answered by AI
Who else is applying?
What site did they apply to?
Indiana University - Riley Hospital for Children
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
Wanna help with studies for diabetes patients in 3futuree and. Now.
PatientReceived 2+ prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger