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NCT02464878 · ClinicalTrials.gov registry record · Phase 2
Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT02464878: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT02464878 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02464878, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Patients meeting the study entry criteria will receive 1-3 infusion(s) of in vitro cultured islets. Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks.
Primary Outcome
Insulin Independence examined 75 days after 1st infusion; subject considered to be insulin independent if they are able to titrate off insulin therapy for \<1 week AND all of the following are met: 1. one HbA1c level, one fasting serum glucose level, and a Mixed Meal Tolerance Test (MMTT) documented within the visit window at Day 75 (Day 70-80) and 7 days of blood sugar and insulin readings are documented within +/- 7 days of the visit window (Day 63-87); 2. HbA1c \</= 6.5% or a \>/= 2.5% decre
Interventions
- DRUG Thymoglobulin
- DRUG Etanercept
- DRUG Basiliximab
- DRUG Alpha 1-Antitrypsin
- PROCEDURE Islet Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2017-01 |
| Est. Completion | 2022-12 |
| Phase | Phase 2 |
What the finished NCT02464878 record still lists
NCT02464878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Thymoglobulin is the first listed.
NCT02464878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02464878 about?
NCT02464878 is a clinical study titled "Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant". Patients meeting the study entry criteria will receive 1-3 infusion(s) of in vitro cultured islets. Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks.
What is the current status of trial NCT02464878?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2017-01. Estimated completion is 2022-12.
What interventions are being tested in trial NCT02464878?
The interventions under investigation include: Thymoglobulin (DRUG), Etanercept (DRUG), Basiliximab (DRUG), Alpha 1-Antitrypsin (DRUG), Islet Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT02464878?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02464878's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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