NCT01999361 Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
| NCT ID | NCT01999361 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rodolfo Alejandro |
| Condition | Type 1 Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2009-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2009-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-center, prospective, open label study in islet transplant recipients after complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.
Eligibility Criteria
Inclusion Criteria: 1. Male and female patients age 18-70 years of age. 2. Ability to provide written informed consent. 3. Mentally stable and able to comply with the procedures of the study protocol. 4. Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation. 5. History of at least one islet transplant. 6. Stimulated C-peptide \<0.3 ng/ml. Exclusion Criteria: 1. Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension 2. For female participants: Positive pregnancy test or presently breast-feeding. 3. History of active infection including hepatitis B, hepatitis C, HIV, or TB. 4. Any history of malignancy except for completely resected squamous or basal skin cell carcinoma. 5. Known active alcohol or substance abuse. 6. Severe co-existing history of cardiac disease, characterized by a history of any one of these conditions: recent myocardial infarction (within past 6 months), evidence of ischemia on functional cardiac exam within the last year, or left ventricular ejection fraction \<30%. 7. History of persistent elevation of liver function tests. SGOT (AST), SGPT (ALT), alkaline phosphatase or total bilirubin, with values \>1.5 times normal upper limits will exclude a patient. 8. Evidence of inter-current infection. 9. Active peptic ulcer disease 10. History on non-adherence to prescribed regimens including immunosuppression. 11. PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.
Contact & Investigator
Rodolfo Alejandro, MD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT01999361 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Type 1 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01999361 currently recruiting?
Yes, NCT01999361 is actively recruiting participants. Visit ClinicalTrials.gov or contact Rodolfo Alejandro to inquire about joining.
Where is the NCT01999361 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT01999361 clinical trial?
NCT01999361 is sponsored by Rodolfo Alejandro. The principal investigator is Rodolfo Alejandro, MD at University of Miami. The trial plans to enroll 18 participants.
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