The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02000687
Recruitment Status : **RECRUITING NOW**
First Posted : December 4, 2013
Last Update Posted : February 28, 2023
Sponsor:
Information provided by (Responsible Party):
Rodolfo Alejandro, University of Miami
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Brief Summary:
This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.
Type 1 Diabetes Mellitus
Detailed Description:
After complete islet graft loss is determined, patient’s maintenance immunosuppression (i.e. sirolimus, tacrolimus, MMF and/or Myfortic®) will be discontinued and they will be monitored for 10 years thereafter, for the appearance of allosensitization using panel reactive antibody (PRA) levels and monitor the persistence of elevated PRA levels. Primary objective is to determine the rate of allosensitization in patients 3 years after failed islet transplantation (i.e. stimulated c-peptide <0.3mg/mL) and monitor the persistence of elevated PRA levels (≥ 20%) at year 3, 6, and 9. Timing, frequency and level of change in PRA will be monitored after all immunosuppression is discontinued.
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Study Type :
Observational
Estimated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss
Study Start Date :
December 2008
Estimated Primary Completion Date :
December 2026
Estimated Study Completion Date :
July 2027
Resource links provided by the National Library of Medicine
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Primary Outcome Measures :
determine the rate of allosensitization in patients after failed islet transplantation [ Time Frame: 10 years ]
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Information from the National Library of Medicine
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Ages Eligible for Study: Â
18 Years to 75 Years  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
No
Sampling Method: Â
Non-Probability Sample
Ages 18-75 years old that received at least one IT. Participants will be obtained from the pool of islet transplant recipients transplanted at the Diabetes Research Institute at the University of Miami, Miller School of Medicine.
Inclusion Criteria:
1. History of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant).
Exclusion Criteria:
Inability to provide written informed consent.
Mentally unstable and/or unable to comply with the procedures of the study protocol.
History of any solid organ transplant.
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000687
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Diabetes Research Institute
Miami, Florida, United States, 33136
Contact: Rodolfo Alejandro, MD   305-243-5321   islet@med.miami.edu  Â
Contact: Ana M Alvarez, APRN   305 243-3389   axa383@med.miami.edu  Â
Principal Investigator: Rodolfo Alejandro, MD Â Â Â Â Â Â
Sub-Investigator: David A Baidal, MD Â Â Â Â Â Â
Rodolfo Alejandro
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Principal Investigator:
Rodolfo Alejandro, MD
University of Miami
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Rios P, Baidal D, Lemos J, Camhi SS, Infante M, Padilla N, Alvarez Gil AM, Fuenmayor V, Ambut J, Qasmi FA, Mantero AM, Cayetano SM, Ruiz P, Ricordi C, Alejandro R. Long-term Persistence of Allosensitization After Islet Allograft Failure. Transplantation. 2021 Nov 1;105(11):2490-2498. doi: 10.1097/TP.0000000000003635.
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Responsible Party:
Rodolfo Alejandro, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier:
NCT02000687 Â Â
Other Study ID Numbers:
20080127
First Posted:
December 4, 2013 Â Â Key Record Dates
Last Update Posted:
February 28, 2023
Last Verified:
February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1Diabetes MellitusGlucose Metabolism DisordersMetabolic Diseases
Endocrine System DiseasesAutoimmune DiseasesImmune System Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
