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Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

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ClinicalTrials.gov Identifier: NCT02000687
Recruitment Status : Recruiting
First Posted : December 4, 2013
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.

Condition or disease
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.

Study Design

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 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. determine the rate of allosensitization in patients after failed islet transplantation [ Time Frame: 10 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

1. History of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant).

Exclusion Criteria:

  1. Inability to provide written informed consent.
  2. Mentally unstable and/or unable to comply with the procedures of the study protocol.
  3. History of any solid organ transplant.
Contacts and Locations

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


Locations
United States, Florida
Diabetes Research Institute Recruiting
Miami, Florida, United States, 33136
Contact: Rodolfo Alejandro, MD    305-243-5321    islet@med.miami.edu   
Principal Investigator: Rodolfo Alejandro, MD         
Sponsors and Collaborators
Rodolfo Alejandro
Investigators
Principal Investigator: Rodolfo Alejandro, MD University of Miami
More Information

Additional Information:
Responsible Party: Rodolfo Alejandro, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT02000687     History of Changes
Other Study ID Numbers: 20080127
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases