Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Rodolfo Alejandro, University of Miami
ClinicalTrials.gov Identifier:
NCT02000687
First received: November 26, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.


Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • determine the rate of allosensitization in patients after failed islet transplantation [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2008
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Rodolfo Alejandro, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT02000687     History of Changes
Other Study ID Numbers: 20080127
Study First Received: November 26, 2013
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 10, 2014