NCT02000687

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
26mo left

Started Dec 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Dec 2008Jul 2028

Study Start

First participant enrolled

December 1, 2008

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

19 years

First QC Date

November 26, 2013

Last Update Submit

March 18, 2026

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • determine the rate of allosensitization in patients after failed islet transplantation

    10 years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Institute

Miami, Florida, 33136, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33481552DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Rodolfo Alejandro, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 4, 2013

Study Start

December 1, 2008

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

US(1)