NCT00315588

Brief Summary

The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 1, 2000

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3 years until next milestone

Results Posted

Study results publicly available

April 12, 2017

Completed
Last Updated

April 12, 2017

Status Verified

November 1, 2016

Enrollment Period

13.4 years

First QC Date

April 14, 2006

Results QC Date

December 19, 2016

Last Update Submit

February 28, 2017

Conditions

Diabetes Mellitus, Type 1

Keywords

Islet Transplantation

Outcome Measures

Primary Outcomes (1)

  • Insulin Independence.

    Number of Participants who Achieved Insulin Independence at 1 Year

    1 year

Secondary Outcomes (3)

  • Stimulated C-peptide Greater Than 0.5 ng/ml

    1 year

  • Reduction of Insulin Requirements

    1year

  • Reduction in Severe Hypoglycemia, Improvement in Hypoglycemia Awareness

    1 years

Study Arms (1)

Islet Transplantation

EXPERIMENTAL

Islet Transplantation in subjects with a previous kidney transplant.

Drug: Islet Transplantation

Interventions

Islet TransplantationDRUG

Islet Transplantation in subjects with a previous kidney transplant.

Also known as: islet
Islet Transplantation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between 18 and 60 years of age.
  • Patients with type 1 diabetes mellitus.
  • Patients with a renal transplant that is more than 6 months old.
  • Patients with stable renal graft function for the preceding 6 months, i.e. no episodes of rejection and changes in serum creatinine no more than 0.5 mg/dl from baseline.
  • Patients who are taking tacrolimus, sirolimus +/- steroids for maintenance immunosuppression for at least 6 months and are tolerating levels satisfactory for islet transplantation without severe complications.
  • Patients with a body mass index (BMI) of less than or equal to 26.

You may not qualify if:

  • Stimulated or basal C-peptide \> 0.3 ng/ml.
  • Patients with unstable renal function - serum creatinine greater than 0.5 mg/dl above baseline.
  • Patients with corrected creatinine clearance of less than 40.
  • Patients weighing more than 80 kg.
  • Patients with a body mass index (BMI) of greater than 26.
  • Insulin requirement \> 1.0 U/kg/d.
  • Anemia (hemoglobin: males \< 11.0 g/dl; females \< 10.0 g/dl).
  • Abnormal liver function tests (consistently \> 1.5 x normal range).
  • Unstable diabetic retinopathy.
  • Evidence of acute or chronic active Epstein-Barr virus (EBV) infection (IgM ≥ IgG). Patients will be eligible if serological testing becomes consistent with previous exposure (i.e. IgG \> IgM).
  • Patients with history of malignancy or current malignancy other than non-melanomatous skin cancer, or finding of any lesions or symptoms during screening that are suspicious for malignancy, until properly investigated and ruled out.
  • Patients with elevation of prostate-specific antigen \> 4 unless malignancy has been excluded.
  • Patients with unstable cardiovascular status.
  • Patients with active infections until adequately treated, unless treatment is not judged as necessary by the investigators (including, but not limited to, mild skin and nail fungal infections).
  • Patients with serological evidence of infection with HIV, human t cell lymphotropic virus 1 (HTLV 1), HTLV 2, or hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable).
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Institute

Miami, Florida, 33136, United States

Location

Related Publications (3)

  • Cure P, Pileggi A, Froud T, Messinger S, Faradji RN, Baidal DA, Cardani R, Curry A, Poggioli R, Pugliese A, Betancourt A, Esquenazi V, Ciancio G, Selvaggi G, Burke GW 3rd, Ricordi C, Alejandro R. Improved metabolic control and quality of life in seven patients with type 1 diabetes following islet after kidney transplantation. Transplantation. 2008 Mar 27;85(6):801-12. doi: 10.1097/TP.0b013e318166a27b.

    PMID: 18360260RESULT

  • Faradji RN, Froud T, Messinger S, Monroy K, Pileggi A, Mineo D, Tharavanij T, Mendez AJ, Ricordi C, Alejandro R. Long-term metabolic and hormonal effects of exenatide on islet transplant recipients with allograft dysfunction. Cell Transplant. 2009;18(10):1247-59. doi: 10.3727/096368909X474456.

    PMID: 20003758DERIVED

  • Tharavanij T, Betancourt A, Messinger S, Cure P, Leitao CB, Baidal DA, Froud T, Ricordi C, Alejandro R. Improved long-term health-related quality of life after islet transplantation. Transplantation. 2008 Nov 15;86(9):1161-7. doi: 10.1097/TP.0b013e31818a7f45.

    PMID: 19005394DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Islets of Langerhans Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsEndocrine Surgical ProceduresSurgical Procedures, OperativeTransplantation

Results Point of Contact

Title
Dr. Rodolfo Alejandro
Organization
University of Miami Miller School of Medicine Miami Fl
ralejand@med.miami.edu
305 243 5324

Study Officials

  • Rodolfo Alejandro, M.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 18, 2006

Study Start

December 1, 2000

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

April 12, 2017

Results First Posted

April 12, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)