Islet After Kidney Transplant for Type 1 Diabetes

Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00784966

Enrollment

Registered

2008-11-05

Start date

2011-08-31

Completion date

2017-09-30

Last updated

2014-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Islet transplantation, Type 1 Diabetes Mellitus, Kidney Transplantation

Brief summary

The purpose of this study is to determine if prolonged administration of the anti TNF (tumor necrosis factor)-Alpha agent etanercept is associated with enhanced graft survival in patients undergoing islet after kidney transplantation.

Interventions

DRUGetanercept

Treatment option 'A'-Two weeks treatment with etanercept. The first dose of 50mg in normal saline will be given intravenously one hour before transplant. Then 25mg will be administered subcutaneously two times a week for two weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Patients with type 1 diabetes mellitus, who have a stable functioning renal transplant, are taking the appropriate maintenance immunosuppression and have no severe health problems that preclude them receiving an islet transplant will be considered for inclusion.

Exclusion criteria

* Have a history of or findings suggestive of unstable diabetic complications (e.g. active eye disease) * Active infections (clinically or by laboratory testing) * History of current malignancy or suspicion of malignancy until properly investigated and excluded * Liver or biliary abnormalities * Unstable cardiovascular disease * Findings to suggest immunological sensitization or those women who have the potential to get pregnant and are not using a sufficient method of contraception

Design outcomes

Primary

Measure	Time frame
The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy.	Outcome measures will be assessed at protocol prescribed intervals. Long term outcomes assessment will be measured at 5 years post transplant or all evidence of islet function has ceased plus six months.

Secondary

Measure	Time frame
Reduction in insulin requirements in those patients who do not achieve insulin independence with improved metabolic control.	Outcome measures will be assessed at protocol prescribed intervals.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026