Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients

NCT ID: NCT00888628

Last Updated: 2017-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2016-08-31

Brief Summary

The purpose of the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant.

The primary objectives of the study are:

• To set up islet transplantation in patients who have had a kidney transplant and who are using an immunosuppressive regimen that works

The Secondary objective of the study is:

• To find out if successful islet transplantation leads to improved metabolic control and reduced renal complication from diabetes

Detailed Description

Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence. For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft. Induction therapy for subsequent transplants will be 2doses of basiliximab.

All patients will receive Etanercept to promote engraftment.

Conditions

Diabetes Mellitus, Type I

Keywords

Type I diabetes; Islet after Kidney Transplant; Islet transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Islet transplant

Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.

For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.

Induction therapy for subsequent transplants will be 2 doses of basiliximab.

All patients will receive Etanercept to promote engraftment.

Group Type: EXPERIMENTAL

Purified Pancreatic Islets

Intervention Type: BIOLOGICAL

Islet after kidney transplant in patients with type I diabetes.

Etanercept

Intervention Type: DRUG

Given as induction for islet cell transplant

Interventions

Purified Pancreatic Islets

Islet after kidney transplant in patients with type I diabetes.

Intervention Type: BIOLOGICAL

Etanercept

Given as induction for islet cell transplant

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female subjects
• Age 18 to 70 years of age
• Have insulin dependent Diabetes Mellitus Type 1
• Are post-renal transplant on maintenance immunosuppression with stable renal function
• HbA1c > 7.5% or < 7.5% and hypoglycemia unawareness

Exclusion Criteria

• Weight more than 90 kg
• Insulin requirement > 60 Units/day
• Other (non-kidney) organ transplants except prior failed pancreatic graft.
• Untreated or unstable proliferative diabetic retinopathy
• Presence of de novo antibody production since the renal allograft or either Class I or Class II panel-reactive anti-HLA antibodies
• Active infection
• Negative screen for Epstein-Barr virus (EBV)
• Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
• History of Factor V Leiden mutation
• Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g. warfarin) after transplantation (low-dose aspirin treatment is allowed) or subjects with international normalized ratio (INR) > 1.5
• Severe co-existing cardiac disease
• Persistent elevation of liver function tests at the time of study entry
• Acute or chronic pancreatitis
• Male subjects with elevation of prostate specific antigen
• Pregnancy
• Positive screen for polyoma (BK) virus
• Untreated hyperlipidemia
• Recent hemorrhagic stroke
• Factors associated with an increased risk of bleeding

Contact PI for complete Incl-Excl criteria list.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Area Diabetes Endocrinology Research Center (funded by NIDDK)

UNKNOWN

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

James F. Markmann, MD, PhD

Chief Division of Transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James F Markmann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IAK

Identifier Type: -

Identifier Source: org_study_id