Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients

NCT00888628 | Completed Phase 1 Results DMC

• 1 other identifier: IAK
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type I

Keywords

Type I diabetes; Islet after Kidney Transplant; Islet transplantation

Outcome Measures

Primary Outcomes (1)

• Insulin Independence With Both an HbA1c ≤ 6.5% and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant or a Reduction in HbA1c of at Least 1 Point and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant.

  1 year after the subject's first islet transplant

Secondary Outcomes (8)

• Number of Participants With a Decrease in HbA1c

  1 year after subject's first islet transplant

• Stable or Decrease in Urinary Albumin and Creatinine Ratio and Serum Creatinine

  1 year after subjects initial islet transplant

• An Absence Cardiovascular Events, Cerebral Vascular Accident, and Myocardial Infarction

  1 year after the subject's first islet transplant

• Impact on Vision

  1 year after the subject's first islet transplant

• Absence of Negative Renal Impact Measures

  1 year after the subject's first islet transplant

Study Arms (1)

Islet transplant

EXPERIMENTAL

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.

Biological: Purified Pancreatic Islets; Drug: Etanercept

Interventions

Purified Pancreatic Islets BIOLOGICAL

Islet after kidney transplant in patients with type I diabetes.

Islet transplant

Etanercept DRUG

Given as induction for islet cell transplant

Islet transplant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Boston Area Diabetes Endocrinology Research Center (funded by NIDDK): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: James F. Markmann, M.D. Ph.D - Chief, Division of Transplant Surgery
• Organization: Massachusetts General Hospital

kcrisalli@mgh.harvard.edu

617-643-4087

Study Officials

• James F Markmann, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Division of Transplantation

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 27, 2009
• Study Start: May 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2016
• Last Updated: November 29, 2017
• Results First Posted: January 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)