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Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Boston Area Diabetes Endocrinology Research Center (funded by NIDDK)
Information provided by (Responsible Party):
James F. Markmann, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00888628
First received: April 23, 2009
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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

Condition Intervention Phase
Diabetes Mellitus, Type I
 Biological: Purified Pancreatic Islets
Drug: Etanercept
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Islet Transplantation in Type 1 Diabetic Kidney Allograft Recipients

Resource links provided by NLM:

Drug Information available for: Etanercept
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • The safety of islets isolated at Massachusetts General Hospital (MGH) and the proportion of insulin independent subjects [ Time Frame: 1 year after the subject's first islet transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HbA1c and number of hypoglycemic events [ Time Frame: 1 year after subject's first islet transplant ] [ Designated as safety issue: Yes ]
  • Urinary albumin and creatinine ratio and serum creatinine [ Time Frame: 1 year after subjects initial islet transplant ] [ Designated as safety issue: Yes ]
  • Cardiovascular events, CVA, and MI [ Time Frame: 1 year after the subject's first islet transplant ] [ Designated as safety issue: Yes ]
  • Impact on vision [ Time Frame: 1 year after the subject's first islet tranplant ] [ Designated as safety issue: No ]
  • Renal impact measures including renal allograft survival [ Time Frame: 1 year after the subject's first islet transplant ] [ Designated as safety issue: Yes ]
  • Measures of metabolic control [ Time Frame: 1 year after the subject's first islet transplant ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8
Study Start Date: May 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

 Biological: Purified Pancreatic Islets
Islet after kidney transplant in patients with type I diabetes.
Drug: Etanercept
Given as induction for islet cell transplant

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 BK virus
  • Untreated hyperlipidemia
  • Recent hemorrhagic stroke
  • Factors associated with an increased risk of bleeding

Contact PI for complete Incl-Excl criteria list.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888628

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Boston Area Diabetes Endocrinology Research Center (funded by NIDDK)
Investigators
Principal Investigator: James F Markmann, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: James F. Markmann, MD, PhD, Chief Division of Transplantation, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00888628     History of Changes
Other Study ID Numbers: IAK-1642
Study First Received: April 23, 2009
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Type I diabetes
Islet after Kidney Transplant
Islet transplantation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013