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Trial record 3 of 43 for:    Open Studies | "Hypoglycemic Agents"

A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Xunrong Luo, Northwestern University
ClinicalTrials.gov Identifier:
NCT01897688
First received: July 9, 2013
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.


Condition Intervention Phase
Type 1 Diabetes
Severe Hypoglycemic Unawareness
Biological: Islet Cell Transplant
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • To demonstrate the safety and efficacy of islet transplantation under alemtuzumab induction for treatment of Type-1 Diabetes (T1D) in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes. [ Time Frame: 365 days after final islet infusion ] [ Designated as safety issue: Yes ]
    To assess the efficacy of islet cell transplantation under alemtuzumab induction immunosuppression on the proportion of subjects with a change in HbA1c and free of severe hypoglycemic events through Day 365 after the final islet transplant.


Secondary Outcome Measures:
  • To relate clinical transplant outcomes based upon islet quantity/quality to organ donor characteristics. [ Time Frame: 365 days after final islet infusion ] [ Designated as safety issue: No ]
    To assess the proportion of insulin-independent subjects at Day 365 after the final islet transplant. TO compare islet graft outcome between alemtuzumab induction and historical antithymocyte induction groups. To relate clinical transplant outcomes based upon islet quantity/quantity to organ donor characteristics.


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Islet Cell Transplant
All qualified subjects will be put on United Network for Organ Sharing (UNOS) Islet Transplant wait list for potential islet cell transplant.
Biological: Islet Cell Transplant

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients age 18-65 years of age
  2. Ability to provide written informed consent
  3. Mentally stable and able to comply with the procedures of the study protocol
  4. Patients with T1D and insulin-dependent for at least 5 years
  5. Absent stimulated c-peptide (<0.3 ng/mL) in response to a mixed meal tolerance test (MMTT; ensure 6 mL/kg body weight to a maximum of 360mL) measured at 60 and 90 min after the start of consumption
  6. Patients who have been followed by a qualified physician for diabetes management for a minimum of 12 months
  7. At least one episode of severe hypoglycemia in the past 12 months
  8. A Clarke score of 4 or more defining reduced awareness of hypoglycemia

Exclusion Criteria:

  1. Body mass index (BMI) > 30
  2. Insulin requirement of > 1.0 IU/kg/day
  3. HbA1c > 10%
  4. Calculated glomerular filtration rate (GFR) < 80 milliliter/minute (using subjects serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI)
  5. Macroalbuminuria >300 mg/g creatinine
  6. Panel reactive anti-Human Leukocyte Antigen antibodies> 50% by flow cytometry
  7. For female subjects: positive pregnancy test, breast feeding or unwillingness to use effective contraceptive measures for the duration of the study.
  8. Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB)
  9. Negative Epstein-Barr Virus (EBV) by (IgG) Immunoglobulin G
  10. Any history of malignancy except resected squamous or basal cell carcinoma
  11. Alcohol or substance abuse
  12. Baseline Hb below the lower limit of normal
  13. International normalized ratio >1.5 and long term anticoagulant therapy
  14. Clinically significant coronary artery disease
  15. Elevated liver function tests >1.5 times upper limit of normal
  16. Symptomatic cholecystolithiasis
  17. Gastrointestinal disorders interfering with ability to absorb oral medications
  18. Uncontrolled hyperlipidemia (LDL cholesterol >130 mg/dL and/or triglycerides >200 mg/dL)
  19. Chronic corticosteroid use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897688

Contacts
Contact: Xunrong Luo, MD, PhD (312) 908-8147 xunrongluo@northwestern.edu
Contact: Natalie Monson, BA (312) 694-0253 natalie.monson@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Xunrong Luo, MD, PhD    312-908-8147    xunrongluo@northwestern.edu   
Contact: Natalie Monson, BA    (312) 694-0253    natalie.monson@northwestern.edu   
Principal Investigator: Xunrong Luo, MD, PhD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Xunrong Luo, MD, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Xunrong Luo, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01897688     History of Changes
Other Study ID Numbers: STU00059469
Study First Received: July 9, 2013
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
Diabetes
Islet
Pancreas
Hypoglycemia
T1D
Transplant

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014