Actively Recruiting
Islet Transplantation in Type 1 Diabetic Kidney Allograft
Led by University of Chicago · Updated on 2025-12-08
10
Participants Needed
1
Research Sites
834 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to learn about the safety of islet transplantation when performed after kidney transplantation, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin. These cells will be obtained from cadaver (non-living) donors and given to subjects by vein.
CONDITIONS
Official Title
Islet Transplantation in Type 1 Diabetic Kidney Allograft
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18 to 68 years
- Able to provide written informed consent and comply with study procedures
- Clinical history compatible with Type 1 Diabetes with disease onset before 40 years
- Insulin-dependent for more than 5 years at enrollment
- Sum of subject age and insulin-dependent diabetes duration greater than 28
- Absent stimulated c-peptide (< 0.3 ng/mL) in response to a mixed meal tolerance test
- At least 3 months post-renal transplant on appropriate calcineurin inhibitor-based immunosuppression or scheduled to receive islet transplantation within 72 hours after kidney transplant from the same donor
- Stable renal function defined by creatinine no more than one third higher than average in the prior 3 months until rejection, obstruction, or infection is ruled out
You will not qualify if you...
- Weight over 90 kg or body mass index (BMI) greater than 30 kg/m2
- Insulin requirement greater than 1.0 IU/kg/day or less than 15 units per day
- Prior organ transplants other than kidney, except prior failed pancreatic graft with specific conditions
- Untreated or unstable proliferative diabetic retinopathy
- Blood pressure: systolic over 160 mmHg or diastolic over 100 mmHg despite treatment
- Calculated glomerular filtration rate (GFR) below 40 mL/min/1.73 m2, excluding strict vegetarians with GFR below 35 mL/min/1.73 m2
- New onset proteinuria (albumin/creatinine ratio over 300 mg/g) since kidney transplantation
- Panel-reactive anti-HLA antibodies over 50% with positive cross-match or donor-specific antibodies
- For females: positive pregnancy test, breastfeeding, desire to become pregnant during or after study, or unwillingness to use effective contraception during study and 4 months after
- For males: intent to father a child during study and 4 months after, or unwillingness to use effective contraception
- Presence or history of active infections including hepatitis B, hepatitis C, HIV, or tuberculosis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
L
Lindsay Basto, RN, BSN
CONTACT
P
Piotr Witkowski, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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