Phase 2
N=7
Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients
Diabetes Mellitus, Type I
Bottom Line
View on ClinicalTrials.gov: NCT00888628 ↗Enrolled (actual)
7
Serious AEs
75.0%
Results posted
Jan 2017
Primary outcome: Primary: 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. — 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Purified Pancreatic Islets (Biological); Etanercept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
4 | — |
| SECONDARY Number of Participants With a Decrease in HbA1c |
4 | — |
| SECONDARY Stable or Decrease in Urinary Albumin and Creatinine Ratio and Serum Creatinine |
4 | — |
| SECONDARY An Absence Cardiovascular Events, Cerebral Vascular Accident, and Myocardial Infarction |
4 | — |
| SECONDARY Impact on Vision |
2 | — |
| SECONDARY Absence of Negative Renal Impact Measures |
4 | — |
| SECONDARY Improvement of Metabolic Control |
4 | — |
| SECONDARY Number of Participants With a Decrease of Severe Hypoglycemic Events |
4 | — |
| SECONDARY Reduction of Insulin Requriements |
4 | — |
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
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 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.
Data sourced from ClinicalTrials.gov (NCT00888628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.