Phase 2
N=5
MGA031, Sirolimus and Tacrolimus in Islet Transplantation
Type 1 Diabetes Mellitus · Hypoglycemia
Bottom Line
View on ClinicalTrials.gov: NCT00265473 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: Subjects With Full Islet Function. — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Allogeneic Islets of Langerhans (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects With Full Islet Function. |
3 | — |
| PRIMARY Serious Adverse Events Related to Immunosuppressive Therapy. |
— | — |
| SECONDARY Subjects With Partial Islet Function and no Episodes of Severe Hypoglycemia; |
— | — |
| SECONDARY Insulin Independent Single-donor Subjects. |
1 | — |
| SECONDARY Insulin Independent Multiple-donor Subjects. |
1 | — |
Summary
This clinical trial is designed to extend the observations made in our pilot clinical trial (IND 8971, Study #1) on the safety and efficacy of immunotherapy with the anti-CD3 monoclonal antibody hOKT3γ1 (Ala-Ala), (currently called MGA031) combined with sirolimus and tacrolimus in preventing rejection and autoimmune destruction of deceased donor pancreatic islet transplants in type 1 diabetic recipients.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 65 years of age.
- Ability to provide written informed consent.
- Mentally stable and able to comply with the procedures of the study.
- Clinical history compatible with type 1 diabetes with onset of disease at 5 years at the time of enrollment.
- Absent stimulated C-peptide ( 27 kg/m2 or patient weight ≤ 50kg.
- Insulin requirement of > 0.8 IU/kg/day or 50 IU/day.
- HbA1c >10%.
- Untreated proliferative diabetic retinopathy.
- Uncontrolled Hypertension.
- Estimated glomerular filtration rate 300mg/d).
- Presence or history of panel-reactive anti-HLA antibodies >20% by flow cytometry.
- Females: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3 months after discontinuation. Males: intent to procreate during the duration of the study or within 3 months after discontinuation or unwillingness to use effective measures of contraception.
- Active infection.
- Negative screen for Epstein-Barr Virus (EBV).
- Invasive aspergillus infection within one year prior to study entry.
- Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
- Active alcohol, tobacco or substance abuse.
- Baseline Hgb below the lower limits of normal at the local laboratory; lymphopenia, neutropenia, or thrombocytopenia.
- A history of Factor V deficiency.
- Any coagulopathy or medical condition requiring long-term anticoagulant therapy.
- Severe co-existing cardiac disease.
- Persistent elevation of liver function tests.
- Symptomatic cholecystolithiasis.
- Acute or chronic pancreatitis.
- Symptomatic peptic ulcer disease.
- Unremitting diarrhea, vomiting or other gastrointestinal disorders potentially interfering with absorption.
- Hyperlipidemia despite medical therapy (fasting LDL cholesterol > 130 mg/dl, treated or untreated; and/or fasting triglycerides > 200 mg/dl).
- Chronic use of systemic steroids.
- Use of any other investigational agents within 4 weeks of participation.
- Administration of live attenuated vaccine(s) within 2 months of enrollment.
- Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Data sourced from ClinicalTrials.gov (NCT00265473). 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.