Trial Outcomes & Findings for Steroid-free and Long-term Calcineurin-free Trial in Islet Cell Transplantation (NCT NCT00315627)
NCT ID: NCT00315627
Last Updated: 2017-05-25
Results Overview
Number of subjects at 1 year with HbA1c \< 6.5% and absence of severe hypoglycemia
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
1 year
Results posted on
2017-05-25
Participant Flow
Participant milestones
| Measure |
Islet Transplantation
Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Steroid-free and Long-term Calcineurin-free Trial in Islet Cell Transplantation
Baseline characteristics by cohort
| Measure |
Islet Transplantation
n=3 Participants
Islet transplantation: Islet transplantation
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearNumber of subjects at 1 year with HbA1c \< 6.5% and absence of severe hypoglycemia
Outcome measures
| Measure |
Islet Transplantation
n=3 Participants
Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
|
|---|---|
|
Measurement of Glycemic Control by HbA1c and Prevention of Severe Hypoglycemia
|
3 participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of subjects with basal C-peptide greater than 0.5 ng/ml
Outcome measures
| Measure |
Islet Transplantation
n=3 Participants
Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
|
|---|---|
|
Islet Allograft Function
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of subjects with a hemoglobin A1c \< 6.5% at 1year after islet transplantation
Outcome measures
| Measure |
Islet Transplantation
n=3 Participants
Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
|
|---|---|
|
Improvement in Metabolic Control as Evidenced by Hemoglobin A1c < 6.5%
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe number of subjects with severe hypoglycemia after transplantation
Outcome measures
| Measure |
Islet Transplantation
n=3 Participants
Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
|
|---|---|
|
Elimination of Severe Hypoglycemia
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe number of subjects with restoration of hypoglycemia awareness 1 year after islet transplantation
Outcome measures
| Measure |
Islet Transplantation
n=3 Participants
Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
|
|---|---|
|
Restoration of Hypoglycemia Awareness 1 Year After Transplantation
|
3 Participants
|
Adverse Events
Islet Transplantation
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Islet Transplantation
n=3 participants at risk
Islet transplantation alone under alentuzumab (Campath1H) induction.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
3/3 • Number of events 3 • 3 years
|
|
Immune system disorders
Hypersensitivity
|
33.3%
1/3 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Islet Transplantation
n=3 participants at risk
Islet transplantation alone under alentuzumab (Campath1H) induction.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Hair loss
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Displastic Nevus
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Acne/Folliculitis
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Microalbuminuria
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Overt Proteinuria
|
100.0%
3/3 • Number of events 3 • 3 years
|
|
Renal and urinary disorders
Urinary tract infection
|
66.7%
2/3 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Gallblader polyp
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Pulpitis
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Gastroenteritis
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rinorrhea
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Flu like symptoms
|
33.3%
1/3 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Right foot injury
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
66.7%
2/3 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Toe sprain
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Yeast infection
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Uterine fibroids
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Hot Flashes
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Abnormal Papsmear
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Nervous system disorders
Tremors
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Nervous system disorders
Headaches
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Nervous system disorders
Memory deficit
|
100.0%
3/3 • Number of events 4 • 3 years
|
|
Nervous system disorders
Paresthesia
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Nervous system disorders
Other
|
100.0%
3/3 • Number of events 3 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Cardiac disorders
Edema
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Vascular disorders
Thrombophlebitis Right arm
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Eye disorders
Capsular opacity
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Eye disorders
Cataract
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • Number of events 3 • 3 years
|
Additional Information
Dr. Rodolfo Alejandro
University of Miami Miller School of Medicine
Phone: 305 243-5324
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place