Trial Outcomes & Findings for Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation (NCT NCT00315588)
NCT ID: NCT00315588
Last Updated: 2017-04-12
Results Overview
Number of Participants who Achieved Insulin Independence at 1 Year
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
1 year
Results posted on
2017-04-12
Participant Flow
Participant milestones
| Measure |
Islet Transplantation
Islet transplantation in subjects with previous kidney transplant.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
Baseline characteristics by cohort
| Measure |
Islet Transplantation
n=7 Participants
Islet transplantation in subjects with previous kidney transplant
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 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
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 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
|
7 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
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearNumber of Participants who Achieved Insulin Independence at 1 Year
Outcome measures
| Measure |
Islet Transplantation
n=7 Participants
Islet transplantation in subjects with previous kidney transplant.
|
|---|---|
|
Insulin Independence.
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearPartial graft function, as evidenced by basal C-peptide greater than 0.5 ng/ml
Outcome measures
| Measure |
Islet Transplantation
n=7 Participants
Islet transplantation in subjects with previous kidney transplant.
|
|---|---|
|
Stimulated C-peptide Greater Than 0.5 ng/ml
|
6 Participants
|
SECONDARY outcome
Timeframe: 1yearReduction in insulin requirements in those patients who do not achieve insulin independence
Outcome measures
| Measure |
Islet Transplantation
n=5 Participants
Islet transplantation in subjects with previous kidney transplant.
|
|---|---|
|
Reduction of Insulin Requirements
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 yearsElimination or reduction in the incidence of hypoglycemic coma or unawareness
Outcome measures
| Measure |
Islet Transplantation
n=7 Participants
Islet transplantation in subjects with previous kidney transplant.
|
|---|---|
|
Reduction in Severe Hypoglycemia, Improvement in Hypoglycemia Awareness
|
6 Participants
|
Adverse Events
Islet Transplantation
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Islet Transplantation
n=7 participants at risk
Islet transplantation in subjects with previous kidney transplant
|
|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Number of events 3
|
|
Cardiac disorders
Chest Pain
|
14.3%
1/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
3/7 • Number of events 3
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Increased Serum Creatinine
|
14.3%
1/7 • Number of events 1
|
|
Vascular disorders
Limb edema
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Squamous Cell Carcinoma in situ
|
28.6%
2/7 • Number of events 2
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
28.6%
2/7 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
28.6%
2/7 • Number of events 2
|
|
Social circumstances
Head Injury
|
14.3%
1/7 • Number of events 1
|
Other adverse events
| Measure |
Islet Transplantation
n=7 participants at risk
Islet transplantation in subjects with previous kidney transplant
|
|---|---|
|
Nervous system disorders
Tremors
|
14.3%
1/7 • Number of events 5
|
|
Nervous system disorders
Insomnia
|
28.6%
2/7 • Number of events 5
|
|
Nervous system disorders
Depression
|
14.3%
1/7 • Number of events 2
|
|
Nervous system disorders
Memory loss
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Headaches
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
42.9%
3/7 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukopenia
|
85.7%
6/7 • Number of events 6
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
3/7 • Number of events 5
|
|
Blood and lymphatic system disorders
Lymphopenia
|
28.6%
2/7 • Number of events 2
|
|
Gastrointestinal disorders
Buccal ulcers
|
42.9%
3/7 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Acne/Folliculitis
|
14.3%
1/7 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash (legs)
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Necrobiosis lipodica
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Onychomyosis
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Squamous cell carcinoma
|
14.3%
1/7 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
1st and 2nd degree burn
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin desquamation right index finger
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia Areata
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Onychocriptosis
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin, cracks on fingers
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Facial Erythema
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Increase creatinine
|
28.6%
2/7 • Number of events 2
|
|
Renal and urinary disorders
Microalbuminuria
|
42.9%
3/7 • Number of events 3
|
|
Renal and urinary disorders
Overt albuminuria
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 3
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
42.9%
3/7 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
5/7 • Number of events 5
|
|
Gastrointestinal disorders
Gastroparesis
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Bezoar
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
28.6%
2/7 • Number of events 2
|
|
Gastrointestinal disorders
Cholelithiasis
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Intrahepatic Biliary dilation
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Gastroenteritis
|
28.6%
2/7 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
14.3%
1/7 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
28.6%
2/7 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
42.9%
3/7 • Number of events 3
|
|
Infections and infestations
Otitis Media
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Dental Infection
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Urinary Tract infection
|
42.9%
3/7 • Number of events 4
|
|
Infections and infestations
EBV
|
28.6%
2/7 • Number of events 3
|
|
Infections and infestations
Lower leg infection
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia/arthritis
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Carpal Tunnel Syndrome
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Low Extremity Edema
|
28.6%
2/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Flu like symptoms
|
28.6%
2/7 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Upper Bronchiectasis
|
14.3%
1/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nodular Opacity
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Eye surgery
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Blurred Vision
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Weight gain
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Weight loss
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Increased LFT
|
42.9%
3/7 • Number of events 3
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
28.6%
2/7 • Number of events 2
|
Additional Information
Dr. Rodolfo Alejandro
University of Miami Miller School of Medicine Miami Fl
Phone: 305 243 5324
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place