CITR Annual Report ExhibitsCITR Annual ReportExhibits
Prepared by:
CITR Coordinating CenterThe EMMES Corporation
Rockville, MD
Sponsored by:National Institute of Diabetes & Digestive & Kidney Diseases
National Institutes of HealthBethesda, MD
Datafile Closure: April 1, 2005
Table of Contents
Section 1: Registry Summary
Section 2: Islet Transplant Alone Information
Chapter 1: Recipient and Donor Characteristics
Chapter 2: Pancreas Procurement and Islet Processing
Chapter 3: Immunosuppressive and Other Medications
Chapter 4: Graft Function
Chapter 5: Recipient’s Laboratory Data
Chapter 6: Adverse Events
Section 3: Islet After Kidney Transplant Information
CITR Coordinating Center
CITR Committees
Section 1: Registry Summary
Contributing Islet Transplant Centers* (N=19)
Summary of Information Representedin CITR Annual Reports
Number of Islet Transplant Programs Transplanting and Number Reporting to CITR by Year
Total Number of Infusion Procedures Conducted and Entered in CITR Database by Year and by
Infusion Number (All Participants, N=138)
Total Number of Infusion ProceduresReceived Per Recipient (All Participants, N=138)
Summary of Transplant Types (All Participants, N=138)
Summary of Information for Islet Transplant Alone Recipients
Total Number of Islet Infusions Received forIslet Transplant Alone Recipients (N=118)
Summary of Information for Islet After Kidney Recipients
Total Number of Islet Infusions Received forIslet After Kidney Recipients (N=19)
Section 2: Islet Transplant Alone Information
Chapter 1: Recipient and Donor Characteristics
Recipient Demographics
Recipient Characteristics
Recipient’s Primary Payer and Employment Status at Time of First Infusion
Recipient Status at First Infusion
Recipient Status at First Infusion(continued)
Recipient Summary Measures at First Infusion
Recipient Serology at Screening
Infusion Summary by Infusion Sequence
Donor Characteristics
Donor Characteristics and HospitalizationSummary Information
Donor Characteristics and HospitalizationSummary Information (continued)
Donor Characteristics and HospitalizationSummary Information (continued)
Donor Characteristics and HospitalizationSummary Information (continued)
Donor Weight (kg)
Donor Body Mass Index (kg/m2)
Time from Cross Clamp toPancreas Recovery (mins)
Donor Characteristics: Use of Vasopressors
Donor Laboratory Data
Donor Serum Creatinine (mg/dL)
Donor BUN (mg/dL)
Donor Total Bilirubin (mg/dL)
Donor Serum Lipase (IU/L)
Donor Serum Amylase (IU/L)
Donor Pre-Insulin Blood Glucose (mg/dL)
Donor Maximum Blood Glucose (mg/dL)
Chapter 2: Pancreas Procurement and Islet Processing
Islet Processing Summary
Islet Processing Summary (continued)
Cold Ischemia Information
Summary of Islet Equivalents and Timing of Count
Islet Product Characterization
Total Islet Equivalents by Cold Ischemic Time
Total Islet Equivalents by Donor Body Mass Index
Total Islet Equivalents by Donor Age
Islet Characteristics by Time from CrossClamp to Pancreas Recovery
Islet Characteristics by Pancreas Preservation Method
Islet Characteristics by Cold Ischemic Time
Islet Characteristics by Donor Age
Islet Characteristics by Donor Body Mass Index
Mean Number of Islet Equivalents/kg ( SD) by Total Number of Infusions Received
(Recipients with a Total of 1 Infusion, 2 Infusions, and 3 Infusions)
Chapter 3: Immunosuppressive and Other Medications
Immunosuppression Regimen at Time of First Infusion
Immunosuppression Dosing (mg/day) at Time of Infusion by Infusion Sequence
Induction Therapy (mg) at Time of Infusionby Infusion Sequence
Percentage (%) of First Infusions Using T Cell Antibodies for Induction Therapy
Immunosuppression Therapy Use Post Last Infusion
Immunosuppression Dosing (mg/day) Post Last Infusion
Sirolimus Trough Level (ng/mL) Post Last Infusion
Tacrolimus Trough (ng/mL) Level Post Last Infusion
Use of Anti-Hypertensive Medications at Pre Infusion and Post Last Infusion
Percent of Participants Using Anti-Hypertensive Medications at Pre Infusion and Post Last Infusion
Use of Lipid Lowering Medications Pre Infusion and Post Last Infusion
Percent of Participants Using of Lipid Lowering Medications at Pre Infusion and Post Last Infusion
Adjunctive Therapy at Time of First Infusion
Chapter 4: Graft Function
Insulin Status (%) at Recipient’s Last Follow-upPost Last Infusion
Insulin Independence Rates (%) by Total Number of Infusions and Follow-up Post Last Infusion
Insulin Status (%) by Follow-up Visit Post Last Infusion
Time to First Occurrence of Insulin Use Post Last Infusion
Time to First Occurrence of Insulin Use Post Last Infusion by Total Number of Infusions
Percent of Insulin Independent Participants Post Last Infusion
Cohort of Recipients Followed by Insulin StatusPost First Infusion
Cohort of Recipients Followed by Insulin StatusPost Last Infusion
Reduction of Insulin (%) Pre Infusion to Follow-Up Post Last Infusion
Participants on Insulin
Average Daily Insulin Use (Units) at Follow-Up Post Last Infusion
Participants on Insulin
Insulin Independence (%) Month 6 Post First First Infusionby Participant’s Age (yrs)
Insulin Independence (%) Month 6 Post First First Infusion by Participant’s Duration of Diabetes (yrs)
Insulin Independence (%) Month 6 Post First First Infusionby Participant’s Weight (kg)
Insulin Independence (%) Month 6 Post First First Infusionby Participant’s Body Mass Index (kg/m2)
Insulin Independence (%) Month 6 Post First First Infusionby Participant’s Average Daily Insulin Use (Units/Day)
Insulin Independence (%) Month 6 Post First First Infusionby Participant’s Average Daily Insulin Use (Units/Day/kg)
Summary of Severe Hypoglycemic Events Pre FirstInfusion and Follow-Up Post Last Infusion
Insulin Status at Post Last Infusion Follow-Up andSirolimus Trough Levels (ng/mL)
Insulin Status at Post Last Infusion Follow-Up and Tacrolimus Trough Levels (ng/mL)
Fasting Plasma Glucose (mg/dL) Pre Infusionand Post Last Infusion
HbA1C (%) Pre Infusion and Post Last Infusion
Basal Plasma C-Peptide (ng/mL) Pre Infusionand Post Last Infusion
Fasting Plasma Glucose (mg/dL) Pre Infusionand Post Last Infusion
Participants with One Infusion
HbA1C (%) Pre Infusion and Post Last Infusion
Participants with One Infusion
Basal Plasma C-peptide (ng/mL) Pre Infusionand Post Last Infusion
Participants with One Infusion
Fasting Plasma Glucose (mg/dL) Pre Infusionand Post Last Infusion
Participants with Two Infusions
HbA1C (%) Pre Infusion and Post Last Infusion
Participants with Two Infusions
Basal Plasma C-peptide (ng/mL) Pre Infusionand Post Last Infusion
Participants with Two Infusions
Fasting Plasma Glucose (mg/dL) Pre Infusionand Post Last Infusion
Participants with Three Infusions
HbA1C (%) Pre Infusion and Post Last Infusion Participants with Three Infusions
Basal Plasma C-peptide (ng/mL) Pre Infusionand Post Last Infusion
Participants with Three Infusions
Fasting Plasma Glucose (mg/dL) Pre First Infusionto Post First Infusion
Insulin Independent Participants
Fasting Plasma Glucose (mg/dL) Pre First Infusionto Post First Infusion
Insulin Dependent Participants
HbA1C (%) Pre First Infusion and Post First Infusion
Insulin Independent Participants
HbA1C (%) Pre First Infusion and Post First Infusion
Insulin Dependent Participants
Basal Plasma C-peptide (ng/mL) Pre First Infusionand Post First Infusion
Insulin Independent Participants
Basal Plasma C-peptide (ng/mL) Pre First Infusionand Post First Infusion
Insulin Dependent Participants
Pre Infusion Recipient Lab Summary by Infusion Sequence
Metabolic Summary by Follow-Up Post Last Infusion
Metabolic Summary by Month 6 Post Last Infusionby Insulin Status
Metabolic Summary Year 1 Post Last Infusionby Insulin Status
Islet Graft Dysfunction and Recipient Survival Summary Post Last Infusion
Islet Graft Dysfunction (IGD) Summary
Pre Infusion Recipient Lab Summary by Infusion SequenceParticipants with Islet Graft Dysfunction
Summary of Secondary Complications Pre First Infusion and Post Last Infusion
Summary of Secondary Complications Pre First Infusion and Post Last Infusion (continued)
Summary of Secondary Complications Pre First Infusion and Post Last Infusion (continued)
Summary of Ocular Complications Post Last Infusion
Chapter 5: Recipient’s Laboratory Data
Participants with Abnormal Liver Function Tests Post Infusion
ALT (IU/L) Pre Infusion and Post Last Infusion
AST (IU/L) Pre Infusion and Post Last Infusion
Alkaline Phosphatase (IU/L) Pre Infusion and Post Last Infusion
Total Bilirubin (mg/dL) Pre Infusion and Post Last Infusion
Participants with Abnormal Lipid Tests Post Infusion
Total Cholesterol (mg/dL) Pre Infusion and Post Last Infusion
HDL (mg/dL) Pre Infusion and Post Last Infusion
LDL (mg/dL) Pre Infusion and Post Last Infusion
Triglycerides (mg/dL) Pre Infusion and Post Last Infusion
Percent of Participants with an Increase in Serum Creatinine (mg/dL) Greater than 0.5 from Baseline
Serum Creatinine (mg/dL) Pre Infusion and Post Last Infusion
Calculated Creatinine Clearance (mL/min/1.73m2)Pre Infusion and Post Last Infusion
Chapter 6: Adverse Events
Summary of Adverse Events and Serious Adverse Events in Year 1 Post First Infusion (Participants, N=83)
Number of Recipients with Reported Adverse Events and Serious Adverse Events Following First Infusion by Visit
Month
Summary of All Serious Adverse Events (SAEs) Reported by Type of SAE
Summary of All Serious Adverse Events (SAEs) Reported and Relationship to Islet Infusion Procedure
Summary of All Serious Adverse Events (SAEs) Reported and Relationship to Immunosuppression Therapy
Summary of All Serious Adverse Events (SAEs) Reported and Outcome
Summary of All Serious Adverse Events (SAEs) Reported by System Organ Class
All Serious Adverse Events (SAEs) Reported in Alphabetical Order
All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued)
All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued)
All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued)
All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued)
All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued)
All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued)
All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued)
Number of Days Hospitalized at Infusion (Admission to Discharge) by Infusion Sequence
Hospitalizations Experienced Post Last Infusion by Total Number of Infusions Received
Changes in Portal Pressure (mmHg) and Infusion Summary by Infusion Sequence
Pre Infusion Portal Pressure (mmHg) by Infusion Sequence
Peak Portal Pressure (mmHg) by Infusion Sequence
Closure Portal Pressure (mmHg)by Infusion Sequence
Change from Pre Infusion to Closure Portal Pressure (mmHg) by Infusion Sequence
Change from Pre Infusion to Peak Portal Pressure (mmHg) by Infusion Sequence
Section 3: Islet After Kidney Transplant Information
Recipient Demographics
Recipient Characteristics
Recipient’s Primary Payer and Employment Status at Time of First Infusion
Recipient Status at First Infusion
Recipient Status at First Infusion (continued)
Recipient Summary Measures at First Infusion
Recipient Serology at Screening
Infusion Summary by Infusion Sequence
Donor Characteristics
Donor Characteristics and HospitalizationSummary Information
Donor Characteristics and HospitalizationSummary Information (continued)
Donor Characteristics and HospitalizationSummary Information (continued)
Donor Characteristics and HospitalizationSummary Information (continued)
Donor Weight (kg)
Donor Body Mass Index (kg/m2)
Time from Cross Clamp to Pancreas Recovery (mins)
Donor Characteristics: Use of Vassopressors
Donor Laboratory Data
Donor Serum Creatinine (mg/dL)
Donor BUN (mg/dL)
Donor Total Bilirubin (mg/dL)
Donor AST (IU/L)
Donor ALT (IU/L)
Donor Serum Lipase (IU/L)
Donor Serum Amylase (IU/L)
Donor Pre-Insulin Blood Glucose (mg/dL)
Donor Maximum Blood Glucose (mg/dL)
Islet Processing Summary
Islet Processing Summary (continued)
Pancreas Procurement Information
Summary of Islet Equivalents and Timing of Count
Islet Product Characterization
Mean Number of Islet Equivalents/kg (SD) by Total Number of Infusions Received
(Recipients with a Total of 1 Infusion and 2 Infusions)
Immunosuppression Regimen at Time of First Infusion
Immunosuppression Dosing (mg/day) at Time of Infusion by Infusion Sequence
Induction Therapy (mg) at Time of Infusion by Infusion Sequence
Immunosuppression Therapy Use Post Last Infusion
Immunosuppressive Dosing (mg/day) Post Last Infusion
Sirolimus Trough (ng/mL) Level Post Last Infusion
Tacrolimus Trough (ng/mL) Level Post Last Infusion
Cohort of Recipients Followed by Insulin StatusPost First Infusion
Cohort of Recipients Followed by Insulin StatusPost Last Infusion
Reduction of Insulin (%) from Pre Infusion toFollow-Up Post Last Infusion
Participants on Insulin
Average Daily Insulin Use (Units) at Follow-UpPost Last Infusion
Participants on Insulin
Summary of Severe Hypoglycemic Eventsby Pre First Infusion and Follow-Up Post Last Infusion
Fasting Plasma Glucose (mg/dL) Pre Infusionand Post Last Infusion
HbA1C (%) Pre Infusion and Post Last Infusion
Basal Plasma C-peptide (ng/mL) Pre Infusionand Post Last Infusion
Pre Infusion Recipient Lab Summaryby Infusion Sequence
Participants with Abnormal Liver FunctionTests Post Infusion
ALT (IU/L) Pre Infusion and Post Last Infusion
AST (IU/L) Pre Infusion and Post Last Infusion
Alkaline Phosphatase (IU/L) Pre Infusionand Post Last Infusion
Total Bilirubin (mg/dL) Pre Infusion and Post Last Infusion
Participants with Abnormal Lipid Tests Post Infusion
Total Cholesterol (mg/dL) Pre Infusionand Post Last Infusion
HDL (mg/dL) Pre Infusion and Post Last Infusion
LDL (mg/dL) Pre Infusion and Post Last Infusion
Triglycerides (mg/dL) Pre Infusion and Post Last Infusion
Percent of Participants with an Increase in Serum Creatinine (mg/dL) Greater than 0.5 from Baseline
Serum Creatinine (mg/dL) Pre Infusionand Post Last Infusion
Calculated Creatinine Clearance (mL/min/1.73m2) Pre Infusion and Post Last Infusion
Summary of Adverse Events and Serious Adverse Eventsin Year 1 Post First Infusion (Participants, N=19)
Number of Recipients with Reported Adverse Events and Serious Adverse Events Following First Infusion by Visit
Month
Summary of All Serious Adverse Events (SAEs)by Type of SAE
Summary of All Serious Adverse Events (SAEs)and Relationship to Islet Infusion Procedure
Summary of All Serious Adverse Events (SAEs)and Relationship to Immunosuppression Therapy
Summary of All Serious Adverse Events (SAEs)and Outcome
Summary of All Serious Adverse Events (SAEs)by System Organ Class
All Serious Adverse Events (SAEs) Reported in Alphabetical Order
All Serious Adverse Events (SAEs) Reported in Alphabetical Order (continued)
Number of Days Hospitalized at Infusion(Admission to Discharge) by Infusion Sequence
Hospitalizations Experienced Post Last Infusionby Total Number of Infusions Received
Changes in Portal Pressure (mmHg) and Infusion Summaryby Infusion Sequence
CITR Coordinating Center
Director: Nicole Close
Lisa Davis
Devin Hunt
Omid Neyzari
Donald Stablein
Steve Wease
CITR Committees
Scientific Advisory Committee (SAC)
Compliance Committee
Data Monitoring Committee
Publications/Presentations Committee
Transplant Coordinators’/Data Managers’ Committee
CITR Scientific Advisory Committee (SAC)
Chair: Bernhard J. Hering
Reinhard G. Bretzel
Michael Cecka
Mary D. Ellison
Jerry P. Palmer
Camillo Ricordi
A.M. James Shapiro
CITR Compliance Committee
Michael Appel
E. Brian Flanagan
Fouad Kandeel
Eileen M. Markmann
David Radosevich
Marti Sears
Elyse Stuart
CITR Data Monitoring Committee
Chair: Marc Garfinkel
David Baidal
Enrico Cagliero
Fouad Kandeel
Dixon Kaufman
Jeff Longmate
Melissa Roberts
Marti Sears
CITR Publications/Presentations Committee
Chair: Rodolfo Alejandro
Michael Appel
Nancy Bridges
Elizabeth Holbrook
Ali Naji
A.M. James Shapiro
Craig Smith
CITR Transplant Coordinators’/Data Managers’ Committee
Chair: Eileen Markmann
David Baidal
Susan Comninel
Barbara Culbreath
Arthur Dea
Parastoo Dinyari
Cheryl Durkop
Celia Hartigan
Elizabeth Holbrook
Debra Kemp
Kathleen LaBranche
Lorraine Lesiecki
Marli McCulloch-Olsen
Maral Palanjian
Jamen Parkey
Melissa Roberts
Grace Sauzier
Marti Sears
KD Shiang
Winsor Simmons
Elyse Stuart
Heather Turgeon
Terri Wakefield
Elizabeth Wright
Tiffany Zgabay
Dylan Zylla