CITR Annual Report Exhibits CITR Annual Report Exhibits Prepared by: CITR Coordinating Center The EMMES Corporation Rockville, MD Sponsored by: National

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 Age (yrs)

Donor Weight (kg)

Donor Body Mass Index (kg/m2)

Time from Cross Clamp toPancreas Recovery (mins)

Donor Characteristics: Use of Vasopressors

Donor Serology

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)

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


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


Participants with One Infusion



Basal Plasma C-peptide (ng/mL) Pre Infusionand Post Last Infusion



Participants with Two Infusions






Participants with Three Infusions

HbA1C (%) Pre Infusion and Post Last Infusion Participants with Three Infusions


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


HbA1C (%) Pre First Infusion and Post First Infusion


Basal Plasma C-peptide (ng/mL) Pre First Infusionand Post First Infusion


Basal Plasma C-peptide (ng/mL) Pre First Infusionand Post First Infusion


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)







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 Age (yrs)

Donor Weight (kg)

Donor Body Mass Index (kg/m2)

Time from Cross Clamp to Pancreas Recovery (mins)

Donor Characteristics: Use of Vassopressors

Donor Serology

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


Average Daily Insulin Use (Units) at Follow-UpPost Last Infusion


Summary of Severe Hypoglycemic Eventsby Pre First Infusion and Follow-Up 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


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

Documents

CITR Annual Report Exhibits CITR Annual Report Exhibits Prepared by: CITR Coordinating Center The EMMES Corporation Rockville, MD Sponsored by: National