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CITR Annual Report Exhibits. 2007 CITR Annual Report Exhibits Prepared by: CITR Coordinating Center The EMMES Corporation Rockville, MD Sponsored by: National Institute of Diabetes & Digestive & Kidney Diseases National Institutes of Health Bethesda, MD Datafile Closure: April 1, 2007.

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citr annual report exhibits
CITR Annual Report Exhibits

2007 CITR Annual ReportExhibitsPrepared by:CITR Coordinating CenterThe EMMES CorporationRockville, MDSponsored by:National Institute of Diabetes & Digestive & Kidney DiseasesNational Institutes of HealthBethesda, MDDatafile Closure: April 1, 2007

table of contents
Chapter 1: Islet Transplant Activity

Chapter 2: Recipient and Donor Characteristics

Chapter 3: Pancreas Procurement, Islet Processing and Infusion Characteristics

Chapter 4: Immunosuppression and Other Medications

Chapter 5: Graft Function

Chapter 6: Liver, Kidney, Lipid and PRA Effects

Chapter 7: Adverse Events

Chapter 8: Registry Data Quality Review

CITR Coordinating Center

CITR Committees

Table of Contents
islet transplant centers reporting data to citr participating north american centers 1999 2006
Islet Transplant Centers Reporting Data to CITR:Participating North American Centers 1999-2006

A - CITR Centers with at least one islet allograft infusion procedure conducted in 2006C - CITR Centers with no islet allograft infusions in 2006D - CITR Coordinating Center

slide5

Number of Islet Transplantation Centers Performing Islet Allografts per Year and Number with Data Entered in CITR Database All North American Islet Transplant Centers 1999-2006

slide6

Total Number of Islet Transplant Recipients, Recipients at CITR-Participating Centers, and Recipients with Detailed Data Reported to CITR By Year of First Islet Allograft InfusionAll North American Islet Transplant Centers 1999-2006

The Islet Transplant Summary (ITS) questionnaire is completed by all North American Islet Transplant Programs regardless of their participation in the Registry. Of 45 North American islet transplant programs polled, all have provided this information through 2006.

slide7

Total Number of Islet Allograft Infusion Procedures Performed and Number with Data Reported to CITR:CITR-Participating North American Islet Transplant Centers 1999-2006

slide8

Total Number (N=579) of Islet Allograft Infusion Procedures Conducted and Entered in CITR Database, by Year and Infusion Procedure Number:CITR-Participating North American and International Centers, 1999-2006

slide9

Total Number (N=579) of Islet Allograft Infusion Procedures Per Recipient:CITR-Participating North American and International Centers, 1999-2006

slide10
Islet Alone and Islet After Kidney Recipients:CITR-Participating North American and International Centers, 1999-2006
transplant recipient primary funding information citr participating us centers
Transplant Recipient Primary Funding InformationCITR-Participating US Centers
recipient demographics and characteristics at first infusion by total number of infusions received
Recipient Demographics and Characteristics at First Infusionby Total Number of Infusions Received
sirolimus trough level ng ml post last infusion all allograft recipients
Sirolimus Trough Level (ng/mL) Post Last InfusionAll Allograft Recipients

*Value of 61.8 ng/mL at Inf 3 Day 30 excluded from display.Verified correct by center, attributed to the participant taking Sirolimus shortly before sampling.

slide60
Total Number of Anti-Hypertensive Medications Pre Infusion and Post Last InfusionAll Allograft Recipients
slide62
Total Number of Lipid Lowering MedicationsPre Infusion and Post Last InfusionAll Allograft Recipients
slide66
Insulin Independence, Insulin Dependence, Absence of Fasting C-peptide, or Re-InfusionPost First InfusionA. Islet Alone Recipients

*C-peptide data not available at Day 75

**Year 3 status independent of re-infusion

slide67

Insulin Independence, Insulin Dependence, Absence of Fasting C-peptide, or Re-InfusionPost First InfusionB. Islet After Kidney Recipients

*C-peptide data not available at Day 75

**Year 3 status independent of re-infusion

slide68
Insulin Independence, Insulin Dependence or Absence of Fasting C-peptidePost Last InfusionA. Islet Alone Recipients
slide69
Insulin Independence, Insulin Dependence or Absence of Fasting C-peptidePost Last InfusionB. Islet After Kidney Recipients
slide70

Insulin Independence, Insulin Dependence, or Absence of Fasting C-peptidePost Last Infusion by Total Number of Infusions ReceivedIslet Alone RecipientsA. Recipients of 1 Infusion

slide71

Insulin Independence, Insulin Dependence, or Absence of Fasting C-peptidePost Last Infusion by Total Number of Infusions ReceivedIslet Alone RecipientsA. Recipients of 2 Infusions

slide72

Insulin Independence, Insulin Dependence, or Absence of Fasting C-peptidePost Last Infusion by Total Number of Infusions ReceivedIslet Alone RecipientsA. Recipients of 3 Infusions

slide74
Prevalence of Insulin Independence Post Last Infusion By Total Number of Infusions ReceivedIslet Alone Recipients
slide79
C-peptide  0.5 ng/mLA. Post First Infusion (Censored at Re-Infusion before Visit)Islet Alone Recipients
slide80
C-peptide  0.5 ng/mLA. Post First Infusion (Censored at Re-Infusion before Visit)Islet After Kidney Recipients
slide83
Severe HypoglycemiaA. Post First Infusion (Censored at Re-Infusion before Visit)Islet Alone Recipients
slide84
Severe HypoglycemiaB. Post First Infusion (Censored at Re-Infusion before Visit)Islet After Kidney Recipients
severe hypoglycemia e post last infusion islet alone recipients with detectable fasting c peptide
Severe HypoglycemiaE. Post Last InfusionIslet Alone Recipients with Detectable Fasting C-peptide

100

90

80

70

60

Percent of Recipients

50

40

30

20

10

0

Pre Inf 1

Day 30

Month 6

Year 1

Year 2

Year 3

N=92

N=254

N=219

N=177

N=115

N=75

Severe hypoglycemic episode

Missing data

slide88
Severe HypoglycemiaF. Post Last InfusionIslet Alone Recipients without Detectable Fasting C-peptide

100

90

80

70

60

Percent of Recipients

50

40

30

20

10

0

Pre Inf 1

Day 30

Month 6

Year 1

Year 2

Year 3

N=170

N=8

N=30

N=48

N=54

N=54

Severe hypoglycemic episode

Missing data

slide93
Persistence of Islet Graft Function by Ever Achieving Insulin IndependenceIslet Alone RecipientsNot Censored at Re-Infusion
slide94
Achievement of Insulin IndependenceA. All Allograft Recipients Post First Infusion(Not Censored at Re-Infusion)

Days Post First Infusion

Islet Alone

Islet After Kidney

Type of Allograft

slide95
Achievement of Insulin IndependenceB. Islet Alone Recipients Post First Infusion (Censored at Re-Infusion)
slide96

Achievement of Insulin IndependenceC. Islet Alone RecipientsPost Second Infusion (Recipients Not Insulin Independent after First Infusion, Censored at Third Infusion)

Days Post Second Infusion

N 158 76 54 46 35

slide97

Achievement of Insulin IndependenceD. Islet Alone RecipientsPost Third Infusion (Recipients Not Insulin Independent after First or Second Infusion, Censored at Fourth Infusion)

N 40 20 13 12 12

slide98

Persistence of Insulin Independence and Persistence of Graft FunctionIslet Alone Recipients Achieving Insulin IndependenceNot Censored at Re-Infusion

slide99

Persistence of Insulin IndependenceBy Total Number of Infusions Given Prior to Achievement of Insulin IndependenceIslet Alone Recipients Achieving Insulin Independence

composite outcome hypoglycemia and hba 1c post last infusion b islet after kidney recipients
Composite Outcome (Hypoglycemia and HbA1C) Post Last InfusionB. Islet After Kidney Recipients
slide102
Average Daily Insulin (Units) Taken By Recipients on Insulin Baseline and Post Last InfusionA. Islet Alone Recipients
slide103
Average Daily Insulin (Units) Taken By Recipients on Insulin Baseline and Post Last InfusionB. Islet After Kidney Recipients
slide104
Average Daily Insulin (Units/Kg) Taken By Recipients on InsulinBaseline and Post Last InfusionA. Islet Alone Recipients
slide105
Average Daily Insulin (Units/Kg) Taken By Recipients on InsulinBaseline and Post Last InfusionB. Islet After Kidney Recipients
slide106
Percent of Baseline Insulin Used By Recipients on InsulinFollow-Up Post Last InfusionA. Islet Alone Recipients
slide107
Percent of Baseline Insulin Used By Recipients on InsulinFollow-Up Post Last InfusionB. Islet After Kidney Recipients
slide108
Percent of Baseline Insulin at Follow-Up Post Last InfusionIslet Alone Recipients who Achieved then Lost Insulin Independence
slide109
Percent of Baseline Insulin at Follow-Up Post Last InfusionIslet Alone RecipientsNever Achieving Insulin Independence
slide110

Primary Outcomes Post First InfusionUp to Re-Infusion, Complete Islet Failure, or Last Follow-UpAccording to Pre-Infusion Recipient, Donor, Procurement, and Islet CharacteristicsIslet Alone Recipients

slide111

Primary Outcomes Post First InfusionUp to Re-Infusion, Complete Islet Failure, or Last Follow-UpAccording to Pre-Infusion Recipient, Donor, Procurement, and Islet CharacteristicsIslet Alone Recipients (continued)

slide112

Primary Outcomes Post First InfusionUp to Re-Infusion, Complete Islet Failure, or Last Follow-UpAccording to Pre-Infusion Recipient, Donor, Procurement, and Islet CharacteristicsIslet Alone Recipients (continued)

slide113
Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics
slide114
Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics(continued)
slide115
Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics (continued)
slide116
Primary Outcomes Post Last InfusionAccording to Pre-Infusion Recipient, Donor, Procurement, and Islet Characteristics (continued)
fasting plasma glucose mg dl pre infusion and post last infusion
Fasting Plasma Glucose (mg/dL)Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

hba 1c pre infusion and post last infusion
HbA1C (%)Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

basal plasma c peptide ng ml pre infusion and post last infusion
Basal Plasma C-Peptide (ng/mL)Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

slide120
Fasting Plasma Glucose (mg/dL)Pre Infusion and Post Last InfusionIslet Alone Recipients with One Infusion
slide122
Basal Plasma C-Peptide (ng/mL)Pre Infusion and Post Last InfusionIslet Alone Recipients with One Infusion
slide123
Fasting Plasma Glucose (mg/dL)Pre Infusion and Post Last InfusionIslet Alone Recipients with Two Infusions
slide125
Basal Plasma C-Peptide (ng/mL)Pre Infusion and Post Last InfusionIslet Alone Recipients with Two Infusions
slide126
Fasting Plasma Glucose (mg/dL)Pre Infusion and Post Last InfusionIslet Alone Recipients with Three Infusions
slide128
Basal Plasma C-Peptide (ng/mL)Pre Infusion and Post Last InfusionIslet Alone Recipients with Three Infusions
fasting plasma glucose mg dl post last infusion recipients who ever achieved insulin independence
Fasting Plasma Glucose (mg/dL) Post Last InfusionRecipients Who Ever Achieved Insulin Independence

A. Islet Alone Recipients

B. Islet After Kidney Recipients

fasting plasma glucose mg dl post last infusion recipients who never achieved insulin independence
Fasting Plasma Glucose (mg/dL) Post Last InfusionRecipients Who Never Achieved Insulin Independence

A. Islet Alone Recipients

B. Islet After Kidney Recipients

hba 1c post last infusion recipients who ever achieved insulin independence
HbA1C (%) Post Last InfusionRecipients Who Ever Achieved Insulin Independence

A. Islet Alone Recipients

B. Islet After Kidney Recipients

hba 1c post last infusion recipients who never achieved insulin independence
HbA1C (%) Post Last InfusionRecipients Who Never Achieved Insulin Independence

A. Islet Alone Recipients

B. Islet After Kidney Recipients

basal plasma c peptide ng ml post last infusion recipients who ever achieved insulin independence
Basal Plasma C-Peptide (ng/mL) Post Last InfusionRecipients Who Ever Achieved Insulin Independence

A. Islet Alone Recipients

B. Islet After Kidney Recipients

basal plasma c peptide ng ml post last infusion recipients who never achieved insulin independence
Basal Plasma C-Peptide (ng/mL) Post Last InfusionRecipients Who Never Achieved Insulin Independence

A. Islet Alone Recipients

B. Islet After Kidney Recipients

fasting plasma glucose mg dl pre and post first infusion insulin independent recipients
Fasting Plasma Glucose (mg/dL) Pre and Post First InfusionInsulin Independent Recipients

A. Islet Alone Recipients

B. Islet After Kidney Recipients

fasting plasma glucose mg dl pre and post first infusion insulin dependent recipients
Fasting Plasma Glucose (mg/dL) Pre and Post First InfusionInsulin Dependent Recipients

A. Islet Alone Recipients

B. Islet After Kidney Recipients

hba 1c pre and post first infusion insulin independent recipients
HbA1C (%) Pre and Post First InfusionInsulin Independent Recipients

A. Islet Alone Recipients

B. Islet After Kidney Recipients

hba 1c pre and post first infusion insulin dependent recipients
HbA1C (%) Pre and Post First InfusionInsulin Dependent Recipients

A. Islet Alone Recipients

B. Islet After Kidney Recipients

basal plasma c peptide ng ml pre and post first infusion insulin independent recipients
Basal Plasma C-Peptide (ng/mL) Pre and Post First InfusionInsulin Independent Recipients

A. Islet Alone Recipients

B. Islet After Kidney Recipients

basal plasma c peptide ng ml pre and post first infusion insulin dependent recipients
Basal Plasma C-Peptide (ng/mL) Pre and Post First InfusionInsulin Dependent Recipients

A. Islet Alone Recipients

B. Islet After Kidney Recipients

slide141
Recipients with Fasting Blood Glucose  126 mg/dLPost Last Infusion by Insulin StatusA. Islet Alone Recipients
slide142
Recipients with Fasting Blood Glucose  126 mg/dLPost Last Infusion by Insulin StatusB. Islet After Kidney Recipients
slide143
Insulin Dependent Recipients with Basal C-Peptide  0.5 ng/mLPost Last InfusionA. Islet Alone Recipients
slide144
Insulin Dependent Recipients with Basal C-Peptide  0.5 ng/mLPost Last InfusionB. Islet After Kidney Recipients
recipients with hba 1c 6 5 post last infusion by insulin status b islet after kidney recipients
Recipients with HbA1C < 6.5%Post Last Infusion by Insulin StatusB. Islet After Kidney Recipients
slide152
Secondary Complications of DiabetesPre First Infusion and Post Last InfusionAll Allograft Recipients
slide153
Secondary Complications of DiabetesPre First Infusion and Post Last InfusionAll Allograft Recipients (continued)
slide154
Secondary Complications of DiabetesPre First Infusion and Post Last InfusionAll Allograft Recipients (continued)
slide155
Secondary Complications of DiabetesPre First Infusion and Post Last InfusionAll Allograft Recipients (continued)
ocular complications pre first infusion and post last infusion all allograft recipients continued
Ocular ComplicationsPre First Infusion and Post last InfusionAll Allograft Recipients (continued)
slide159
Incidence of Abnormal Liver Function Testsat Any Scheduled Time Post First InfusionAll Allograft Recipients
alt iu l pre infusion and post last infusion
ALT (IU/L) Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

ast iu l pre infusion and post last infusion
AST (IU/L) Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

alkaline phosphatase iu l pre infusion and post last infusion
Alkaline Phosphatase (IU/L) Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

total bilirubin mg dl pre infusion and post last infusion
Total Bilirubin (mg/dL) Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

total cholesterol mg dl pre infusion and post last infusion
Total Cholesterol (mg/dL) Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

hdl mg dl pre infusion and post last infusion
HDL (mg/dL) Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

ldl mg dl pre infusion and post last infusion
LDL (mg/dL) Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

triglycerides mg dl pre infusion and post last infusion
Triglycerides (mg/dL) Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

slide169

Incidence of Increase in Serum Creatinine (mg/dL) Greater than 0.5 from Baselineat Any Scheduled Time Post First InfusionAll Allograft Recipients

serum creatinine mg dl pre infusion and post last infusion
Serum Creatinine (mg/dL) Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

calculated creatinine clearance ml min 1 73m 2 pre infusion and post last infusion
Calculated Creatinine Clearance (mL/min/1.73m2)Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

gfr ml min 1 73m 2 pre infusion and post last infusion
GFR (mL/min/1.73m2)Pre Infusion and Post Last Infusion

A. Islet Alone Recipients

B. Islet After Kidney Recipients

slide174
Change in Class I PRA from Pre First InfusionPre Subsequent Infusion and Post Last Infusion Islet Alone Recipients
slide178
Percent of Recipients with an Adverse Event (AE) or Serious Adverse Event (SAE)in Year 1 Post First Infusion
slide180
Percent of Recipients with a Serious Adverse Eventin Year 1 Post First Infusion by Year of First InfusionAll Allograft Recipients
slide183
Serious Adverse Events MedDRA System/Organ Classby Relatedness to Islet Infusion or Immunosuppression
slide184
Serious Adverse Events MedDRA System/Organ Classby Relatedness to Islet Infusion or Immunosuppression(continued)
slide187
Most Common Serious Adverse Events Reported Within One Year of Any InfusionAll Allograft Recipients
slide188
Most Common Serious Adverse Events Reported More than One Year after Any InfusionAll Allograft Recipients
listing of reported hemorrhages and portal vein thromboses all allograft recipients
Listing of Reported Hemorrhages and Portal Vein ThrombosesAll Allograft Recipients
listing of reported hemorrhages and portal vein thromboses all allograft recipients continued
Listing of Reported Hemorrhages and Portal Vein ThrombosesAll Allograft Recipients (continued)
listing of reported hemorrhages and portal vein thromboses all allograft recipients continued192
Listing of Reported Hemorrhages and Portal Vein ThrombosesAll Allograft Recipients (continued)
slide193
Number of Days Hospitalized at Infusion (from Admission to Discharge)by Infusion SequenceIslet Alone Recipients
slide194
Number of Days Hospitalized at Infusion (from Admission to Discharge)by Infusion SequenceIslet After Kidney Recipients
slide195
Hospitalization Experienced Post Last Infusion by Total Number of Infusions ReceivedIslet Alone Recipients
slide196
Hospitalization Experienced Post Last Infusion by Total Number of Infusions ReceivedIslet After Kidney Recipients
citr coordinating center july 2006 july 2007
CITR Coordinating Center(July 2006 – July 2007)

PI: Franca Barton

Co-PI: Donald Stablein

Matthew Beyers

Bryan Calaway

Yamini Damodharan

Krista Huang

Jessica Long

Glenn Tucker

Chuck Wagner

Steve Wease

citr committees
Scientific Advisory Committee (SAC)

Compliance Committee

Data Elements Committee

Publications/Presentations Committee

Transplant Coordinators’/Data Managers’ Committee

CITR Committees
citr scientific advisory committee sac
Chair: Bernhard J. Hering

Michael Cecka

Philip Cryer

Mary D. Ellison

Olle Korsgren

Jerry P. Palmer

Camillo Ricordi

CITR Scientific Advisory Committee (SAC)
citr compliance committee
Michael Appel

Parastoo Dinyari

E. Brian Flanagan

Fouad Kandeel

Eileen M. Markmann

Jamen Parkey

Marti Sears

Elyse Stuart

CITR Compliance Committee
citr data elements committee
Chair: Marc Garfinkel

David Baidal

Enrico Cagliero

Fouad Kandeel

Dixon Kaufman

Melissa Roberts

Marti Sears

CITR Data Elements Committee
citr publications presentations committee
Chair: Rodolfo Alejandro

Michael Appel

Nancy Bridges

Elizabeth Holbrook

Ali Naji

Bashoo Naziruddin

Craig Smith

CITR Publications/Presentations Committee
citr transplant coordinators data managers committee
Chair: Melissa Roberts

Jarrett Anderson

Shama Bader

David Baidal

LeAnn Batterson

Jennifer Bishop

Parastoo Dinyari

Jane Fasbender

Beverly Fleckton

Charlotte Garwood

Susan George

Debbie Grice

Darrell Grimes

Jeannette Hacker

Michael Hanschew

Celia Hartigan

CITR Transplant Coordinators’/Data Managers’ Committee

Nancy Radke

Violeta Raverdy

Marilyn Reeve

Payam Salehi

Ammar Saoud

Grace Sauzier

Marti Sears

Jill Sheedy

KD Shiang

Elyse Stuart

Joanna Sung

Pat Swanson

Shameka Thomas

Heather Turgeon

Piotr Witkowski

Robin Jevne

Jenny Joseph

Debra Kemp

Carol Kramer

Arlene LaRose

Mark Lockwood

Eileen Markmann

Joan Martellotto

Marli McCulloch-Olson

Joan McElroy

Melissa McGraw

Suzanne Miller

Bashoo Naziruddin

Lori Otken

Maral Palanjian

Jamen Parkey