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Clinical Islet Transplantation (CIT) CONFIDENTIAL Page 1 of 123
Protocol CIT-07
CLINICAL ISLET TRANSPLANTATION (CIT)
PROTOCOL CIT-07
Islet Transplantation in Type 1 Diabetes
Version 8.0 (20 August 2012)
BB-IND 9336
Study Sponsors:
The National Institute of Allergy and Infectious Diseases (NIAID)
The National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
CIT PRINCIPAL INVESTIGATORS MEDICAL MONITORS
Clinical Islet Transplantation (CIT) Consortium Nancy Bridges, MD
(as defined in RFA-DK-04-005) Chief, Transplantation Immunobiology Branch
Bernhard Hering, MD – University of Minnesota Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Xunrong Luo, MD, PhD – Northwestern University
Olle Korsgren, MD, PhD – Uppsala Univ. Hospital 6610 Rockledge Dr.; Room 6325
Nicole Turgeon, MD – Emory University Bethesda, MD 20892
Ali Naji, MD, PhD – University of Pennsylvania Phone: 301-451-4406
Andrew Posselt, MD, PhD – University of Fax: 301-402-2571
E-mail: nbridges@niaid.nih.gov
California, San Francisco
Camillo Ricordi, MD – University of Miami
James Shapiro, MD, PhD – University of Alberta Thomas L. Eggerman MD, PhD
Dixon Kaufman, MD, PhD, FACS - University of Director Islet Transplantation Program
Wisconsin Division of Diabetes, Endocrinology and Metabolic
Diseases
BIOSTATISTICIAN National Institute of Diabetes and Digestive and
William Clarke, PhD; CTSDMC Kidney Diseases
Department of Biostatistics 6707 Democracy Blvd. Rm 697 MSC5460
University of Iowa Bethesda, MD 20892 (overnight delivery 20817)
2400 UCC Phone: 301-594-8813
Iowa City, Iowa 52242 Fax: 301-480-3503
E-mail: eggermant@extra.niddk.nih.gov
Phone: 319-384-2833
Fax: 319-335-6535
E-mail: William-clarke@uiowa.edu
SENIOR REGULATORY OFFICER
PROJECT MANAGER Julia Goldstein, MD
Senior Regulatory Officer
Allison Priore, BS Division of Allergy, Immunology, and
Project Manager Transplantation
Division of Allergy, Immunology, and National Institute of Allergy and Infectious
Transplantation Diseases
National Institute of Allergy and Infectious 6610 Rockledge Dr. Rm 6717
Diseases Bethesda, MD 20892
6610 Rockledge Dr. Rm 6304B Phone: 301-451-3112
Bethesda, MD 20892 Fax: 301-480-1537
Phone: 301-560-4513 E-mail: goldsteinj@niaid.nih.gov
Fax: 301-402-2571
E-mail: priorea@niaid.nih.gov
Islet Transplantation in Type 1 Diabetes Version 8.0 (20 August 2012)
Clinical Islet Transplantation (CIT) CONFIDENTIAL Page 2 of 123
Protocol CIT-07
Confidentiality Statement
The information contained within this document is not to be disclosed in any way without prior permission of the
CIT PIs, the Division of Allergy, Immunology, and Transplantation, or the National Institute of Diabetes &
Digestive & Kidney Diseases.
Islet Transplantation in Type 1 Diabetes Version 8.0 (20 August 2012)
Clinical Islet Transplantation (CIT) CONFIDENTIAL Page 3 of 123
Protocol CIT-07
INVESTIGATOR SIGNATURE PAGE
Protocol Number: Version/Date: 8.0/ 20 August 2012
CIT-07
IND: CIT Principal Investigators:
BB-IND 9336 Bernhard Hering, MD; Xunrong Luo, MD, PhD; Olle Korsgren, MD, PhD;
Nicole Turgeon, MD; Ali Naji, MD, PhD ; Andrew Posselt, MD, PhD;
Camillo Ricordi, MD; James Shapiro, MD, PhD, Dixon Kaufman, MD, PhD,
FACS
Title:
Islet Transplantation in Type 1 Diabetes
Study Sponsors:
The National Institute of Allergy and Infectious Diseases (NIAID)
The National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
INSTRUCTIONS: Please have the Principal Investigator print, sign, and date at the indicated location
below. A copy should be kept for your records and the original signature page sent to the Data
Coordinating Center.
After signature, please return the original of this form by surface mail to:
ATTN: Clinical Trials Statistical & Data Management Center Department of Biostatistics
201 S Clinton St
Iowa City, IA 52240-4034
I confirm that I have read the above protocol in the latest version. I understand it, and I will work
according to the principles of Good Clinical Practice (GCP) as described in the United States Code of
Federal Regulations (CFR) – 21 CFR Parts 45, 50, 56, and 312, and the International Conference on
Harmonization (ICH) document “Guidance for Industry: E6 Good Clinical Practice: Consolidated
Guidance” dated April 1996. Further, I will conduct the study in keeping with local, legal, and
regulatory requirements.
As the Site Principal Investigator, I agree to conduct protocol CIT-07, “Islet Transplantation in Type 1
Diabetes” according to good clinical practices. I agree to carry out the study by the criteria written in the
protocol and understand that no changes can be made to this protocol without written permission of the
NIAID and NIDDK.
___________________________________
Site Principal Investigator (Print)
____________________________________ _________________
Site Principal Investigator (Signature) Date
Islet Transplantation in Type 1 Diabetes Version 8.0 (20 August 2012)
Clinical Islet Transplantation (CIT) CONFIDENTIAL Page 4 of 123
Protocol CIT-07
Protocol Synopsis
Title Islet Transplantation in Type 1 Diabetes
Clinical Phase Phase 3
IND Sponsor DAIT/NIAID/NIH
IND Number BB-IND 9336
Activation Date October 2006
Accrual Objective 48
Accrual Period 24 months
Follow-up Period 24 months after final transplant
Study Design A prospective, single-arm, multi-center study in islet transplantation
Treatment Description Subjects will receive up to 3 separate infusions of islets. Subjects will receive
induction and maintenance immunosuppression consisting of ATG
nd rd
(basiliximab instead of ATG for the 2 and 3 transplants, if applicable),
sirolimus and low-dose tacrolimus. In addition, subjects will receive
etanercept for anti-inflammatory therapy.
Primary Endpoint The proportion of subjects with an HbA1c <7.0% at Day 365 AND free of
severe hypoglycemic events from Day 28 to Day 365 inclusive following the
first islet transplant, with the day of transplant designated Day 0.
Secondary Endpoints The key secondary endpoints are the following:
1) The proportion of subjects with an HbA1c <7.0% AND free of severe
hypoglycemic events from Day 28 to Day 730, inclusive, after the first
islet transplant.
2) The proportion of subjects with HbA1c ≤ 6.5% at one year after the first
islet transplant AND free of severe hypoglycemic events from Day 28 to
Day 365 after the first islet transplant.
3) The proportion of subjects with HbA1c ≤ 6.5% at two years after the first
islet transplant AND free of severe hypoglycemic events from Day 28 to
Day 730 after the first islet transplant.
4) The proportion of subjects free of severe hypoglycemic events from Day
28 to Day 365 after the first islet transplant.
5) The proportion of subjects free of severe hypoglycemic events from Day
28 to Day 730 after the first islet transplant.
6) The proportion of subjects with HbA1c <7.0% at one year after the first
islet transplant.
7) The proportion of subjects with HbA1c <7.0% at two years after the first
islet transplant.
8) The proportion of subjects with HbA1c ≤6.5% at one year after the first
Islet Transplantation in Type 1 Diabetes Version 8.0 (20 August 2012)
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