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Persons using assistive technology may not be able to fully access information in this file. For assistance, e-mail niddk-cr@imsweb.com. Include the Web site and filename in your message. 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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