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Clinical Protocol ZS-004 Clinical Protocol ZS-004 A Phase 3 Multicenter, Multi-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-controlled Maintenance Study to Investigate the Safety and Efficacy of ZS (Microporous, Fractionated, Protonated Zirconium Silicate), an Oral Sorbent, in Subjects with Hyperkalemia. IND 108951 SPONSOR ZS Pharma, Inc. 508 Wrangler Drive, Suite 100 Coppell TX 75019 Original Protocol: 8 July 2013 Amendment 1: 23 December 2013 Amendment 2: 24 February 2014 Amendment 3: 14 April 2014 CONFIDENTIALITY STATEMENT Part or all of the information in this protocol may be unpublished material. Accordingly, this protocol is to be treated as confidential and restricted to its intended use. This material is the property of ZS Pharma, Inc. and must not be disclosed or used except as authorized in writing by ZS Pharma, Inc. Downloaded From: https://jamanetwork.com/ on 10/02/2021 Protocol Number ZS-004 (Amendment 3) Date: 14 April 2014 Table of Contents 1 STUDY TITLE ........................................................................................................... 5 2 SPONSOR INFORMATION ..................................................................................... 5 2.1 Sponsor: .............................................................................................................. 5 2.2 Sponsor Representative:...................................................................................... 5 3 LIST OF ABBREVIATIONS ..................................................................................... 6 4 STUDY SYNOPSIS ................................................................................................... 9 5 Events Schedule: Phase 3 Dose-ranging Efficacy and Safety Study Against Placebo 19 5.1 Open-Label Acute Phase (AP) – All Sites ........................................................ 19 5.1.1 Open-Label Acute Phase (AP)- North American Sites ONLY .................... 20 5.2 DB Randomized Maintenance Phase (DBRMP)- All Sites .............................. 21 5.2.1 DB Randomized Maintenance Phase (DBRMP) - North American Sites ONLY 22 6 INTRODUCTION .................................................................................................... 23 7 BACKGROUND ...................................................................................................... 24 8 STUDY OBJECTIVES ............................................................................................. 35 8.1 Primary Objective ............................................................................................. 35 8.2 Additional Objectives ....................................................................................... 35 9 INFORMED CONSENT .......................................................................................... 36 10 STUDY POPULATION ........................................................................................... 36 10.1 Inclusion Criteria .............................................................................................. 36 10.2 Exclusion Criteria ............................................................................................. 37 10.3 Design ............................................................................................................... 37 10.3.1 Stopping Rules .......................................................................................... 40 10.3.2 Dose Adjustment ....................................................................................... 41 10.4 Recordkeeping and Monitoring ........................................................................ 41 10.5 Investigational Supplies .................................................................................... 41 10.5.1 Study Drug Description ............................................................................ 41 10.5.2 Packaging .................................................................................................. 42 10.5.3 Investigational Product (IP) Dispensing ................................................... 42 10.5.4 Dosage Preparation and Administration ................................................... 42 10.5.5 Storage Requirements ............................................................................... 43 10.5.6 Investigational Product Accountability ..................................................... 43 10.5.7 Retrieval and Destruction ......................................................................... 43 10.6 Randomization and Blinding ............................................................................ 43 10.7 Study Visits ....................................................................................................... 44 10.7.1 General Information .................................................................................. 44 10.7.2 AP Study Day 1 ........................................................................................ 46 10.7.3 AP Study Day 2 ........................................................................................ 48 10.7.4 AP Study Day 3 ........................................................................................ 48 10.7.5 DBRMP Study Day 1................................................................................ 49 10.7.6 DBRMP Study Day 2................................................................................ 50 10.7.7 DBRMP Study Day 5................................................................................ 50 10.7.8 DBRMP Study Day 8................................................................................ 51 10.7.9 DBRMP Study Day 12.............................................................................. 51 CONFIDENTIAL Page 2 of 77 Downloaded From: https://jamanetwork.com/ on 10/02/2021 Protocol Number ZS-004 (Amendment 3) Date: 14 April 2014 10.7.10 DBRMP Study Day 15.............................................................................. 52 10.7.11 DBRMP Study Day 19.............................................................................. 52 10.7.12 DBRMP Study Day 22.............................................................................. 53 10.7.13 DBRMP Study Day 26.............................................................................. 53 10.7.14 DBRMP Study Day 29.............................................................................. 54 10.7.15 End of Study Visit ..................................................................................... 55 10.8 Clinical Laboratory Evaluations ....................................................................... 56 10.8.1 Blood chemistry and hematology ............................................................. 56 10.8.2 WHOLE Blood for Zr determination-designated USA sites only ............ 56 10.8.3 Aldosterone determination – North American Sites ONLY ..................... 57 10.8.4 Renin sample processing – North American Sites ONLY........................ 57 10.8.5 S-Galectin-3, S-Insulin, P-BNP, P-PTH and HbA1c sample processing– North American Sites ONLY.................................................................................... 57 10.8.6 Urine collections ....................................................................................... 57 10.8.7 Urine for Zr determination-designated USA sites only ............................ 59 10.8.8 Urine for sediment and Culture ................................................................. 60 10.8.9 Urine Chemistry – All North American Sites ONLY ............................... 60 10.9 Clinical Procedures and Observations .............................................................. 61 10.9.1 ECG........................................................................................................... 61 10.9.2 Concomitant Medications ......................................................................... 61 10.9.3 Physical Examination................................................................................ 62 10.9.4 Urine Pregnancy Test ................................................................................ 62 10.9.5 Meals and Dose Administration................................................................ 62 11 ADVERSE EVENT REPORTING........................................................................... 63 11.1 Investigator Reporting Requirements ............................................................... 63 11.2 Definitions......................................................................................................... 63 11.3 Breaking the Blind ............................................................................................ 65 12 STATISTICAL CONSIDERATIONS...................................................................... 66 12.1 Study Populations ............................................................................................. 66 12.2 Primary S-K Hypothesis ................................................................................... 66 12.3 Primary S-K Endpoint....................................................................................... 66 12.4 Additional S-K Endpoints ................................................................................. 67 12.5 Additional Endpoints ........................................................................................ 67 12.6 Sample Size Calculations .................................................................................. 68 12.7 Overall Type I Error Control ...........................................................................
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