A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome
Phase: PHASE2
Conditions: Alport Syndrome
Sponsor: Biogen

Protocol 402-C-1603 
Reata Pharmaceuticals, Inc. 
Confidential 
Addendum 1 dated 21 April 2020 to protocol version 4.0 France, Spain, UK – 23 May 2019 
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BARDOXOLONE METHYL (RTA 402) 
402-C-1603
 
EUDRACT NUMBER: 2016-004395-22 
A PHASE 2/3 TRIAL OF THE EFFICACY AND SAFETY 
OF BARDOXOLONE METHYL IN PATIENTS WITH 
ALPORT SYNDROME 
ADDENDUM 1 DATED 21 APRIL 2020  
TO  
PROTOCOL VERSION 4.0 – 23 MAY 2019 
FRANCE, SPAIN, UNITED KINGDOM 
 
 
 
 
 
The information contained herein is confidential and the proprietary property of 
Reata Pharmaceuticals, Inc. and any unauthorized use or disclosure of such 
information without the prior written authorization of Reata Pharmaceuticals, 
Inc. is expressly prohibited. 

Protocol 402-C-1603 
Reata Pharmaceuticals, Inc. 
Confidential 
Addendum 1 dated 21 April 2020 to protocol version 4.0 France, Spain, UK – 23 May 2019 
2  

Protocol 402-C-1603 
Reata Pharmaceuticals, Inc. 
Confidential 
Addendum 1 dated 21 April 2020 to protocol version 4.0 France, Spain, UK – 23 May 2019 
3  
INVESTIGATOR’S AGREEMENT 
I have received and read the addendum to the protocol v4 dated 23 May aimed at managing the 
study during the COVID-19 emergency and agree to conduct the study according the mitigation 
measures put in place. I agree to maintain the confidentiality of all information received or 
developed in connection with this addendum.  
Printed Name of Investigator 
Signature of Investigator 
Date 

Protocol 402-C-1603 
Reata Pharmaceuticals, Inc. 
Confidential 
Addendum 1 dated 21 April 2020 to protocol version 4.0 France, Spain, UK – 23 May 2019 
5  
3.
JUSTIFICATION FOR THE ADDENDUM
Since the OMS declared the COVID-19 pandemic, various challenges exist which result in 
restrictions of visits to healthcare facilities, increased demands on the health services and 
changes to trial staff availability and resources. Participants may also be required to self-isolate, 
which introduces difficulties for Investigators to maintain medical oversight. These challenges 
could have an impact on the conduct of trials and data integrity, such as the completion of trial 
assessments, completion of trial visits, continued patient safety oversight and the provision of 
Investigational Medicinal Products (IMPs). 
As a sponsor, Reata Pharmaceuticals is committed to ensuring the safety of trial participants, 
maintaining compliance with good clinical practice (GCP), and minimizing risks to trial 
integrity. 
To face this evolving situation, Reata Pharmaceuticals has put in place some pragmatic actions to 
address the challenges of conducting research, and in ensuring the rights, safety and wellbeing of 
participants. 
This addendum outlines Reata Pharmaceuticals’ strategies to be implemented during the 
COVID-19 pandemic, to maintain ongoing safety reporting, access to study drug, continuity of 
patient care, and oversight of clinical site performance and quality. 
This document is being presented in an effort to make available information regarding the 
mitigation strategies that have been implemented for the CARDINAL study as a result of 
COVID-19.  Of course, since the nature and scope of this outbreak is rapidly evolving, Reata 
continues to monitor the situation and adjust its response as appropriate. 
The main activities this addendum addresses are: 
•
ongoing safety monitoring of the trial participants
•
continuity of IMP supply for patients
•
preservation of trial integrity through the collection of critical data

Protocol 402-C-1603 
Reata Pharmaceuticals, Inc. 
Confidential 
Addendum 1 dated 21 April 2020 to protocol version 4.0 France, Spain, UK – 23 May 2019 
11 
5.
CHANGES IN OTHER STUDY-RELATED DOCUMENTS
5.1. 
Informed Consent 
An ICF letter has been created and provided to the EC for approval in participating countries. 
Approval of the revised consent form will allow sites to obtain verbal permission from the study 
patient to share their contact information with the home health services company and conduct of 
the study visit.  After verbal agreement is obtained, written permission can be obtained at the 
next on-site study visit. 

Protocol 402-C-1603 
Reata Pharmaceuticals, Inc. 
Confidential 
Addendum 1 dated 21 April 2020 to protocol version 4.0 France, Spain, UK – 23 May 2019 
12 
6.
APPENDICES
List of memos provided to the study sites: 
1. Initial COVID-19 Guidance dated 10 March 2020
2. IP shipping instructions dated 17 March 2020
3. Lab Kit Shipping Instructions dated 19 March 2020