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A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

Primary Purpose

Type 2 Diabetes Mellitus, Chronic Kidney Diseases

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Renal Autologous Cell Therapy (REACT)
Sponsored by
Prokidney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring REACT®, Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The participant is male or female, 30 to 80 years of age on the date of informed consent.
  2. The participant has a clinical diagnosis of T2DM in their health record.
  3. The participant has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in their health record.
  4. The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit.
  5. The participant has a documented clinical diagnosis of an eGFR greater than or equal to 20 and less than or equal to 50 mL/min/1.73m², not requiring renal dialysis.
  6. The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than or equal to 300 and less than or equal to 5,000 mg/g.

Exclusion Criteria:

  1. The participant has a history of type 1 diabetes mellitus.
  2. The participant has a history of renal transplantation.
  3. The participant has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening, across 3 measurements while seated.
  4. The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.

Sites / Locations

  • Paradise Clinical Research Group LLCRecruiting
  • IMD Clinical TrialsRecruiting
  • Advanced Medical Research, LLC
  • Medicine and Nephrology AssociatesRecruiting
  • Academic Medical Research InstituteRecruiting
  • Allameh Medical Corporation
  • Valley Clinical TrialsRecruiting
  • Integrity Medical DiscoveryRecruiting
  • UC Davis Medical Group GI UnitRecruiting
  • North America Research InstituteRecruiting
  • West Broward Research InstituteRecruiting
  • Florida Kidney PhysiciansRecruiting
  • University of FloridaRecruiting
  • New Phase Clinical TrialsRecruiting
  • Genesis Clinical ResearchRecruiting
  • American Clinical Trials
  • Boise Kidney and Hypertension InstituteRecruiting
  • Care InstituteRecruiting
  • Insight Hospital & Medical Center ChicagoRecruiting
  • The University of Chicago Medical CenterRecruiting
  • University of IowaRecruiting
  • Washington Nephrology AssociatesRecruiting
  • University of MichiganRecruiting
  • St. Clair Nephrology ResearchRecruiting
  • Saint Louis UniversityRecruiting
  • Nevada Kidney Disease & Hypertension CenterRecruiting
  • Seacoast Kidney & Hypertension SpecialistsRecruiting
  • UNC Chapel HillRecruiting
  • Rhode Island HospitalRecruiting
  • Dunes Clinical ResearchRecruiting
  • Knoxville Kidney CenterRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Texas Tech Health SciencesRecruiting
  • Plaza NephrologyRecruiting
  • Clinical Research Strategies, IncRecruiting
  • United Memorial Medical CenterRecruiting
  • St. George HospitalRecruiting
  • Lakeridge Health Corporation-OshawaRecruiting
  • Far Eastern Memorial HospitalRecruiting
  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and WelfareRecruiting
  • China Medical University HospitalRecruiting
  • Taipei Medical University HospitalRecruiting
  • Tri-Service General HospitalRecruiting
  • Taipei Municipal Wanfang Hospital Managed by Taipei Medical UniversityRecruiting
  • Royal London HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

Participants randomized to Cohort 1 will receive 2 sham injections of REACT. Second injection to occur 3 months (+30 days) after the first REACT injection. Sham procedures simulate real procedure. No tissue is taken during biopsy and nothing is injected into kidney for injection.

Participants randomized to Cohort 2 will receive 2 injections of REACT. The second injection to occur 3 months (+30 days) after the first REACT injection.

Outcomes

Primary Outcome Measures

Primary Composite Endpoint
The time from first injection to the earliest of: At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or Renal or cardiovascular death

Secondary Outcome Measures

Secondary Composite Endpoint
The time from first injection to the earliest of: At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant Increase of UACR of at least 30% and of at least 30mg/g, using the random urine microalbumin/urine creatinine ratio sustained for 90 days or Renal or Cardiovascular death

Full Information

First Posted
October 18, 2021
Last Updated
August 31, 2023
Sponsor
Prokidney
Collaborators
Iqvia Pty Ltd, PPD
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1. Study Identification

Unique Protocol Identification Number
NCT05099770
Brief Title
A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
Official Title
A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
February 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prokidney
Collaborators
Iqvia Pty Ltd, PPD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.
Detailed Description
Randomized multi-center, blinded intervention, two cohort, study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants will undergo sham procedures and be followed to the global trial end date. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed to the global trial end date. This event driven study is estimated to have a total maximum duration of 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Chronic Kidney Diseases
Keywords
REACT®, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Sham Comparator
Arm Description
Participants randomized to Cohort 1 will receive 2 sham injections of REACT. Second injection to occur 3 months (+30 days) after the first REACT injection. Sham procedures simulate real procedure. No tissue is taken during biopsy and nothing is injected into kidney for injection.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Participants randomized to Cohort 2 will receive 2 injections of REACT. The second injection to occur 3 months (+30 days) after the first REACT injection.
Intervention Type
Biological
Intervention Name(s)
Renal Autologous Cell Therapy (REACT)
Intervention Description
Participants will receive either 2 REACT injections or 2 Sham REACT injections into biopsied and non-biopsied contralateral kidneys 3 months apart.
Primary Outcome Measure Information:
Title
Primary Composite Endpoint
Description
The time from first injection to the earliest of: At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or Renal or cardiovascular death
Time Frame
up to 60 Months
Secondary Outcome Measure Information:
Title
Secondary Composite Endpoint
Description
The time from first injection to the earliest of: At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant Increase of UACR of at least 30% and of at least 30mg/g, using the random urine microalbumin/urine creatinine ratio sustained for 90 days or Renal or Cardiovascular death
Time Frame
up to 60 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant is male or female, 30 to 80 years of age on the date of informed consent. The participant has a clinical diagnosis of T2DM in their health record. The participant has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in their health record. The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit. The participant has a documented clinical diagnosis of an eGFR greater than or equal to 20 and less than or equal to 50 mL/min/1.73m², not requiring renal dialysis. The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than or equal to 300 and less than or equal to 5,000 mg/g. Exclusion Criteria: The participant has a history of type 1 diabetes mellitus. The participant has a history of renal transplantation. The participant has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening, across 3 measurements while seated. The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Schmidt
Phone
1-802-310-9479
Email
jessica.schmidt@iqvia.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mignon Keaton
Email
mignon.keaton@prokidney.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Johns
Organizational Affiliation
SVP Clinical Operations, ProKidney
Official's Role
Study Director
Facility Information:
Facility Name
Paradise Clinical Research Group LLC
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymundo Bautista, MD
Facility Name
IMD Clinical Trials
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Carabello, MD
Phone
323-868-4400
Facility Name
Advanced Medical Research, LLC
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medicine and Nephrology Associates
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Kabbany, MD
Phone
562-596-1667
Facility Name
Academic Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed El-Shahawy, MD
Phone
323-725-7149
Facility Name
Allameh Medical Corporation
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Valley Clinical Trials
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moufid Nemeh, MD
Phone
818-885-0063
Facility Name
Integrity Medical Discovery
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minou Tran, MD
Phone
323-515-5547
Facility Name
UC Davis Medical Group GI Unit
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prasanth Surampudi, MD
Phone
916-734-3723
Facility Name
North America Research Institute
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aamir Jamal, MD
Phone
800-797-1695
Facility Name
West Broward Research Institute
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paramjit Kalirao, MD
Phone
954-739-2221
Facility Name
Florida Kidney Physicians
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wayne Kotzker
Phone
954-463-0112
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Segal, MD
Phone
352-265-4845
Facility Name
New Phase Clinical Trials
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Letica Adan, MD
Phone
305-858-4300
Facility Name
Genesis Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Navarro, MD
Phone
813-873-1016
Facility Name
American Clinical Trials
City
Acworth
State/Province
Georgia
ZIP/Postal Code
30101
Country
United States
Individual Site Status
Terminated
Facility Name
Boise Kidney and Hypertension Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
836432
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Henderson
Phone
208-472-0518
Email
amy.henderson@frenovarenalresearch.com
First Name & Middle Initial & Last Name & Degree
LuAnn Schneider
Phone
208-472-0518
Email
LuAnn.Schneider@frenovarenalresearch.com
Facility Name
Care Institute
City
Chubbuck
State/Province
Idaho
ZIP/Postal Code
83202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hira Siktel, MD
Phone
208-904-4780
Facility Name
Insight Hospital & Medical Center Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rizwan Moinuddin, MD
Phone
312-567-2000
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Ko, MD
Phone
773-702-1000
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mony Fraer, MD
Phone
319-356-4409
Facility Name
Washington Nephrology Associates
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Varagur Bala Subramanian
Phone
301-907-2484
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Yevzlin, MD
Phone
734-615-3217
Facility Name
St. Clair Nephrology Research
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Bellovich, DO
Phone
586-218-5800
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kana Miyata, MO
Phone
314-977-2650
Facility Name
Nevada Kidney Disease & Hypertension Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Kantor, MD
Phone
702-726-5828
Facility Name
Seacoast Kidney & Hypertension Specialists
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sucharit Joshi, MD
Phone
603-436-3433
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randy Detwiler, MD
Phone
919-843-0832
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reginald Gohh
Phone
401-444-4000
Facility Name
Dunes Clinical Research
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashar Luqman, MD
Phone
605-217-7749
Facility Name
Knoxville Kidney Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendra Hendon, MD
Phone
865-692-3462
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Burgner, MD
Phone
615-936-1179
Facility Name
Texas Tech Health Sciences
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adeel Ahmed, MD
Phone
915-215-8000
Facility Name
Plaza Nephrology
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Merszei, MD
Phone
713-520-6790
Facility Name
Clinical Research Strategies, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Kwoh, MD
Facility Name
United Memorial Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77091
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wasae Tabibi, MD
Phone
281-618-8500
Facility Name
St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Badve, MD
Phone
+61731765080
Facility Name
Lakeridge Health Corporation-Oshawa
City
Oshawa
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Steele, MD
Phone
905-576-8711
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Sen Peng, MD
Phone
+88691751981
Facility Name
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai-Szu Wu, MD
Phone
886970405050
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping-Chin Lai, MD
Phone
+886975368125
Facility Name
Taipei Medical University Hospital
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chin-Chin Kao, MD
Phone
+8862273721813577
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Juei Hsu, MD
Phone
886939126009
Facility Name
Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuh-Mou Sue, MD
Phone
8860229307930
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
E1 1FR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kieran McCafferty, MD
Phone
+442035941737

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

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