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Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) (DUPLEX)

Primary Purpose

Focal Segmental Glomerulosclerosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
sparsentan
Irbesartan
Sponsored by
Travere Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Segmental Glomerulosclerosis

Eligibility Criteria

8 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria for the Double-blind Period:

  • Sites within the US and UK: The patient is male or female aged 8 to 75 years, inclusive, weighing ≥20 kg at screening
  • Sites outside the US and UK: The patient is male or female aged 18 to 75 years, inclusive, weighing ≥20 kg at screening
  • Biopsy-proven focal segmental glomerulosclerosis (FSGS) lesion(s) or documentation of a genetic mutation in a podocyte protein associated with FSGS.
  • Urine protein/creatinine (UP/C) ≥1.5 g/g (170 mg/mmol) at screening
  • eGFR ≥30 mL/min/1.73 m2 at screening.
  • Women of childbearing potential must agree to the use of one highly reliable method of contraception from 7 days prior to the first dose of study medication until 90 days after the last dose of study medication, plus one additional barrier method during sexual activity

Key Exclusion Criteria for the Double-blind Period:

  • FSGS secondary to another condition
  • Positive serological tests of another primary or secondary glomerular disease not consistent with a diagnosis of primary or genetic FSGS
  • History of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus, or nonfasting blood glucose >180 mg/dL (10.0 mmol/L)
  • Treated with rituximab, cyclophosphamide, or abatacept within ≤3 months prior to screening; if taking other chronic immunosuppressive medications, the dosage must be stable prior to screening
  • Documented history of heart failure, coronary artery disease, or cerebrovascular disease
  • Significant liver disease
  • Positive at screening for the human immunodeficiency virus or markers indicating acute or chronic hepatitis B virus infection or hepatitis C infection
  • History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years
  • Screening hematocrit value <27% (0.27 L/L) or hemoglobin value <9 g/dL (90 g/L)
  • Screening potassium value of >5.5 mEq/L (5.5 mmol/L)
  • Extreme obesity (ie, ≥18 years of age with a body mass index (BMI) >40, or is <18 years of age with a BMI in the 99th percentile plus 5 units at screening, in whom there is a causal relationship between obesity and the development of FSGS
  • History of alcohol or illicit drug use disorder
  • History of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist
  • Female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.

Key Inclusion Criteria for the Open-label Extension Based on assessments at the Week 108 visit:

  • Complete participation in the double-blind period, including the Week 112 visit.
  • Patient received blinded study medication through the duration of the double-blind period (ie, did not permanently discontinue study medication)

Key Exclusion Criteria for the Open-label Extension Based on Assessments at Week 108 and 112 visits:

  • Progression to end-stage renal disease requiring replacement therapy
  • The patient developed criteria for discontinuation between Week 108 and Week 112
  • The patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 108 and Week 112
  • eGFR ≤20 mL/min/1.73 m2 at Week 108

Sites / Locations

  • Travere Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sparsentan for double-blind and open-label extension

Irbesartan

Arm Description

Sparsentan will be administered as a single oral morning dose; an initial dose of 400 mg daily titrating up to a target dose of 800 mg, daily

Irbesartan will be administered as a single oral morning dose; an initial dose of 150 mg daily titrating up to a target dose of 300 mg, daily

Outcomes

Primary Outcome Measures

Slope of estimated glomerular filtration rate (eGFR)
The slope of eGFR from Day 1 to Week 108. (Secondary outcome measure in non-US countries)
Proportion of patients achieving a urine protein/creatinine (UP/C) ≤1.5 g/g and a >40% reduction
Proportion of patients achieving a UP/C ≤1.5 g/g and a >40% reduction from baseline in UP/C at Week 36

Secondary Outcome Measures

Slope of eGFR
The slope of eGFR from 6 weeks post randomization at Week 108. (Primary outcome in non-US countries)
Change in eGFR from baseline
Change in eGFR from baseline to 4 weeks post-cessation of treatment at Week 112. (Percent change in eGFR in non-US countries)
Non-US countries: Percent change in eGFR
Percent change from Week 6 in eGFR at Week 108

Full Information

First Posted
April 3, 2018
Last Updated
August 31, 2023
Sponsor
Travere Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03493685
Brief Title
Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)
Acronym
DUPLEX
Official Title
A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
March 20, 2023 (Actual)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Travere Therapeutics, Inc.

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
To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).
Detailed Description
This is a randomized, multicenter, double-blind, parallel, active-control study. Approximately 300 patients aged 8 to 75 years (inclusive) will be enrolled in the study. The study will be conducted in approximately 300 study centers, globally. The investigational drug (sparsentan) is a dual-acting angiotensin receptor blocker and endothelin receptor antagonist. The active control is irbesartan. Patients who meet eligibility criteria will require washout from renin-angiotensin-aldosterone system (RAAS) blockers, if applicable prior to their first dose of study drug. Patients will be randomly assigned in a 1:1 ratio to receive either sparsentan or active control (irbesartan). After completing the double-blind portion of the study, patients may participate in the open-label extension for treatment with sparsentan if they meet eligibility criteria. Primary completion date represents the anticipated completion date of the double-blind portion of the study. Study completion date represents the anticipated completion date of the open-label extension portion of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Segmental Glomerulosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
371 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sparsentan for double-blind and open-label extension
Arm Type
Experimental
Arm Description
Sparsentan will be administered as a single oral morning dose; an initial dose of 400 mg daily titrating up to a target dose of 800 mg, daily
Arm Title
Irbesartan
Arm Type
Active Comparator
Arm Description
Irbesartan will be administered as a single oral morning dose; an initial dose of 150 mg daily titrating up to a target dose of 300 mg, daily
Intervention Type
Drug
Intervention Name(s)
sparsentan
Other Intervention Name(s)
RE-021
Intervention Description
Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Other Intervention Name(s)
Irbesartan Tablets USP
Intervention Description
target dose of 300 mg daily
Primary Outcome Measure Information:
Title
Slope of estimated glomerular filtration rate (eGFR)
Description
The slope of eGFR from Day 1 to Week 108. (Secondary outcome measure in non-US countries)
Time Frame
Week 108
Title
Proportion of patients achieving a urine protein/creatinine (UP/C) ≤1.5 g/g and a >40% reduction
Description
Proportion of patients achieving a UP/C ≤1.5 g/g and a >40% reduction from baseline in UP/C at Week 36
Time Frame
Week 36
Secondary Outcome Measure Information:
Title
Slope of eGFR
Description
The slope of eGFR from 6 weeks post randomization at Week 108. (Primary outcome in non-US countries)
Time Frame
Week 6 to Week 108
Title
Change in eGFR from baseline
Description
Change in eGFR from baseline to 4 weeks post-cessation of treatment at Week 112. (Percent change in eGFR in non-US countries)
Time Frame
Week 112
Title
Non-US countries: Percent change in eGFR
Description
Percent change from Week 6 in eGFR at Week 108
Time Frame
Week 6 to Week 108

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria for the Double-blind Period: Sites within the US and UK: The patient is male or female aged 8 to 75 years, inclusive, weighing ≥20 kg at screening Sites outside the US and UK: The patient is male or female aged 18 to 75 years, inclusive, weighing ≥20 kg at screening Biopsy-proven focal segmental glomerulosclerosis (FSGS) lesion(s) or documentation of a genetic mutation in a podocyte protein associated with FSGS. Urine protein/creatinine (UP/C) ≥1.5 g/g (170 mg/mmol) at screening eGFR ≥30 mL/min/1.73 m2 at screening. Women of childbearing potential must agree to the use of one highly reliable method of contraception from 7 days prior to the first dose of study medication until 90 days after the last dose of study medication, plus one additional barrier method during sexual activity Key Exclusion Criteria for the Double-blind Period: FSGS secondary to another condition Positive serological tests of another primary or secondary glomerular disease not consistent with a diagnosis of primary or genetic FSGS History of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus, or nonfasting blood glucose >180 mg/dL (10.0 mmol/L) Treated with rituximab, cyclophosphamide, or abatacept within ≤3 months prior to screening; if taking other chronic immunosuppressive medications, the dosage must be stable prior to screening Documented history of heart failure, coronary artery disease, or cerebrovascular disease Significant liver disease Positive at screening for the human immunodeficiency virus or markers indicating acute or chronic hepatitis B virus infection or hepatitis C infection History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years Screening hematocrit value <27% (0.27 L/L) or hemoglobin value <9 g/dL (90 g/L) Screening potassium value of >5.5 mEq/L (5.5 mmol/L) Extreme obesity (ie, ≥18 years of age with a body mass index (BMI) >40, or is <18 years of age with a BMI in the 99th percentile plus 5 units at screening, in whom there is a causal relationship between obesity and the development of FSGS History of alcohol or illicit drug use disorder History of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist Female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding. Key Inclusion Criteria for the Open-label Extension Based on assessments at the Week 108 visit: Complete participation in the double-blind period, including the Week 112 visit. Patient received blinded study medication through the duration of the double-blind period (ie, did not permanently discontinue study medication) Key Exclusion Criteria for the Open-label Extension Based on Assessments at Week 108 and 112 visits: Progression to end-stage renal disease requiring replacement therapy The patient developed criteria for discontinuation between Week 108 and Week 112 The patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 108 and Week 112 eGFR ≤20 mL/min/1.73 m2 at Week 108
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priscila Preciado, MD
Organizational Affiliation
Travere Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Travere Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Travere Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Travere Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Travere Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Travere Investigational Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Travere Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Travere Investigational Site
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Travere Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Travere Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Travere Investigational Site
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Facility Name
Travere Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Travere Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Travere Investigational Site
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
Travere Investigational Site
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Travere Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Travere Investigational Site
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Facility Name
Travere Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Travere Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Travere Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Travere Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Travere Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Travere Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Travere Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Travere Investigational Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Travere Investigational Site
City
Temple Terrace
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Facility Name
Travere Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Travere Investigational Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Travere Investigational Site
City
Nampa
State/Province
Idaho
ZIP/Postal Code
86387
Country
United States
Facility Name
Travere Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Travere Investigational Site
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Travere Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Travere Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Travere Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Travere Investigational Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Travere Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Travere Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Travere Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Travere Investigational Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Travere Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Travere Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Travere Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Travere Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Travere Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Travere Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Travere Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Travere Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89129
Country
United States
Facility Name
Travere Investigational Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Travere Investigational Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Travere Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Travere Investigational Site
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Travere Investigational Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Travere Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Travere Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Travere Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Travere Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Travere Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Travere Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Travere Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Travere Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Travere Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Travere Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Travere Investigational Site
City
Roseburg
State/Province
Oregon
ZIP/Postal Code
97471
Country
United States
Facility Name
Travere Investigational Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Travere Investigational Site
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Travere Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Travere Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Travere Investigational Site
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Travere Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Travere Investigational Site
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
Travere Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Travere Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Travere Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Travere Investigational Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Travere Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Travere Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Travere Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Travere Investigational Site
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Facility Name
Travere Investigational Site
City
Sherman
State/Province
Texas
ZIP/Postal Code
75090
Country
United States
Facility Name
Travere Investigational Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Travere Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Travere Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84115
Country
United States
Facility Name
Travere Investigational Site
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Travere Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Travere Investigational Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Travere Investigational Site
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Travere Investigational Site
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Travere Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Travere Investigational Site
City
Córdoba
ZIP/Postal Code
X5000JHGQ
Country
Argentina
Facility Name
Travere Investigational Site
City
Córdoba
ZIP/Postal Code
X5016LIG
Country
Argentina
Facility Name
Travere Investigational Site
City
Santa Fe
ZIP/Postal Code
S3000
Country
Argentina
Facility Name
Travere Investigational Site
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Travere Investigational Site
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Travere Investigational Site
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Travere Investigational Site
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2522
Country
Australia
Facility Name
Travere Investigational Site
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Travere Investigational Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Travere Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Travere Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Travere Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Travere Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Travere Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Travere Investigational Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Travere Investigational Site
City
Botucatu
ZIP/Postal Code
18618-686
Country
Brazil
Facility Name
Travere Investigational Site
City
Itaquera
ZIP/Postal Code
08270-120
Country
Brazil
Facility Name
Travere Investigational Site
City
Passo Fundo
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Travere Investigational Site
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Travere Investigational Site
City
Recife
ZIP/Postal Code
50670-901
Country
Brazil
Facility Name
Travere Investigational Site
City
Rio De Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
Facility Name
Travere Investigational Site
City
São Paulo
ZIP/Postal Code
04038-002
Country
Brazil
Facility Name
Travere Investigational Site
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Travere Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Travere Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Travere Investigational Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Travere Investigational Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Travere Investigational Site
City
Praha 10
State/Province
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Travere Investigational Site
City
Praha 2
State/Province
Praha
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Travere Investigational Site
City
Nový Jičín
ZIP/Postal Code
74101
Country
Czechia
Facility Name
Travere Investigational Site
City
Aarhus
State/Province
Region Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Travere Investigational Site
City
Kolding
State/Province
Southern Denmark
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Travere Investigational Site
City
Tallin
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Travere Investigational Site
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Travere Investigational Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Travere Investigational Site
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Travere Investigational Site
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Travere Investigational Site
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
Facility Name
Travere Investigational Site
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Travere Investigational Site
City
Nice
ZIP/Postal Code
06001
Country
France
Facility Name
Travere Investigational Site
City
Paris Cedex 15
ZIP/Postal Code
75743
Country
France
Facility Name
Travere Investigational Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Travere Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Travere Investigational Site
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Travere Investigational Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Travere Investigational Site
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Facility Name
Travere Investigational Site
City
Düsseldorf
State/Province
Westfalen
ZIP/Postal Code
40210
Country
Germany
Facility Name
Travere Investigational Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Travere Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Travere Investigational Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Travere Investigational Site
City
Hanover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Travere Investigational Site
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Travere Investigational Site
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Travere Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
Travere Investigational Site
City
Lai Chi Kok
Country
Hong Kong
Facility Name
Travere Investigational Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Travere Investigational Site
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Travere Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Travere Investigational Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Travere Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Travere Investigational Site
City
Germaneto
ZIP/Postal Code
88100
Country
Italy
Facility Name
Travere Investigational Site
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Travere Investigational Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Travere Investigational Site
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Travere Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Travere Investigational Site
City
Roma
ZIP/Postal Code
168
Country
Italy
Facility Name
Travere Investigational Site
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Travere Investigational Site
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Gyeonggi-do
ZIP/Postal Code
14068
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Facility Name
Travere Investigational Site
City
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
Travere Investigational Site
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Travere Investigational Site
City
Olsztyn
ZIP/Postal Code
10-117
Country
Poland
Facility Name
Travere Investigational Site
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Travere Investigational Site
City
Piotrków Trybunalski
ZIP/Postal Code
97-300
Country
Poland
Facility Name
Travere Investigational Site
City
Warsaw
ZIP/Postal Code
00-631
Country
Poland
Facility Name
Travere Investigational Site
City
Warsaw
ZIP/Postal Code
04-749
Country
Poland
Facility Name
Travere Investigational Site
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Travere Investigational Site
City
Łódź
ZIP/Postal Code
93-347
Country
Poland
Facility Name
Travere Investigational Site
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Travere Investigational Site
City
Carnaxide
ZIP/Postal Code
2790-134
Country
Portugal
Facility Name
Travere Investigational Site
City
Lisboa
ZIP/Postal Code
1050-099
Country
Portugal
Facility Name
Travere Investigational Site
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Travere Investigational Site
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Travere Investigational Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Travere Investigational Site
City
Setúbal
ZIP/Postal Code
2910-446
Country
Portugal
Facility Name
Travere Investigational Site
City
Vila Nova De Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Travere Investigational Site
City
Palma De Mallorca
State/Province
Baleares
ZIP/Postal Code
07120
Country
Spain
Facility Name
Travere Investigational Site
City
Lugo
State/Province
Burela
ZIP/Postal Code
27880
Country
Spain
Facility Name
Travere Investigational Site
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
Facility Name
Travere Investigational Site
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Travere Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Travere Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Travere Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Travere Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Travere Investigational Site
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
Facility Name
Travere Investigational Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Travere Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Travere Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Travere Investigational Site
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Travere Investigational Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Travere Investigational Site
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Travere Investigational Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Travere Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Travere Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Travere Investigational Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Travere Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Travere Investigational Site
City
Solna
ZIP/Postal Code
SE-171 64
Country
Sweden
Facility Name
Travere Investigational Site
City
Uppsala
ZIP/Postal Code
75237
Country
Sweden
Facility Name
Travere Investigational Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
Travere Investigational Site
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Travere Investigational Site
City
Kaohsiung City
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Travere Investigational Site
City
New Taipei City
ZIP/Postal Code
235
Country
Taiwan
Facility Name
Travere Investigational Site
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Travere Investigational Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Travere Investigational Site
City
Tainan City
ZIP/Postal Code
710
Country
Taiwan
Facility Name
Travere Investigational Site
City
Taipei City
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Travere Investigational Site
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Travere Investigational Site
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Travere Investigational Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Travere Investigational Site
City
Carshalton
State/Province
London
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Whitechapel
State/Province
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Fulwood
State/Province
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Travere Investigational Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Travere Investigational Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Travere Investigational Site
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
Travere Investigational Site
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35224732
Citation
Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
Results Reference
derived
Links:
URL
http://travere.com
Description
Corporate Website

Learn more about this trial

Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

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