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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03493685
Registration number
NCT03493685
Ethics application status
Date submitted
3/04/2018
Date registered
10/04/2018
Titles & IDs
Public title
Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)
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Scientific 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
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Secondary ID [1]
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021FSGS16010
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Universal Trial Number (UTN)
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Trial acronym
DUPLEX
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Focal Segmental Glomerulosclerosis
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - sparsentan
Treatment: Drugs - Irbesartan
Experimental: sparsentan for double-blind and open-label extension - Sparsentan will be administered as a single oral dose; an initial dose of 400 mg daily titrating up to a target dose of 800 mg, daily
Active comparator: Irbesartan - Irbesartan will be administered as a single oral dose; an initial dose of 150 mg daily titrating up to a target dose of 300 mg, daily
Treatment: Drugs: sparsentan
Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily
Treatment: Drugs: Irbesartan
target dose of 300 mg daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Slope of Estimated Glomerular Filtration Rate (eGFR)
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Assessment method [1]
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The total eGFR slope over 2 years, defined as the slope of eGFR following initiation of randomized treatment (ie, Day 1 to Week 108). Estimates are calculated from a mixed-effects model with treatment, Baseline eGFR, analysis visit, treatment-by-analysis visit, randomization stratification factors as fixed effects, and intercept and slope for each participant as a random effect.
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Timepoint [1]
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From Day 1 to Week 108
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Primary outcome [2]
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Percentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE)
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Assessment method [2]
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Percentage of participants achieving FPRE, defined as urine protein-to-creatinine ratio (UP/C) =1.5 grams/gram (g/g) (170 milligrams per millimoles \[mg/mmol\]) and a \>40% reduction from Baseline was analyzed using a generalized linear model to model probability of achieving FPRE. Missing responses were imputed prior to analysis using multiple imputation. A generalized linear model with appropriate link function was implemented with Baseline log (UP/C), treatment, analysis visit, treatment by analysis visit interaction, and randomization strata as fixed effects. For estimates of probability of achieving FPRE, risk difference, and odds ratio, binomial distribution with logit link was used. For relative risk, Poisson distribution with log link was used. Using Rubin's approach, estimated treatment effects are combined across all imputations to obtain overall estimates for probabilities.
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Timepoint [2]
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Week 36
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Secondary outcome [1]
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Slope of eGFR Following the Initial Acute Effect of Randomized Treatment
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Assessment method [1]
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The chronic eGFR slope over 2 years, defined as the slope of eGFR following the initial acute effect of randomized treatment (ie, Week 6 to Week 108). Estimates were calculated from a mixed-effects model with linear spline (ie, change point at Week 6), which included treatment, Baseline eGFR, time from Baseline (TFB) (weeks), time from change point (TFCP) (weeks), treatment-by-TFB and treatment-by-TFCP interactions, and randomization stratification factors as fixed effects, intercept and slopes as random effects. The slope difference was tested by the null hypothesis that the sum of the treatment-by-TFB and treatment-by-TFCP interactions = 0.
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Timepoint [1]
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From Week 6 to Week 108
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Secondary outcome [2]
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Change From Baseline in eGFR to 4 Weeks Post-cessation of Randomized Treatment
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Assessment method [2]
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The change from Baseline to 4 weeks post-cessation of randomized treatment (Week 112) was analyzed via an analysis of covariance (ANCOVA) model on the natural log(eGFR) with treatment, Baseline eGFR, and randomization strata as fixed effects. Only participants who completed the 108-week treatment period were included. Estimated LS Mean and 95% CI are converted to percentages as follows: \[exponential (LS mean change from baseline in natural log(eGFR)) minus 1\] multiplied by 100. Baseline (Day 1) was defined as the last non-missing assessment prior to and including the first administration of study medication in the study including unscheduled assessments. Percent change from Baseline was calculated as "\[(Post Baseline minus Baseline value)/ Baseline value\] multiplied by 100.
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Timepoint [2]
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Baseline (Day 1) to Week 112
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Eligibility
Key inclusion 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
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Minimum age
8
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/04/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/02/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
371
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Travere Investigational Site - Concord
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Travere Investigational Site - New Lambton Heights
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Travere Investigational Site - Parkville
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Travere Investigational Site - Nedlands
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2139 - Concord
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2305 - New Lambton Heights
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2065 - Saint Leonards
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2522 - Wollongong
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4575 - Birtinya
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4102 - Woolloongabba
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5000 - Adelaide
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3050 - Parkville
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6009 - Nedlands
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Burela
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Spain
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Valencia
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Badalona
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Barcelona
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Ciudad Real
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Córdoba
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Madrid
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Majadahonda
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Málaga
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Santiago De Compostela
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Sevilla
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Zaragoza
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Sweden
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Solna
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Sweden
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Uppsala
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Taiwan
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Hualien City
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Taiwan
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Kaohsiung City
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Taiwan
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New Taipei City
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Taiwan
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Taichung
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Taiwan
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Tainan City
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Taipei City
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
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London
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United Kingdom
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Preston
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United Kingdom
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Brighton
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United Kingdom
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Cambridge
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Cardiff
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Leicester
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United Kingdom
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Manchester
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United Kingdom
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Newcastle
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United Kingdom
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Reading
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Salford
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United Kingdom
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United Kingdom
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York
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Travere Therapeutics, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT03493685
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Priscila Preciado, MD
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Address
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Travere Therapeutics, Inc.
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/85/NCT03493685/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/85/NCT03493685/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03493685