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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03762850




Registration number
NCT03762850
Ethics application status
Date submitted
27/11/2018
Date registered
4/12/2018

Titles & IDs
Public title
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy
Scientific title
A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy
Secondary ID [1] 0 0
2017-004605-41
Secondary ID [2] 0 0
021IGAN17001
Universal Trial Number (UTN)
Trial acronym
PROTECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunoglobulin A Nephropathy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - sparsentan
Treatment: Drugs - irbesartan
Treatment: Drugs - Dapagliflozin

Experimental: sparsentan - Double-blind: Sparsentan will be administered daily as a 200-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400- mg and continue treatment to Week 110.

Active comparator: irbesartan - Double-blind: Irbesartan will be administered daily as a 150-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg and continue treatment to Week 110.

Experimental: dapagliflozin + sparsentan (Sub study) - OLE Sub study: Dapagliflozin will be administered daily as a 5-mg oral tablet, in addition to 400-mg of Sparsentan, for a period of 12 weeks.

Experimental: sparsentan (Sub Study) - OLE Sub study: Sparsentan will be administered daily as a dose of 400-mg for a period of 12 weeks.


Treatment: Drugs: sparsentan
Target dose of 400 mg daily

Treatment: Drugs: irbesartan
Target dose of 300 mg daily

Treatment: Drugs: Dapagliflozin
Target dose of 10 mg daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36
Timepoint [1] 0 0
Baseline (Day 1) and at Week 36
Secondary outcome [1] 0 0
Total Slope of Estimated Glomerular Filtration Rate (eGFR) Over a 110-week Period
Timepoint [1] 0 0
From Day 1 to Week 110
Secondary outcome [2] 0 0
Annualized Slope of eGFR Following the Initial Acute Effect of Randomized Treatment (Chronic Slope)
Timepoint [2] 0 0
From Week 6 to Week 110 post randomization

Eligibility
Key inclusion criteria
Key Inclusion Criteria for the Double-Blind Period:

* Age 18 years or older at screening
* Biopsy-proven primary IgAN
* Proteinuria of =1 g/day at screening
* eGFR =30 mL/min/1.73 m2 at screening
* Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (maximum tolerated dose and at least one-half of the maximum labeled dose)
* Systolic BP =150 mmHg and diastolic BP =100 mmHg at screening
* Willing to undergo change in ACEI and/or ARB and anti-hypertensive medications
* Agree to contraception

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria for the Double-Blind Period:

* IgAN secondary to another condition
* Presence of cellular glomerular crescents in >25% of glomeruli on renal biopsy (if biopsy available within 6 months of screening)
* Chronic kidney disease (CKD) in addition to IgAN
* History of organ transplantation, with exception of corneal transplants
* Require any prohibited medications
* Treatment of systemic immunosuppressive medications (including corticosteroids) for >2 weeks within 3 months of screening
* History of heart failure or previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal nocturnal dyspnea, ascites, and/or peripheral edema
* Clinically significant cerebrovascular disease or coronary artery disease within 6 months of screening
* Jaundice, hepatitis, or known hepatobiliary disease or elevations of transaminases (ALT/AST) >2 times upper limit of normal at screening
* History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years
* Hematocrit value <27% (0.27 V/V) or hemoglobin value <9 g/dL (90 g/L) at Screening
* Potassium >5.5 mEq/L (5.5 mmol/L) at Screening
* History of alcohol of illicit drug use disorder
* History of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist, including sparsentan or irbesartan, or has a hypersensitivity to any of the excipients in the study medications
* For female: Pregnancy, or planning to become pregnant during the course of the study, or breastfeeding
* Participation in a study of another investigational product within 28 days of screening

Key Inclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 visit:

* Completed participation in the double-blind period, including the Week 114 visit
* Did not permanently discontinue study medication during the double-blind period
* Agree to contraception

Key Exclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 and Week 114 visits:

* Progression to end-stage renal disease (ESRD) requiring renal replacement therapy (RRT)
* Development of any criteria for discontinuation of study medication or discontinuation from the study, between Week 110 and Week 114
* Patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 110 and Week 114
* eGFR =20 mL/min/1.73 m2 at Week 110
* Female patient is pregnant or breastfeeding

Key Inclusion Criteria for the OLE Sparsentan + SGLT2 Inhibitor Sub study:

* Participating in the open-label extension and is willing and able to provide signed informed consent for participation in the open-label extension period Sub study
* A urine protein excretion value of =0.3 g/day.
* An eGFR of =25 mL/min/1.73m2
* On a stable dose of sparsentan for =8 weeks in the open-label extension period that is the maximum tolerated dose.

Key Exclusion Criteria for the OLE Sparsentan + SGLT2 Inhibitor Sub study:

* Progressed to ESRD requiring RRT
* Initiated or changed dose of a systemic immunosuppressive medication (including systemic steroids) within 12 weeks
* Taking an SGLT2 inhibitor within 12 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
Accrual to date
Final
406
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Travere Investigational Site - Concord
Recruitment hospital [2] 0 0
Travere Investigational Site - Gosford
Recruitment hospital [3] 0 0
Travere Investigational Site - Kingswood
Recruitment hospital [4] 0 0
Travere Investigational Site - New Lambton Heights
Recruitment hospital [5] 0 0
Travere Investigational Site - Randwick
Recruitment hospital [6] 0 0
Travere Investigational Site - St Leonards
Recruitment hospital [7] 0 0
Travere Investigational Site - Birtinya
Recruitment hospital [8] 0 0
Travere Investigational Site - Adelaide
Recruitment hospital [9] 0 0
Travere Investigational Site - Reservoir
Recruitment hospital [10] 0 0
Travere Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2305 - New Lambton Heights
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2031 - Randwick
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
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4575 - Birtinya
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3073 - Reservoir
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
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Greater Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Travere Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Radko Komers, MD, PhD
Address 0 0
Travere Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Requests for clinical trial data, including language stating its intended use, should be directed to datarequest@travere.com. If approved, the requested information will be provided to the requestor after signing a data access agreement. Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication. Travere reserves the right to decline or recommend modifications to a request if it does not comply with the data sharing policy or if it is determined that the request is made by a biased source.
When will data be available (start and end dates)?
Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication.
Available to whom?
Requires submission and approval of intended use and a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03762850