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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03762850
Ethics application status
Date submitted
27/11/2018
Date registered
4/12/2018
Date last updated
7/08/2019

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
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

Experimental: sparsentan - 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 - 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.


Treatment: Drugs: sparsentan
Target dose of 400 mg daily

Treatment: Drugs: irbesartan
Target dose of 300 mg daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Urine protein/creatinine ratio (UP/C) at Week 36 - The primary efficacy endpoint is the change from baseline in the urine protein/creatinine ratio (UP/C), based on a 24-hour urine sample, at Week 36.
Timepoint [1] 0 0
After the last patient randomized has undergone the Week 36 visit
Secondary outcome [1] 0 0
Overall eGFR change from baseline - Change in eGFR from baseline (Week 0) to 4 weeks post-cessation of randomized treatment (Week 114).
Timepoint [1] 0 0
Week 114 post-randomization
Secondary outcome [2] 0 0
eGFR over a 52-week period - The rate of change in estimated glomerular filtration rate (eGFR) over a 52-week period following the initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks post-randomization to 58 weeks post-randomization).
Timepoint [2] 0 0
Week 58 post-randomization
Secondary outcome [3] 0 0
eGFR over a 104-week period - The rate of change in estimated glomerular filtration rate (eGFR) over a 104-week period following initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks post-randomization to 110 weeks post-randomization).
Timepoint [3] 0 0
Week 110 post-randomization

Eligibility
Key inclusion criteria
Key

- 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

- Agree to contraception

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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)

- History of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (HbA1c
>8%), or nonfasting blood glucose >180 mg/dL at screening

- 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% or hemoglobin value <9 g/dL at Screening

- Potassium >5.5 mEq/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

- For male: planning to father a child during the course of the study

- Participation in a study of another investigational product within 28 days of
screening

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Retrophin Investigational Site - Concord
Recruitment hospital [2] 0 0
Retrophin Investigational Site - Gosford
Recruitment hospital [3] 0 0
Retrophin Investigational Site - Kingswood
Recruitment hospital [4] 0 0
Retrophin Investigational Site - Randwick
Recruitment hospital [5] 0 0
Retrophin Investigational Site - St Leonards
Recruitment hospital [6] 0 0
Retrophin Investigational Site - Birtinya
Recruitment hospital [7] 0 0
Retrophin Investigational Site - Adelaide
Recruitment hospital [8] 0 0
Retrophin Investigational Site - Reservoir
Recruitment hospital [9] 0 0
Retrophin 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
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2065 - St Leonards
Recruitment postcode(s) [6] 0 0
4575 - Birtinya
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3075 - Reservoir
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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California
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Bonheiden
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Brugge
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Brussels
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Gent
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Liège
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Roeselare
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Zagreb
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Czechia
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Taichung
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West Midlands
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Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Retrophin, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine the long-term (approximately 2 years) nephroprotective potential of treatment
with sparsentan as compared to an angiotensin receptor blocker in patients with
immunoglobulin A nephropathy (IgAN).
Trial website
https://clinicaltrials.gov/show/NCT03762850
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Radko Komers, MD, PhD
Address 0 0
Retrophin, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Retrophin Call Center
Address 0 0
Country 0 0
Phone 0 0
1-877-659-5518
Fax 0 0
Email 0 0
medinfo@retrophin.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03762850