Clinical Trials List
2018-10-01 - 2026-12-31
Phase III
Recruiting11
Terminated1
ICD-10N05.1
Unspecified nephritic syndrome with focal and segmental glomerular lesions
ICD-9581.1
Nephrotic syndrome, with lesion of membranous glomerulonephritis
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 FOCAL SEGMENTAL GLOMERULOSCLEROSIS
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Retrophin, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 郭慧亮 無
- Ping-Chin Lai 無
- 王捷賢 無
- 林信宏 無
- Ya-Fei Yang 無
- 王怡寬 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Li-Yee Hong 無
- I-jen Chiu 無
- Mei-Yi Wu 無
- Yu-Wei Chen 無
- Cai-Mei Zheng 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- 黃道民 無
- 楊紹佑 無
- SHUEI-LIONG LIN 無
- - - 無
- VIN-CENT Wu 無
- WEN-CHIH CHIANG 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The primary efficacy endpoint is the slope of eGFR assessed at the final analysis.
The surrogate efficacy endpoint is the proportion of patients achieving a Up/C ≤1.5 g/g and a >40% reduction
from baseline in Up/C at Week 36.
Secondary Efficacy Endpoints:
The secondary efficacy endpoints are:
• The percent change from Week 6 in eGFR at Week 108
• The percent change from baseline in Up/C at Week 36 assessed at the final analysis
Other Efficacy Endpoints:
Other efficacy endpoints include:
• The absolute and percent change from baseline in eGFR at each visit
• The percent change from Week 6 in eGFR at each visit
• The proportion of patients achieving a Up/C ≤1.5 g/g and a >40% reduction from baseline in Up/C at
each visit
• The percent change from baseline in Up/C at each visit
• The time to achieve the target reduction in Up/C (ie, ≤1.5 g/g and a >40% reduction)
• The proportion of patients reaching a confirmed 40% change in eGFR, end-stage renal disease (ESRD),
or death. (ESRD is defined as initiation of renal replacement therapy [RRT], kidney transplantation, or
sustained eGFR <15 mL/min/1.73 m2 during the study
• New occurrence of, or relapse back to, nephrotic-range proteinuria (ie, Up/C >3.5 g/g) in patients who
have achieved the target reduction in Up/C (ie, ≤1.5 g/g and a >40% reduction) at any time during the study
• Changes from baseline in blood pressure at each visit
• The proportion of patients requiring intensification in immunosuppressive medication during the study
• The proportion of patients undergoing reduction in immunosuppressive medication during the study
• Changes from baseline in quality of life (QOL), measured via patient-reported outcome (PRO) at each
visit beginning with Week 12
Inclution Criteria
A patient will meet all of the following criteria to be eligible for this study.
1. The patient or parent/legal guardian (as appropriate) is willing and able to provide signed informed
consent, and where required, the patient is willing to provide assent, prior to any screening
procedures.
2. The patient has biopsy-proven primary FSGS or documentation of a genetic mutation in a podocyte
protein associated with FSGS. The biopsy may have been performed at any time in the past, but will
preferably include electron microscopy (EM) and immunofluorescence (IF) characteristics consistent
with primary FSGS. The patient may be enrolled based on light microscopy diagnosis of FSGS in
the absence of EM and/or IF analysis, provided the history (nephrotic syndrome with
hypoalbuminemia, treatment with immunosuppression) and the course of the disease are indicative of
primary FSGS, and potential secondary causes captured by the exclusion criteria have been carefully ruled out.
3. Sites within the United States (US): The patient is male or female aged 8 to 75 years, inclusive.
Sites outside the US: The patient is male or female aged 18 to 75 years, inclusive.
4. The patient has a Up/C ≥1.5 g/g at screening.
5. The patient has an eGFR ≥30 mL/min/1.73 m2 at screening.
6. The patient has a mean seated blood pressure ≥100/60 mmHg (on a maximum of 2 antihypertensive
treatments at screening, including RAAS inhibitors) and ≤160/100 mmHg (patients >18 years of age)
or ≥90/60 mmHg and ≤ the 95th percentile for age, sex, and height (patients ≤18 years of age).
7. Sexually active women of childbearing potential (WOCBP) must agree to the simultaneous use of
2 medically accepted methods of contraception from Day 1/Randomization until 90 days after the
last dose of study medication. At least one method of contraception must be highly reliable (ie, can
achieve a failure rate of <1% per year), such as stable oral, implanted, transdermal, or injected
contraceptive hormones associated with inhibition of ovulation, or an intrauterine device (IUD) in
place for at least 3 months. The other method of contraception must be a barrier method, such as a
diaphragm with spermicide or male partner’s use of male condom with spermicide. WOCBP are
defined as those who are fertile, following menarche and until becoming postmenopausal unless
permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy
and bilateral oophorectomy. A postmenopausal state is defined as amenorrhea for more than
24 consecutive months without an alternative medical cause; women on hormone replacement
therapy must have a documented plasma follicle-stimulating hormone level >40 mIU/mL. All
WOCBP must have a negative pregnancy test (urine, with positive results confirmed by serum) at
Visits 1 and 3 (Screening and Day 1/Randomization).
NOTE: Prior to menarche, pregnancy testing and contraceptive use is not required. However, the
patient and their parent/guardian must be advised that, immediately upon menarche, the patient will
be required to begin pregnancy testing and, if deemed necessary by the Investigator, initiate
contraceptive use. This requirement cannot be avoided.
8. Males must be surgically sterile (more than 3 months post-vasectomy) or must agree to the use of
medically accepted methods of contraception that are considered highly reliable from
Day 1/Randomization until 90 days after the last dose of study medication.
Exclusion Criteria
A patient who meets any of the following criteria will be excluded from this study.
1. The patient has FSGS secondary to another condition.
2. The patient has positive findings on any of the following serological tests of primary or secondary
glomerular injury: anti-nuclear antibody, anti-double stranded deoxyribonucleic acid (DNA)
antibodies, anti-neutrophil cytoplasmic antibody, rheumatoid factor, anti-glomerular basement
membrane antibodies, polyclonal antibodies identified by serum and urine protein electrophoresis,
cryoglobulins, or kappa and lambda chains.
3. The patient has an indicator of relapse from complete remission (ie, recurrence or new occurrence of
proteinuria >3.5 g/24 hours or Up/C >3.5 g/g within 30 days prior to or during screening).
4. The patient has a history of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus
(hemoglobin A1c [HbA1c] >8%), or nonfasting blood glucose >180 mg/dL at screening.
5. The patient has undergone any organ transplantation, with the exception of corneal transplants.
6. The patient requires any of the prohibited concomitant medications (see Section 15.2.1).
7. The patient has been treated with rituximab, cyclophosphamide, or abatacept within ≤3 months prior
to screening. If a patient is taking other chronic immunosuppressive medications, the dosage must be
stable for ≥1 month prior to randomization.
8. The patient has a documented history of heart failure (New York Heart Association Class II-IV)
and/or previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal
nocturnal dyspnea, ascites, and/or peripheral edema.
9. The patient has clinically significant cerebrovascular disease (transient ischemic attack or stroke)
and/or coronary artery disease (hospitalization for myocardial infarction or unstable angina, new
onset of angina with positive functional tests, coronary angiogram revealing stenosis, or a coronary
revascularization procedure) within 6 months prior to screening.
10. The patient has hemodynamically significant valvular disease.
11. The patient has jaundice, hepatitis, or known hepatobiliary disease (including asymptomatic
cholelithiasis), or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times
the upper limit of the normal range at screening.
12. The patient is positive at screening for the human immunodeficiency virus (HIV) or markers
indicating acute or chronic hepatitis B (HBV) infection (acute HBV is defined as a positive hepatitis
B surface antigen [HBsAg], hepatitis B “e” antigen [HBeAg], HBV DNA in blood or liver, or
immunoglobulin M [IgM] hepatitis B core antibody; chronic HBV is defined as a positive HBsAg
and/or HBeAg and/or HBV DNA) or hepatitis C virus (HCV) infection (defined as reactive antiHCV antibody and/or HCV RNA).
13. The patient has a history of malignancy other than adequately treated basal cell or squamous cell skin
cancer or cervical carcinoma within the past 2 years.
14. The patient has a screening hematocrit value <27% or hemoglobin value <9 g/dL.
15. The patient has a screening potassium value of >5.5 mEq/L.
16. The patient is >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.
17. The patient has a history of alcohol or illicit drug use disorder (as defined in the Diagnostic and
Statistical Manual of Mental Disorders, 5th Edition), or a reported habitual alcohol intake greater than
21 units/week within 2 years prior to screening.
18. The patient has a 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 medication.
19. The female patient is pregnant, plans to become pregnant during the course of the study, or is
breastfeeding.
20. The male patient plans to father a child during the course of the study.
21. The patient has participated in a study of another investigational product within 28 days prior to
screening, or plans to participate in such a study during the course of this study.
22. The patient has had prior exposure to sparsentan.
23. The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study,
including the ability to swallow the study medication capsules whole.
Patients with a medical condition or abnormal clinically significant laboratory screening value not listed
above that may interfere with the evaluation of sparsentan efficacy or safety will be reviewed with the
Medical Monitor before consideration of the patient for enrollment. Patients who fail screening may be rescreened up to 2 additional times. Patients who are re-screened will undergo all screening procedures and will
be assigned a new patient number. Patients will also repeat the informed consent procedure at this time.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
0 participants
