Clinical Trials List
2024-09-30 - 2028-11-30
Phase III
Recruiting8
ICD-10N05.9
Unspecified nephritic syndrome with unspecified morphologic changes
ICD-9583.0
Nephritis and nephropathy, not specified as acute or chronic, with lesion of proliferative glomerulonephritis
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF POVETACICEPT IN ADULTS WITH IMMUNOGLOBULIN A NEPHROPATHY (RAINIER)
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Trial Applicant
GEORGE CLINICAL ASIA PACIFIC LIMITED
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Sponsor
Alpine Immune Sciences, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Li-Yee Hong Division of Nephrology
- Cai-Mei Zheng Division of Nephrology
- I-WEN WU Division of Nephrology
- 林冠宏 Division of Nephrology
- Mei-Yi Wu Division of Nephrology
- Chia-Te Liao Division of Nephrology
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
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YU-HSIANG CHOU Division of Nephrology
- 陳怡婷 Division of Nephrology
- CHUN-FU LAI Division of Nephrology
- SHUEI-LIONG LIN Division of Nephrology
- 黃道民 Division of Nephrology
- FAN-CHI CHANG Division of Nephrology
- - - Division of Nephrology
- 楊紹佑 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Chin Kao
- Hsi-Hsien Chen Division of Nephrology
- Yen-Chung Lin
- Te-Chao Fang
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- TUNG-MIN YU Division of Nephrology
- 蔡尚峰 Division of Nephrology
- CHENG-HSU CHEN Division of Nephrology
- 黃俊德 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
230
Dosage
80mg/PFS
Endpoints
to creatinine ratio (uPCR) at Week 36
• Total estimated glomerular filtration rate
(eGFR) slope through Week 104
Inclution Criteria
criteria apply:
1. Age ≥18 years at the time of informed consent.
2. Diagnosed IgAN, with biopsy confirmation and report available for review by the investigator.
A kidney biopsy can be performed during screening if clinically indicated and not solely for
determining eligibility.
3. The arithmetic mean of proteinuria excretion (urine protein excretion; UPE) ≥1.0 g/day or
24-hour uPCR ≥0.75 g/g of two 24-hour urine samples.
4. eGFR determined by the CKD-EPI equation:
a. Main cohort (n=approximately 480): eGFR ≥30 mL/min/1.73m2.
b. Exploratory cohort (n=approximately 40): eGFR 20 to <30 mL/min/1.73m2.
5. The arithmetic mean of two resting blood pressure measurements in the same arm on the same
day must be ≤150 mmHg systolic and ≤90 mmHg diastolic.
If the mean systolic or diastolic blood pressure does not meet eligibility, blood pressure may
be measured on a second occasion on a different day during screening. Eligibility will be
determined by the mean of two resting blood pressure measurements on the second occasion.
6. Angiotensin converting enzyme inhibitor or angiotensin II receptor blocker must be started
≥12 weeks before screening unless documented intolerance. Subject must be on maximal or
the maximally tolerated dose per investigator ≥12 weeks prior to the initial screening visit.
Note: Sparsentan is a dual angiotensin and endothelin antagonist, and the subject must be on
the maximal (or the maximally tolerated) dose for ≥12 weeks prior to the initial screening visit.
7. Sodium-glucose cotransporter-2 inhibitors, mineralocorticoid receptor antagonists, and
endothelin A receptor antagonists, are allowed if the subject has been on the same dose for
≥12 weeks prior to the initial screening visit.
8. Received all age-appropriate vaccinations per local or professional guidelines for
immunocompromised individuals, per investigator assessment.
9. Subjects who are considered subjects of childbearing potential or subjects with a partner of
childbearing potential must agree to use protocol-specified contraception during the study and
for ≥12 weeks following the last dose of IP.
Exclusion Criteria
1. Kidney biopsy report fulfills the criteria for other glomerulopathies that account for the
subject’s clinical presentation in the opinion of the investigator. (Concurrent secondary focal
segmental glomerulosclerosis due to IgAN is permitted; other concurrent glomerulopathies
must be discussed and approved by medical monitor.)
2. Have received treatment with any of the following or had any of the following procedures
within the described period prior to the initial screening visit.
a. Any prior treatment with povetacicept.
b. Systemic corticosteroids >20 mg prednisone equivalent per day or any oral formulations of
budesonide [e.g., targeted release budesonide]) within 12 weeks or any dose of systemic
corticosteroids within 4 weeks.
c. B cell or plasma cell depletion or modulation therapies (including anti-cluster of
differentiation [CD]20, anti-CD38, proteasome inhibitors, anti-B cell activating factor
and/or A proliferation inducing ligand therapies) within 24 weeks.
d. Tonsillectomy within 24 weeks.
e. Immunosuppressive agents including but not limited to cyclophosphamide, mycophenolate
mofetil/mycophenolic acid, calcineurin inhibitors, azathioprine, mercaptopurine,
leflunomide, methotrexate, Janus kinase inhibitors within 12 weeks.
i. Hydroxychloroquine use is permitted if the subject has been on a stable dose
for ≥12 weeks prior to the initial screening visit.
f. Herbal medicines containing immunosuppressive ingredients (e.g., Tripterygium wilfordii
and/or its extract), traditional Chinese herbal decoction, and traditional Chinese herbal
injections within 12 weeks.
i. Permitted traditional Chinese medicines for renal indications intended to
continue after Day 1 should be at a stable dose for 12 weeks prior to screening.
Otherwise, herbal or traditional Chinese medicines for renal indications should
be stopped prior to screening. Refer to the Study Restrictions List Manual for
additional details.
g. Complement-targeted therapies (e.g., eculizumab, ravulizumab, iptacopan, avacopan,
pegcetacoplan) within 12 weeks.
h. Any other investigational agents within 8 weeks or 5 half-lives, whichever is longer.
The Estimated Number of Participants
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Taiwan
18 participants
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Global
598 participants
