Clinical Trials List
2023-12-01 - 2029-06-30
Phase III
Recruiting8
ICD-10N05.0
Unspecified nephritic syndrome with minor glomerular abnormality
ICD-10N05.1
Unspecified nephritic syndrome with focal and segmental glomerular lesions
ICD-10N05.6
Unspecified nephritic syndrome with dense deposit disease
ICD-10N05.7
Unspecified nephritic syndrome with diffuse crescentic glomerulonephritis
ICD-10N05.8
Unspecified nephritic syndrome with other morphologic changes
ICD-10N06.0
Isolated proteinuria with minor glomerular abnormality
ICD-10N06.1
Isolated proteinuria with focal and segmental glomerular lesions
ICD-10N06.6
Isolated proteinuria with dense deposit disease
ICD-10N06.7
Isolated proteinuria with diffuse crescentic glomerulonephritis
ICD-10N06.8
Isolated proteinuria with other morphologic lesion
ICD-10N07.0
Hereditary nephropathy, not elsewhere classified with minor glomerular abnormality
ICD-10N07.1
Hereditary nephropathy, not elsewhere classified with focal and segmental glomerular lesions
ICD-10N07.6
Hereditary nephropathy, not elsewhere classified with dense deposit disease
ICD-10N07.7
Hereditary nephropathy, not elsewhere classified with diffuse crescentic glomerulonephritis
ICD-10N07.8
Hereditary nephropathy, not elsewhere classified with other morphologic lesions
ICD-10N14.0
Analgesic nephropathy
ICD-10N14.1
Nephropathy induced by other drugs, medicaments and biological substances
ICD-10N14.2
Nephropathy induced by unspecified drug, medicament or biological substance
ICD-10N14.3
Nephropathy induced by heavy metals
ICD-10N14.4
Toxic nephropathy, not elsewhere classified
ICD-10N15.0
Balkan nephropathy
ICD-10N15.8
Other specified renal tubulo-interstitial diseases
ICD-9583.89
Nephritis and nephropathy, not specified as acute or chronic, with other specified pathological lesion in kidney
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults with IgA Nephropathy (The BEYOND Study)
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Sponsor
Novartis Pharma AG or its affiliates outside of the EEA
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
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
- FAN-CHI CHANG Division of Nephrology
- - - Division of Nephrology
- YU-HSIANG CHOU Division of Nephrology
- 黃道民 Division of Nephrology
- 陳怡婷 Division of Nephrology
- CHUN-FU LAI Division of Nephrology
- WEN-CHIH CHIANG Division of Nephrology
- 潘思宇 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
Co-Principal Investigator
- 王智賢 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tso-Hsiao Chen Division of Nephrology
- Yuh-Mou Sue Division of Nephrology
- Chung-Te Liu Division of Nephrology
- Yueh-Lin Wu
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
collection from Baseline to Week 40
Inclution Criteria
opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the
report must be available for review by the Sponsor or designee prior to randomization. If
biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion
with the Sponsor.
3. eGFR ≥ 30 mL/min/1.73 m2
at Screening based on the 2021 CKD-EPI equation
(Inker, 2021a) (for the exploratory cohort only: eGFR of ≥ 20 to < 30 mL/min/1.73 m2
).
4. Total urine protein ≥ 1.0 g/day or UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate
24-hour urine collection at Screening by a central laboratory.
5. Stable on a maximally tolerated dose of ACEi and/or ARB for at least 12 weeks prior to
Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated
dose of SGLT2i, ERAs, and/or MRAs for at least 12 weeks prior to Screening for the
treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i,
ERAs, and/or MRAs for the duration of the study.
6. Screening weight of 45 to 150 kg.
Exclusion Criteria
disorders, infections, autoimmune disorders or neoplasias.
2. Diagnosis of IgA Vasculitis.
3. Current or history of nephrotic syndrome.
4. Average blood pressure > 150/90 mm Hg (systolic/diastolic) from 3 readings obtained at
the initial Screening visit. If blood pressure is too high, the 3 readings may be repeated
once within the Screening period if clinically appropriate as per the Investigator.
The Estimated Number of Participants
-
Taiwan
14 participants
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Global
292 participants
