Clinical Trials List
Protocol NumberVIS649-201
NCT Number(ClinicalTrials.gov Identfier)NCT04287985
Completed
2020-03-31 - 2022-11-30
Phase II
Not yet recruiting2
Recruiting3
Study ended1
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants with Immunoglobulin A (IgA) Nephropathy
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Trial Applicant
GEORGE CLINICAL ASIA PACIFIC LIMITED
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 鄭本忠 無
- 邱鼎育 無
- Chien-Hsing Wu 無
- Wen-Chin Lee 無
- 李岳庭
- 李隆志 無
- 邱千華
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- 李進昌 無
- Chun-Yu Chen 無
- 孫樵隱 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- CHENG-HSU CHEN 無
- 蔡尚峰 無
- 吳軍毅 無
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 Not yet recruiting
Co-Principal Investigator
- Yu-Wei Chen 無
- 鄒居霖 無
- Mei-Yi Wu 無
- Li-Yee Hong 未分科
- Chia-Te Liao 無
- Cai-Mei Zheng 未分科
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Immunoglobulin A (IgA) Nephropathy
Objectives
TO evaluate the safety and efficacy of intravenously (IV) administered VIS649 over a 12-month treatment course in participants with IgAN.
Test Drug
VIS649
Active Ingredient
Dosage Form
Dosage
25 mg/mL
Endpoints
• AEs graded by severity, clinical laboratory tests, vital sign measurements, and physical examinations
• Change from baseline in uPCR (measured on natural log scale from 24-hour urine collection or the intended 24-hour urine collection) at Month 12 (ie, approximately 30 days after the 12th dose is administered)
o Change from baseline in uPCR (measured on natural log scale from 24-hour urine collection or the intended 24-hour urine
collection) at Months 9 and 16
o Change in 24-hour urine protein excretion from baseline to Months 9, 12, and 16
o Number of participants in each group achieving a ≥ 30% decline from baseline in uPCR at Months 9, 12, and 16
o Number of participants in each group achieving clinical remission
• Change from baseline in eGFR at Months 12 and 16
• Change from baseline in total serum IgA, IgG, and IgM concentrations at Months 9, 12, and 16
• Serum PK parameters
• Correlation of VIS649 PK parameters with changes in IgA, uPCR, and eGFR
• Serum ADA levels
• Change from baseline in uPCR (measured on natural log scale from 24-hour urine collection or the intended 24-hour urine collection) at Month 12 (ie, approximately 30 days after the 12th dose is administered)
o Change from baseline in uPCR (measured on natural log scale from 24-hour urine collection or the intended 24-hour urine
collection) at Months 9 and 16
o Change in 24-hour urine protein excretion from baseline to Months 9, 12, and 16
o Number of participants in each group achieving a ≥ 30% decline from baseline in uPCR at Months 9, 12, and 16
o Number of participants in each group achieving clinical remission
• Change from baseline in eGFR at Months 12 and 16
• Change from baseline in total serum IgA, IgG, and IgM concentrations at Months 9, 12, and 16
• Serum PK parameters
• Correlation of VIS649 PK parameters with changes in IgA, uPCR, and eGFR
• Serum ADA levels
Inclution Criteria
You will need to meet the following criteria to be eligible for this study:
1.Participant is a male or female ≥ 18 years of age at the time of signing the informed consent. (>= 20 years of age in Taiwan)
2.Participant has biopsy-confirmed IgAN.
3.Participant has medical records showing they have been on stable and maximally tolerated doses of either ACEI or ARB for at least 3 months prior screening. Participants should be on at least half of the maximum recommended dose. Participants who are unable to tolerate ACEI/ARB therapy may be eligible for participation in the study if their overall management of IgAN, including blood pressure control, is as per standard of care and applicable guidelines.
4.Participant has Urine Protein/Creatinine Ratio (uPCR) ≥ 0.75 g/g or 24-hour urine protein ≥ 1.0 g/d, at screening. The proteinuria should be stable.
5.Participant has eGFR ≥ 45 mL/min/1.73 m2 at screening. The eGFR should be stable.
6.Participant’s serum Immunoglobulin values must meet the following criteria :
•IgG: ≥ 700 mg/dL
•IgM: ≥ 40 mg/dL
•IgA: ≥ 70 mg/dL
7.Female participants of childbearing potential must have a negative serum pregnancy test prior to the first dose.
8.Participant is willing to adhere to contraceptive requirements outlined under “Pregnancy Risk” in this informed consent form
9.Participant or a legally authorized representative is able to understand the purpose and risks of the study and is willing to give voluntary written informed consent.
1.Participant is a male or female ≥ 18 years of age at the time of signing the informed consent. (>= 20 years of age in Taiwan)
2.Participant has biopsy-confirmed IgAN.
3.Participant has medical records showing they have been on stable and maximally tolerated doses of either ACEI or ARB for at least 3 months prior screening. Participants should be on at least half of the maximum recommended dose. Participants who are unable to tolerate ACEI/ARB therapy may be eligible for participation in the study if their overall management of IgAN, including blood pressure control, is as per standard of care and applicable guidelines.
4.Participant has Urine Protein/Creatinine Ratio (uPCR) ≥ 0.75 g/g or 24-hour urine protein ≥ 1.0 g/d, at screening. The proteinuria should be stable.
5.Participant has eGFR ≥ 45 mL/min/1.73 m2 at screening. The eGFR should be stable.
6.Participant’s serum Immunoglobulin values must meet the following criteria :
•IgG: ≥ 700 mg/dL
•IgM: ≥ 40 mg/dL
•IgA: ≥ 70 mg/dL
7.Female participants of childbearing potential must have a negative serum pregnancy test prior to the first dose.
8.Participant is willing to adhere to contraceptive requirements outlined under “Pregnancy Risk” in this informed consent form
9.Participant or a legally authorized representative is able to understand the purpose and risks of the study and is willing to give voluntary written informed consent.
Exclusion Criteria
Participants are excluded from the study if they meet any of the following criteria:
1.Participant has secondary forms of IgAN as defined by the treating physician (eg, Henoch Schӧnlein purpura, minimal change disease with IgA deposits, infection associated IgAN, or IgAN associated with hepatic cirrhosis).
2.Participant has co-existing chronic kidney disease (CKD), other than IgAN.
3.Participant has evidence of additional pathological findings in the kidney biopsy (eg, diabetic kidney disease, membranous nephropathy, or lupus nephritis). However, hypertensive vascular changes are acceptable.
4.Participant has kidney biopsy MEST or MEST-C score of T2 or C2 from the Oxford IgAN classification schema. If MEST-scoring was not performed, the presence of > 50% tubulo interstitial fibrosis or crescents in > 25% of glomeruli is exclusionary.
5.Participant has nephrotic syndrome, defined for this purpose as 24-hour urine protein > 3.5 g with concurrent hypoalbuminemia (serum albumin < 2.5 g/dL), hyperlipidemia (total cholesterol > 350 mg/dL), and edema.
6.Participant has received a solid organ transplant, including kidney.
7.Participant has received bone marrow or hematologic stem cell transplantation.
8.Participant is currently receiving systemic immunosuppression (excluding topical, ophthalmic, per rectum, or inhaled corticosteroids).
9.Participant has received systemic steroids within the 24 weeks prior to initial screening.
10.Participant has received treatment with 2 or more systemic immunosuppressive agents within 2 years prior to initial screening.
11.Participant has chronic infectious diseases (eg, chronic urinary tract infection; chronic sinusitis; bronchiectasis; active pulmonary or systemic tuberculosis; chronic viral hepatitis, such as hepatitis C or hepatitis B; or human immunodeficiency virus infection).
12.Participant has acute infectious disease at the time of screening.
13.Participant has Type 1 diabetes.
14.Participant has uncontrolled Type 2 diabetes, as evidenced by a screening hemoglobin A1c value > 8%.
15.Participant has uncontrolled blood pressure (> 140 mm Hg systolic or > 90 mm Hg diastolic),
16.Participant has a history of chronic autoimmune neurodegenerative disorder such as multiple sclerosis.
17.Participant has a known allergy or intolerance to any component of the study intervention.
18.Participant is breastfeeding.
19.Participant has poorly compensated or controlled ischemic heart disease or cardiomyopathy, as judged by the Study Doctor.
20.Participant has chronic obstructive pulmonary disease (COPD) or asthma that has required systemic steroid therapy during the prior year. If COPD is present, severity must not exceed Global Initiative for Chronic Obstructive Lung Disease 1 (mild), defined as a forced 1-second expiratory volume (FEV1) > 80% of predicted.
21.Participant has known cirrhosis or liver dysfunction, defined as presence of coagulopathy, platelet count < 100,000/µL or alanine aminotransferase > 3× upper limit of normal.
22.Participant has active malignancy or is receiving chemotherapy for malignancy, except for nonmelanoma skin cancers and cervical carcinoma in situ. Participants with prior malignancy who have been documented to be cancer-free for ≥ 5 years may be enrolled.
23.Participant is planning or scheduled to undergo a tonsillectomy. Prior tonsillectomy is acceptable (if greater than 6 months prior to screening).
24.Participant enrolled in another investigational drug or device study within 3 months prior to initial screening.
25.Participant with a pre-existing illness other than those listed above that, in the opinion of the Investigator, would place the participant at increased risk through participation in this study.
26.Participant is unable to comply with study protocol procedures and/or study visit schedules.
27.Participant with known or suspected alcohol or drug abuse that would compromise their safety or study participation, in the opinion of the Investigator.
1.Participant has secondary forms of IgAN as defined by the treating physician (eg, Henoch Schӧnlein purpura, minimal change disease with IgA deposits, infection associated IgAN, or IgAN associated with hepatic cirrhosis).
2.Participant has co-existing chronic kidney disease (CKD), other than IgAN.
3.Participant has evidence of additional pathological findings in the kidney biopsy (eg, diabetic kidney disease, membranous nephropathy, or lupus nephritis). However, hypertensive vascular changes are acceptable.
4.Participant has kidney biopsy MEST or MEST-C score of T2 or C2 from the Oxford IgAN classification schema. If MEST-scoring was not performed, the presence of > 50% tubulo interstitial fibrosis or crescents in > 25% of glomeruli is exclusionary.
5.Participant has nephrotic syndrome, defined for this purpose as 24-hour urine protein > 3.5 g with concurrent hypoalbuminemia (serum albumin < 2.5 g/dL), hyperlipidemia (total cholesterol > 350 mg/dL), and edema.
6.Participant has received a solid organ transplant, including kidney.
7.Participant has received bone marrow or hematologic stem cell transplantation.
8.Participant is currently receiving systemic immunosuppression (excluding topical, ophthalmic, per rectum, or inhaled corticosteroids).
9.Participant has received systemic steroids within the 24 weeks prior to initial screening.
10.Participant has received treatment with 2 or more systemic immunosuppressive agents within 2 years prior to initial screening.
11.Participant has chronic infectious diseases (eg, chronic urinary tract infection; chronic sinusitis; bronchiectasis; active pulmonary or systemic tuberculosis; chronic viral hepatitis, such as hepatitis C or hepatitis B; or human immunodeficiency virus infection).
12.Participant has acute infectious disease at the time of screening.
13.Participant has Type 1 diabetes.
14.Participant has uncontrolled Type 2 diabetes, as evidenced by a screening hemoglobin A1c value > 8%.
15.Participant has uncontrolled blood pressure (> 140 mm Hg systolic or > 90 mm Hg diastolic),
16.Participant has a history of chronic autoimmune neurodegenerative disorder such as multiple sclerosis.
17.Participant has a known allergy or intolerance to any component of the study intervention.
18.Participant is breastfeeding.
19.Participant has poorly compensated or controlled ischemic heart disease or cardiomyopathy, as judged by the Study Doctor.
20.Participant has chronic obstructive pulmonary disease (COPD) or asthma that has required systemic steroid therapy during the prior year. If COPD is present, severity must not exceed Global Initiative for Chronic Obstructive Lung Disease 1 (mild), defined as a forced 1-second expiratory volume (FEV1) > 80% of predicted.
21.Participant has known cirrhosis or liver dysfunction, defined as presence of coagulopathy, platelet count < 100,000/µL or alanine aminotransferase > 3× upper limit of normal.
22.Participant has active malignancy or is receiving chemotherapy for malignancy, except for nonmelanoma skin cancers and cervical carcinoma in situ. Participants with prior malignancy who have been documented to be cancer-free for ≥ 5 years may be enrolled.
23.Participant is planning or scheduled to undergo a tonsillectomy. Prior tonsillectomy is acceptable (if greater than 6 months prior to screening).
24.Participant enrolled in another investigational drug or device study within 3 months prior to initial screening.
25.Participant with a pre-existing illness other than those listed above that, in the opinion of the Investigator, would place the participant at increased risk through participation in this study.
26.Participant is unable to comply with study protocol procedures and/or study visit schedules.
27.Participant with known or suspected alcohol or drug abuse that would compromise their safety or study participation, in the opinion of the Investigator.
The Estimated Number of Participants
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Taiwan
10 participants
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Global
144 participants
