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Immunomodulator
Telitacicept for IgA Nephropathy
Phase 2
Waitlist Available
Research Sponsored by RemeGen Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and eot visit.
Summary
This trial tests an injectable medication called Telitacicept on patients with a kidney disease known as IgA nephropathy. The medication aims to help by adjusting the immune system to reduce kidney damage.
Eligible Conditions
- Immunoglobulin A Nephropathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and eot visit.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and eot visit.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in 24-hour urine protein at Week 24.
Secondary study objectives
Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
Change from baseline in immunological parameters (IgA, IgG, IgM, C3, C4, and B lymphocytes) at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
Change from baseline in urine protein-to-creatinine ratio (UPCR) and urine albumin-to-creatinine ratio (UACR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48;
Other study objectives
Biomaker endpoints serum concentration
Immunogenicity endpoints
Pharmacokinetic endpoints
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Telitacicept 240mgExperimental Treatment1 Intervention
Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses
Group II: Telitacicept 160mgExperimental Treatment1 Intervention
Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses
Group III: PlaceboPlacebo Group1 Intervention
Placebo subcutaneous injection once weekly, and a total of 24 doses
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Who is running the clinical trial?
RemeGen Co., Ltd.Lead Sponsor
82 Previous Clinical Trials
11,043 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have important abnormal test results from your lab tests.Your kidney function has decreased rapidly by more than 15 ml/min during the screening process.People with weakened immune systems.You have certain types of kidney diseases that could make it hard to understand the study results.Your average 24-hour urine protein level is greater than 0.75 grams.Your kidney function, as measured by estimated GFR, is above a certain level.You are taking certain medications for high blood pressure.You have been diagnosed with IgA nephropathy through a kidney biopsy.You have had an organ transplant or are planning to have one during the study.You have a specific kidney condition called secondary IgA nephropathy.You have had serious heart or brain problems in the last 12 weeks.You are 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Telitacicept 160mg
- Group 2: Telitacicept 240mg
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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