To Evaluate the Effect and Safety of Telitacicept and Standard Treatment for 6months in IgA Nephr… (NCT07098897) | Clinical Trial Compass
Active — Not RecruitingPhase 3
To Evaluate the Effect and Safety of Telitacicept and Standard Treatment for 6months in IgA Nephropathy
China150 participantsStarted 2024-08-01
Plain-language summary
The purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with Telitacicept in patients with IgA nephropathy. The control group will be observed for up to 6months without administration of Telitacicept.
This Single center, Randomized, Open Label, Comparative study will evaluate the effect and safety of and Standard treatment for 6months in IgA Nephropathy.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18\~75 years, regardless of gender.
* Clinical evaluation and renal biopsy diagnostic for IgA nephropathy.
* Average urinary protein excretion of 0.3\~3.5g/24h on two successive examinations.
* Urine Protein to Creatinine Ratio (UPCR) \>= 0.75 and \<= 6 milligram per milligram (mg/mg) during screening.
* Stable and optimal dose of Angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blockers (ARB) at least 8 weeks prior to screening.
* eGFR≥30 ml/min/1.73m2.
* Willingness to sign an informed consent.
Exclusion Criteria:
* • Secondary IgA nephropathy such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B-associated nephritis, etc.
* IgA nephropathy with significant glomerulosclerosis or cortical scarring.
* Failure to meet estimated glomerular filtration rate (eGFR) and biopsy requirement criteria.
* Rapidly progressive nephritic syndrome.
* Acute renal failure, including rapidly progressive IgA nephropathy.
* Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
* Cirrhosis, chronic active liver disease, and serious liver function damage.
* History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease).
* Any Active systemic infection or history of serious infection within one month.
* Other major organ system disease (e.g. serious cardiovascular diseases inc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete remission of proteinuria
Timeframe: Baseline/3months/6months
2
Partial remission of proteinuria
Timeframe: Baseline/3months/6months
3
Change from baseline to 6months in 24 Hours Urine Protein in g/24hrs
Timeframe: Baseline/3months/6months
4
Change from baseline to 6months in eGFR
Timeframe: Baseline/3months/6months
Trial details
NCT IDNCT07098897
SponsorThe Affiliated Hospital of Xuzhou Medical University