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New treatment option for Primary IgA Nephropathy
Official title A Study of SHR-2173 in Participants With Primary IgA Nephropathy
ClinicalTrials.gov ID: NCT07354932
What this study is testing
What is SHR-2173 injection?
SHR-2173 injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for primary iga nephropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with Primary IgA Nephropathy(IgAN). The study consists of a screening period, a run-in period, a 48-week double-blind treatment period, and a 12-week follow-up period.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female participants aged 18 or older
- Body weight ≥35 kg, BMI\<37.5 kg/m2
- At screening, 24-hour urinary protein quantification ≥1 g/ day, or 24-hour UPCR≥0.7 g/g
- eGFR≥30 mL/ minute /1.73 m2 at screening
- Female people with fertility or male participants whose partners are women of childbearing age must avoid donating sperm/eggs from the date of...
You likely can't join if
- \- 1、Presence of any of the following medical histories or comorbidities:
- Renal pathology consistent with IgAN, but secondary factors could not be excluded by investigator evaluation, including but not limited to: secondary...
- A history of organ transplantation;
- A history of splenectomy;
- Presence or history of malignancy within 5 years before screening (note: skin squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in...
- A history of anaphylaxis such as generalized urticaria, angioedema, or anaphylaxis, or a known history of allergy to the study drug or any component...
See the full eligibility criteria
- Male and female participants aged 18 or older
- Body weight ≥35 kg, BMI\<37.5 kg/m2
- At screening, 24-hour urinary protein quantification ≥1 g/ day, or 24-hour UPCR≥0.7 g/g
- eGFR≥30 mL/ minute /1.73 m2 at screening
- Female people with fertility or male participants whose partners are women of childbearing age must avoid donating sperm/eggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to...
- \- 1、Presence of any of the following medical histories or comorbidities:
- Renal pathology consistent with IgAN, but secondary factors could not be excluded by investigator evaluation, including but not limited to: secondary to systemic diseases, infections, autoimmune diseases or tumors;
- A history of organ transplantation;
- A history of splenectomy;
- Presence or history of malignancy within 5 years before screening (note: skin squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ with complete resection and no evidence of recurrence are...
- A history of anaphylaxis such as generalized urticaria, angioedema, or anaphylaxis, or a known history of allergy to the study drug or any component of the study drug 2、Use of any of the following drugs/treatments or...
- Received systemic glucocorticoid therapy (including gut-targeted budesonide, etc.) within 12 weeks before randomization (Note: except those not used within 4 weeks before randomization and received prednisone ≤0.5mg/kg...
- Receivied immunosuppressive therapy within 12 weeks before randomization;
- Received any investigational drug within 4 weeks before randomization or within the 5 half-lives of the trial drug, whichever was longer;
- Received a live / attenuated live vaccine administered within 4 weeks before randomization 3、History and examination related to infection:
- A history of infection (viral, bacterial, fungal, parasitic infection) within 3 months prior to screening, resulting in hospitalization and/or parenteral systemic antimicrobial therapy; Or a history of infection...
- Tuberculosis (TB) or occult TB infection (one of the following conditions) :
- Presence of active TB or clinical symptoms of active TB at screening;
- Signs of active TB on imaging examination within 3 months before screening 4、 General situation: 1) Pregnant or lactating women; 2) Investigators determine that there are circumstances that affect the safety and how...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.