BridgeMD
New treatment option for Primary IgA Nephropathy
Official title A Trial of HRS-5965 Capsule in Primary IgA Nephropathy
ClinicalTrials.gov ID: NCT07014826
What this study is testing
What is HRS-5965?
HRS-5965 is an investigational medicine, given as a pill taken by mouth, 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 multicenter, randomized, double-blind, parallel, placebo-controlled study is being conducted to evaluate the efficacy, and safety of HRS-5965 capsule for primary IgA nephropathy.
- Phase 3: a large, late-stage study
- 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
- Able and willing to provide a written informed consent；
- Weight ≥35 kg, Body mass index (BMI) \< 37.5kg /m2;
- Primary IgA nephropathy was confirmed by renal biopsy within 8 years;
- 24-UPE≥ 1.0g /24h, or 24-UPCR≥ 0.8g/g at screen, and 24-UPCR≥ 0.8g/g prior to randomization;
- eGFR≥30 ml/min/1.73m2 at screening and prior to randomization; (CKD-EPI formula)
You likely can't join if
- Allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;
- Patients with secondary IgA nephropathy as determined by the investigator;
- IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body...
- Patients with a history of immunodeficiency disease; Or in combination with other systemic diseases likely to cause proteinuria; Or with Nephrotic...
- Have any organ transplant;
- Patients with active infection of tuberculosis within 1 year prior to screening, such as liver abscess and pyelonephritis; Or people with active...
See the full eligibility criteria
- Able and willing to provide a written informed consent；
- Weight ≥35 kg, Body mass index (BMI) \< 37.5kg /m2;
- Primary IgA nephropathy was confirmed by renal biopsy within 8 years;
- 24-UPE≥ 1.0g /24h, or 24-UPCR≥ 0.8g/g at screen, and 24-UPCR≥ 0.8g/g prior to randomization;
- eGFR≥30 ml/min/1.73m2 at screening and prior to randomization; (CKD-EPI formula)
- A fertile female subject or a male subject whose partner is a fertile female, who has not had a fertility, sperm/egg donation plan from the signing of the informed consent to 1 month after the last dose, and voluntarily...
- Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.
- Receiving optimal supportive therapy including RAS blockers and stabilizing the dose for at least 12 weeks after reaching the maximum recommended dose or the maximum tolerated dose prior to randomization;
- Allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;
- Patients with secondary IgA nephropathy as determined by the investigator;
- IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial...
- Patients with a history of immunodeficiency disease; Or in combination with other systemic diseases likely to cause proteinuria; Or with Nephrotic Syndrome;
- Have any organ transplant;
- Patients with active infection of tuberculosis within 1 year prior to screening, such as liver abscess and pyelonephritis; Or people with active infection who requiring intravenous antibiotic therapy within 2 weeks...
- Patients with a history of malignant neoplasms;
- Patients with a history of severe trauma or major surgery within 12 weeks prior to screening, or who plan to undergo surgery during the study period;
- Patients with a history of blood donation or a history of severe blood loss (≥400 mL blood loss) within 12 weeks prior to screening, or who have received blood transfusions within 12 weeks prior to screening;
- The presence of a disease or medical condition determined by the investigator might affect drug absorption, distribution, metabolism, and excretion;
- As determined by the investigator, the subject has any of the following: progression or recovery of a disease;
- Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or total bilirubin exceeding 3 times the upper limit of normal (ULN) at screening;
- Participants who have participated in a clinical trial of any drug or medical device within 12 weeks prior to randomization and are expected to have residual effects of the investigational treatment (as determined by...
- Women who are pregnant or breastfeeding;
- A history of drug abuse;
- Participants who received systemic glucocorticoid or immune suppressants within 12 weeks prior to randomization and are expected to have during research；
- Participants who received biologics or cytokine inhibitor within 6 months prior to randomization and are expected to have during research；
- Any physical or mental illness or condition that, as determined by the investigator, is likely to increase the risk of the study, affect the subject's adherence to the protocol, or prevent the subject from completing...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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 Beijing, Beijing 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.