Blood test may help doctors Fine-Tune kidney disease therapy

NCT ID NCT07822100

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether regularly checking a marker called Gd-IgA1 can help doctors adjust treatment for IgA nephropathy, a kidney disease. Adults with biopsy-confirmed IgA nephropathy or IgA vasculitis-associated nephritis receive Nefecon or telitacicept. Half have Gd-IgA1 checked five times during the study to guide medication changes, while the other half receive standard care. The study measures changes in protein in the urine and kidney function to see if the monitoring approach works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gd-IgA1 monitoring to guide medication adjustment in people treated with Nefecon or telitacicept
What this could lead to
If it works, doctors could use regular Gd-IgA1 checks to tailor IgA nephropathy treatment and better protect kidney function.
What could go wrong
This is an open-label study, so expectations may influence results. Monitoring adds tests and visits, and it may not improve outcomes over standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 374 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female, between 18 and 75 years age; * Biopsy confirmed diagnosis of primary IgA nephropathy or IgA Vasculitis-Associated Nephritis; * Persistent proteinuria, defined as: two separate measurements (with an interval of ≥ 4 weeks) of 24-hour urinary protein excretion (24hUTP) ≥ 0.5 g/day, or urine protein-to-creatinine ratio (UPCR) ≥ 0.44 g/g; * Estimated glomerular filtration rate (eGFR) (CKD-EPI) ≥ 30 ml/min per 1.73m\^2; * Have received the angiotensin converting enzyme Inhibitors(ACEI) / angiotensin receptor blocker(ARB) standard treatment for 4 weeks prior to randomization; * Intending to receive or having received Nefecon or telitacicept treatment for ≤ 2 weeks at the time of screening. Exclusion Criteria: * Secondary IgA nephropathy (excluding IgA vasculitis) caused by ankylosing spondylitis, systemic lupus erythematosus, viral hepatitis, liver cirrhosis, etc.; * With a known history or clinical evidence of concurrent renal diseases other than IgA nephropathy; * Treating with systemic corticosteroids or immunosuppressants including cyclophosphamide, azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, rituximab, etc. within 3 months prior to randomizing; * Have initiated or had a dose adjustment of leflunomide, tripterygium wilfordii or hydroxychloroquine within 3 months prior to randomizing; * Active tuberculosis or latent carrier without treatment; * Herpes zoster infected patients or patients with positive HIV antibody, positive HCV antibody or HBV infection (According to the HBV screening test, a) the HBsAg-positive; b) HBsAg-negative and HBcAb-positive, the HBV-DNA should be tested to determine the situation: the HBV-DNA positive subjects should be excluded, while the HBV-DNA negative subjects can participated in.) * Suffering from following gastrointestinal diseases: gastric ulcer bleeding within the past 6 months, active inflammatory bowel disease, a history of major gastrointestinal surgery (e.g., gastrectomy, gastroenterostomy, or bowel resection), or pancreatic injury/pancreatitis within the past 6 months; * A confirmed history of osteoporosis or osteonecrosis of the femoral head; * Type 1 or type 2 diabetes with poor glycemic control (HbA1c \> 8%); * Body mass index (BMI) \< 18.5 kg/m².; * Systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg; * Decreased lymphocyte count (absolute value \< 1.1 × 10⁹/L) or decreased immunoglobulin G (IgG \< 6 g/L). * Hepatic dysfunction, meeting any of the following: a) Child-Pugh Class C liver dysfunction; b) ALT or AST \> 2 × upper limit of normal (ULN), or total bilirubin \> 2 × ULN at screening; c) history of hepatic encephalopathy, esophageal varices, or portosystemic shunt surgery; * Evidence of urinary tract obstruction or dysuria. * A history of solid organ transplantation, hematopoietic stem cell/cell/bone marrow transplantation, or kidney transplantation. * Pregnancy, lactation, female participants with childbearing plans during the trial or within 6 months of its completion, and male participants planning to conceive or donate sperm during the trial or within 3 months of its completion; * With a history of malignant tumors within the past 5 years (excluding cutaneous squamous cell carcinoma or basal cell carcinoma); * Allergy to human-derived biologics; * Nephrotoxic drugs is unavoidable during the study period; * Not suitable for the study judged by investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The places running it

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Contacts and locations

Locations

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100010, China

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